EX/178 - NICNAS

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F
ile No:
EX
/178 (
STD/
1331
)


December 2012





NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)



FULL PUBLIC REPORT



Sodium Laurylglucosides
Hydroxypropylsulfonate



This Assessment has been compiled in accordance with the provisions of the
Industrial Chemicals (Notification
and Assessment) Act 1989
(Cwlth)
(the Act) and Regulations. This legislation is an Act of the Commonwealth of
Australia.

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered
by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational
health and safety. The assessment of environmental ri
sk is conducted by the Department of the Environment,
Water, Heritage and the Arts.


For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office
by appointment only at 334
-
336 Illawarra Road, Marrickville
NSW 2204.


This Full Public Report is also available for viewing and downloading from the NICNAS website or available on
request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS
Administration Coordinator at:


St
reet Address:


334
-

336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.

Postal Address:


GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.

TEL:

+ 61 2 8577 8800

FAX
:
+ 61 2 8577 8888

Website:



www.nicnas.gov.au


Director

NICNAS



TABLE OF CONTENTS


F
ULL
P
UBLIC
R
EPORT

................................
................................
................................
................................
..............

3

SUMMARY

................................
................................
................................
................................
...........................

3

Human health risk assessment

................................
................................
................................
......................

3

Environmental risk assessment

................................
................................
................................
.....................

3

Recommendations

................................
................................
................................
................................
..............

4

Regulatory Obligations

................................
................................
................................
................................
.

4

ASSESSMENT DETAILS

................................
................................
................................
................................
.....

5

1.

APPLICANT AND NOTIFICATION DETAILS

................................
................................
....................

5

2.

IDENTITY OF CHEMICAL

................................
................................
................................
...................

6

3.

COMPOSITION
................................
................................
................................
................................
.......

6

4.

PHYSICAL AND CHEMICAL PROPERTIES

................................
................................
.......................

7

5.

INTRODUCTION AND USE INFORMATION

................................
................................
.....................

7

6.

HUMAN HEALTH IMPLICATIONS

................................
................................
................................
.....

9

6.1

Exposure assessment

................................
................................
................................
...........................

9

6.1.1

Occupational exposure

................................
................................
................................
...............

9

6.1.2.

Public exposure

................................
................................
................................
..........................

9

6.2.

Human health effects assessment

................................
................................
................................
..

10

6.3.

Human health risk characterisation

................................
................................
...............................

14

6.3.1.

Occupational health and safety

................................
................................
................................

14

6.3.2.

Public health

................................
................................
................................
.............................

14

7.

ENVIRONMENTAL IMPLICATIONS

................................
................................
................................

15

7.1.

Environmental Exposure & Fate Assessment

................................
................................
...............

15

7.1.1

Environmental Exposure

................................
................................
................................
..........

15

7.1.2

Environmental fate

................................
................................
................................
...................

15

7.1.3

Predicted Environmental Concentration (PEC)

................................
................................
.......

15

7.2.

Environmental effects assessment

................................
................................
................................

16

7.2.1

Predicted No
-
Effect Concentration

................................
................................
..........................

16

7.3.

Environmental risk assessm
ent

................................
................................
................................
.....

16

A
PPENDIX
A:

P
HYSICAL AND
C
HEMICAL
P
ROPERTIES

................................
................................
...........................

17

A
PPENDIX
B:

T
OXICOLOGICAL
I
NVESTIGATIONS

................................
................................
................................
...

19

B.1.

Skin Irritation in Human Volunteers

................................
................................
.............................

19

B.2.

Irritation


eye The Hen’s Egg Test


Utilizing the Chorioallantoic Membrane (HET
-
CAM)

....

19

B.3.


Irritation


eye (EpiOcular method)

................................
................................
................................
...

20

B.4. Genotoxicity


bacteria

................................
................................
................................
........................

21

A
PPENDIX
C:

E
NVIRONMENTAL
F
ATE AND
E
COTOXICOLOGICAL
I
NVESTIGATION
S

................................
...............

22

C.1.

Environmental Fate

................................
................................
................................
.......................

22

C.1.1.

Ready biodegradability (1)

................................
................................
................................
.......

22

C.1.2.

Bioaccumulation

................................
................................
................................
......................

22

C.1.3.

Ready biodegradability (2)

................................
................................
................................
.......

22

C.2.

Ecotoxicological Investigations

................................
................................
................................
....

23

C.2.1.

Acute toxicity to fish

................................
................................
................................
................

23

C.2.2.

Acute toxicity to aquatic invertebrates

................................
................................
.....................

24

C.2.3.

Algal growth inhibition test

................................
................................
................................
.....

24

B
IBLIOGRAPHY

................................
................................
................................
................................
......................

26



December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
3

of
27


F
ULL
P
UBLIC
R
EPORT

This assessment report is for an exten
sion of
the
original assessment certificate for
Sodium Laurylglucosides

Hydroxypropylsulfonate
. Based on the submission of new information by the extension notifier, some sections
of the original assessment report for
Albright & Wilson Pty
Ltd have

been modified. These modifications have
been made under the heading
‘Extension Application’

in the respective sections.


SUMMARY


The following details will be published in the NICNAS
Chemical Gazette:


ASSESSMENT
REFERENCE

APPLICANT

CHEMICAL OR TRADE
NAME

HAZARDOUS
SUBSTANCE

INTRODUCTION
VOLUME

USE

EX/178
(STD/1331)

Capitol
Ingredients

Australia Pty Ltd

Sodium
Laurylglucosides

Hydroxypropylsulfonate

Yes

1
0
0

tonne
s

per
annum

A c
omponent of
personal care

products
and surface
cleaning products


Hazard classification

The notified chemical is not able to be classified as hazardous under the
Approved Criteria for Classifying
Hazardous Substances
(
NOHSC, 2004). However, based on the reported irritation effects of structurally related
chemicals (APGs and sulfonates) as irritating to the eyes and skin (R36/38), the notified chemical should be
considered as though classified as:


R36/38 Irritating to e
yes and skin.


and


As a comparison only, the classification of the notified chemical using the Globally Harmonised System for the
Classification and Labelling of Chemicals (GHS) (United Nations 2003) is presented below. This system is not
mandated in
Australia and carries no legal status but is presented for information purposes.




Hazard category

Hazard statement

Acute aquatic toxicity

2

Toxic to aquatic life.



Human health risk assessment

Under the conditions of the occupational settings
described, the notified chemical is not considered to pose an
unacceptable risk to the health of workers.


When used in the proposed manner, the notified chemical is not considered to pose an unacceptable risk to
public health.


Environmental risk assessm
ent

On the basis of the PEC/PNEC ratio and the reported use pattern, the notified chemical is not considered to pose
a
n unreasonable

risk to the environment.


Risk assessment relating to extension applicant

The use and environmental fate described in the e
xtension application are not expected to impact
the outcomes
of

the original human health and environment risk assessment and recommendations.


December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
4

of
27

Recommendations


R
EGULATORY
C
ONTROLS

Hazard Classification and Labelling




The introducers of the notified
chemical should consider the following health hazard classification:



R36/38: Irritating to eyes and skin




Use the following risk phrases for products/mixtures containing the notified chemical:



>

20%: R36/38: Irritating to eyes and skin



C
ONTROL
M
EASURES

O
ccupational Health and Safety




A person conducting a business or undertaking at a workplace should implement the following safe
work practices to minimise occupational exposure to the notified
chemical
:



Avoid contact with skin and eyes




A person conductin
g a business or undertaking at a workplace should ensure that the following personal
protective equipment is
used by workers to minimise occupational exposure to the notified chemical as
introduced at ≤ 40%:



Wear eye/face protection



Wear
impervious

gloves
,

c
overalls and enclosed footwear




Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.




The MSDS and label for the imported product containing the notified chemical at ≤

40% should be
revised to include the following risk phrases:



R36/38
:

Irritating to eyes and skin.




A copy of the MSDS should be easily accessible to employees




If products and mixtures containing the notified chemical are classified as hazardous to healt
h in
accordance with the
Approved Criteria for Classifying Hazardous Substances
[NOHSC:1008(2004)]
workplace practices and control procedures consistent with provisions of State and Territory hazardous
substances legislation must be in operation.


Disposal




The notified
chemical

should be disposed of to landfill


Storage




The following precautions should be taken regarding storage of the notified chemical:



Keep in a cool place away from strong oxidizing agents


Emergency procedures




Spills and/or accidental release of the notified
chemical

should be handled by physical containment,
collection and subsequent safe disposal.


Regulatory Obligations


Secondary Notification

This risk assessment is based on the information available at the time of notification. The Director may call for
the reassessment of the chemical under secondary notification provisions based on changes in certain
circumstances. Under Section 64 of the
In
dustrial Chemicals (Notification and Assessment) Act (1989)
the
December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
5

of
27

notifier, as well as any other importer or manufacturer of the notified chemical, have post
-
assessment regulatory
obligations to notify NICNAS when any of these circumstances change. These obl
igations apply even when the
notified chemical is listed on the Australian Inventory of Chemical Substances (AICS).


Therefore, the Director of NICNAS must be notified in writing within 28 days by the notifier, other importer or
manufacturer:


(1)

Under Se
ction 64(1) of the Act; if



the chemical is intended for use in consumer products at concentrations > 14%;



the chemical is intended for use in products that are not rinse
-
off

or


(2)

Under Section 64(2) of the Act; if



the function or use of the chemical ha
s changed from an anionic surfactant component of personal
care products and hard surface cleaning products at concentrations up to 14%, or is likely to change
significantly;



the amount of chemical being introduced has increased from
2
00 tonnes, or is like
ly to increase,
significantly;



the chemical has begun to be manufactured in Australia;



additional information has become available to the person as to an adverse effect of the chemical
on occupational health and safety, public health, or the environment.


The Director will then decide whether a reassessment (i.e. a secondary notification and assessment) is required.


Material Safety Data Sheet

The MSDS of
the
product containing the notified chemical provided by the notifier was reviewed by NICNAS.
The accur
acy of the information on the MSDS remains the responsibility of the applicant.


Extension Application

The extension applicant has provided an MSDS
for

the notified chemical which was reviewed by NICNAS. The
accuracy of the information on the MSDS remains

the responsibility of the extension applicant.


ASSESSMENT DETAILS


Sodium Laurylglucosides Hydroxypropylsulfonate


1.

APPLICANT AND NOTIFICATION DETAILS


Holder of Original Assessment Certificate (
STD/1331
)

Albright & Wilson Pty Ltd (ABN 36 004 234 137)

295 Whitehall Street

YARRAVILLE

VIC

3013


Applicant for Extension of the Original Assessment Certificate

Capitol Ingredients Australia Pty Ltd (ABN
30 055 147 567
)


Unit 9, 7 Meridian Place


B
ELLA

V
ISTA


NSW
2153


N
OTIFICATION
C
ATEGORY

Standard:
Chemical other than polymer (more than 1 tonne per year).


E
XEMPT
I
NFORMATION
(S
ECTION
75

OF THE
A
CT
)

No details are claimed exempt from publication.




December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
6

of
27

V
ARIATION OF
D
ATA
R
EQUIREMENTS
(S
ECTION
24

OF THE
A
CT
)

Variation to the schedule of data requirements is claimed as follows:

v
apour
p
ressure,
h
ydrolysis as a function of pH,
p
artition
c
oefficient,
a
dsorption/
desorption, acute d
ermal
t
oxicity,
a
cute
i
nhalation
t
oxicity,
skin i
rritation,
e
ye
i
rritation,
s
kin
s
ensitisation,
repeated d
ose
toxicity,
c
hromo
some
d
amage and
b
ioaccumulation.


N
OTIFICATION IN
O
THER
C
OUNTRIES

USA (2007)


2.

IDENTITY OF CHEMICAL


M
ARKETING
N
AME
(
S
)

Suga*Nate 160
(
≤ 40%

so汵瑩on of no瑩f楥i 捨em楣慬i

卯d極m iaurylglu捯s楤敳e
eydroxypropylsu汦on慴攠Ef乃f 乡m攩


C
HEMICAL
N
AME

D
-
Glucopyranose, oligomeric, C10
-
16
-
alkyl glycosides, 2
-
hydroxy
-
3
-
sulfopropyl ethers, sodium salts


CAS

N
UMBER

742087
-
49
-
6


M
OLECULAR
F
ORMULA

Unspecified


S
TRUCTURAL
F
ORMULA



M
OLECULAR
W
EIGHT
*



508 Da.

* Assumes R = C
12
H
25

and n = 1


A
NALYTICAL
D
ATA



M
ETHOD

Infra
-
red Spectrometry

Remarks

Major peaks at: ~
3400, 1600, 1000 and 700 cm
-
1


3.

COMPOSITION


D
EGREE OF
P
URITY

>

94
%




December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
7

of
27

K
NOWN
H
AZARDOUS
I
MPURITIES



Chemical Name

D
-
Glucopyranose, oligomeric, C
10
-
16
-
alkyl glycosides

CAS No.

110615
-
47
-
9

Weight %

1.72%

Hazardous Properties

≥ 20% Xi; R36/38 Irritating

瑯 敹esLskin.

Chemical Name

Alcohols, C
10
-
16

CAS No.

67762
-
41
-
8

Weight %

< 0.5%

Hazardous Properties

≥ 20% Xi; R36/38 Irritating to eyes/skin.


f
MPURITIES
(>

1% by weight)




Chemical Name

Sodium
chloride

CAS No.

7647
-
14
-
5

Weight %

3.3%



4.

PHYSICAL AND CHEMICAL PROPERTIES


Appearance of the notified chemical: Soft, yellowish, waxy solid.

Appearance
of the product Suga*Nate 160 containing the notified chemical at
≤ 40%

慴aOM


C 慮d

101.3 k愺a
C汥慲 y敬汯w vis捯us 汩lu楤
.

Th攠fo汬lwing v慬ues 慲攠for 瑨攠produ捴c卵ga*乡瑥 160 捯n瑡楮ing h攠no瑩f楥i 捨emi捡氠慴a
≤ 40%

un汥ss
o瑨敲w楳攠s瑡瑥t.


Property

Value

Data Source/Justification

Melting Point/Freezing Point

250




Es瑩ma瑥

for no瑩f楥i 捨em楣慬

Bo楬楮g o楮

㄰1


C

Es瑩ma瑥

䑥Dsiy

ㄱ㌰

kg/m
3

Measured

Vapour Pressure

Not determined

The notified chemical will not be
isolated from solution which has a
vapour pressure similar to water.

Water Solubility

816 g/L at 20


C

䵥慳ar敤

Hydrolysis 慳⁡ Func瑩n of p䠠

却慢汥

䵓䑓

慲瑩瑩on Co敦f楣楥n琠


-
o捴cno氯w慴敲)

Ep散瑥 瑯 b攠汯w, b慳敤 on he
w慴敲 solub楬楴y.

Th攠 proper瑹 捡nno琠 b攠 m敡sur敤 as
瑨攠no瑩f楥i 捨em楣慬iis 愠surf慣瑡琮

Adsorp瑩n⽄/sorp瑩n

卯rp瑩n 瑯
so楬i楳 數p散瑥 瑯 be
w敡k.

Th攠no瑩楥i 捨em楣慬iis highly w慴敲
so汵b汥l

䑩Dso捩慴楯n Cons瑡n

䙵汬y d楳so捩慴cd 楮 慱u敯us
so汵瑩n.

卵lfon楣 慣楤s 慲e s瑲ong 慣楤s
(m整ean敳ulfon楣i慣楤 p䭡K縠
-
3).

噩V捯s楴y

6900 cps 慴a25


C

䵥慳ar敤

p䠠慴a10┠
捯n捥n瑲慴楯n


3

M
敡sur敤

䙬慳h o楮

㸠93


C

䵥慳ar敤

䙬Fmm慢楬楴y

乯琠p散瑥 瑯 b攠f污mm慢汥

Es瑩ma瑥

䅵瑯ign楴楯n Temp敲慴are

乯琠p散瑥 瑯 慵瑯楧in楴i

Es瑩ma瑥

Ep汯s楶攠rop敲瑩敳

乯琠p散瑥 瑯 b攠數p汯s楶e

䑯敳o琠on瑡n 數p汯sophor敳


D
ISCUSSION OF
P
ROPERTIES


For full details of tests on physical and chemical properties, please refer to Appendix A.


Reactivity

May react at high temperatures or in the presence of strong oxidizing agents.


Physical hazard classification

Based on the submitted physico
-
chemical data depicted in the above table, the notified
chemica
l

is not
recommended for hazard classification according to the
Globally Harmonised System for the Classification and
Labelling of Chemicals (GHS),
as adopted for

industrial chemicals

in Australia
.


5.

INTRODUCTION AND USE INFORMATION


December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
8

of
27

M
ODE OF
I
NTRODUCTION OF
N
OTIFIED
C
HEMICAL
(100%)

O
VER
N
EXT
5

Y
EARS

The notified chemical will be imported
at
≤ 40%

in t
he product Suga*Nate 160 in 200

L

drums for
reformulation.


M
AXIMUM
I
NTRODUCTION
V
OLUME OF
N
OTIFIED
C
HEMICAL
(100%)

O
VER
N
EXT
5

Y
EARS


Original Notifier

Year

1

2

3

4

5

Tonnes

10


100

10


100

10


100

10


100

10


100


Extension Applica
tion

Year

1

2

3

4

5

Tonnes

10


100

10


100

10


100

10


100

10


100


Total Import Volume

Year

1

2

3

4

5

Tonnes

2
0


2
00

2
0


2
00

2
0


2
00

2
0


2
00

2
0


2
00


P
ORT OF
E
NTRY

Sydney, Melbourne, Brisbane


I
DENTITY OF
R
ECIPIENTS


The notified chemical will be manufactured by Colonial Chemicals, Inc., 225 Colonial Drive, South Pittsburg,
TN 37380 USA

and imported into Australia by
Albright & Wilson

(
Australia
)

Limited.


Extension Application

The notified chemical will be manufacture
d by Colonial Chemicals, Inc., 225 Colonial Drive, South Pittsburg,
TN 37380 USA and imported into Australia by Capitol Ingredients Australia Pty Limited.


T
RANSPORTATION AND
P
ACKAGING

The notified chemical will be imported as a component of the product
Suga*Nate 160 in 200 L steel drums
before being transported to
various

customers across Australia for reformulation into
personal care

products

and industrial cleaners in packages ranging up to 500 mL in size
for sale in various stores and outlets.


U
SE


The notified chemical will be used as an anionic surfactant component of personal care products and
hard
surface
cleaning products

at concentrations up to
1
4
%.


O
PERATION DESCRIPTION



Reformulation

The notified chemical will be imported as an aqueous solution (containing
≤ 40%

no瑩t楥i 捨em楣慬i. f琠wi汬lbe
瑲慮spor瑥t 瑯 愠r敦ormu污瑩ln s楴攠wh敲攠楴iw楬氠b攠w敩gh敤 慮d 慤d敤 瑯 愠b汥ld楮g 瑡tk w楴h oth敲 楮gr敤楥i瑳

for
formu污瑩ln in瑯 fin楳h敤 pr
odu捴c


卡pp汩ng and qu慬aty 捯n瑲o氠瑥獴ing of th攠formu污瑥l produ捴cw楬氠b攠
捯ndu捴敤 pr楯r 瑯 p慣k慧ing. Th攠f楮楳h敤 produ捴cw楬氠then b攠瑲慮sf敲r敤 in瑯 produ捴c捯n瑡楮敲s

wh楣i w楬i
b攠
s敡汥l
慮d p慣k慧敤 for r整慩氠s慬a



End
-
use

Personal care p
roducts contai
ning the notified chemical (≤
N
4
┩Bsu捨 慳aso慰sI d整敲gen瑳 慮d

shampoos w楬氠
b攠us敤 d慩ay in h慩a and b敡uty s慬ans and by
memb敲s of 瑨攠pub汩挮
Th攠no瑩f楥i 捨emi捡氠wi汬l慬獯 b攠use
d

by 捬敡n敲s

in hard surface cleaners at ≤
N

.




December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
9

of
27

6.

HUMAN HEALTH IMPLICATIONS


6.1

Exposure assessment


6.1.1

Occupational exposure


N
UMBER AND
C
ATEGORY OF
W
ORKERS


Category of Worker

Number

Exposure Duration
(
hrs
/day)

Exposure Frequency
(days/year)

Transport

1
-
2

1

4
-
6

Storage

1

1

4
-
6

Reformulation

1
-
3

0.5

4
-
6

Laboratory Technician

1

0.5

4
-
6


E
XPOSURE
D
ETAILS

Transport and Storage

Exposure to the notified chemical during transport and storage is not anticipated except in case of an accident
leading to release.


Ref
ormulation

Accidental dermal and
ocular exposure to drips, spills and splashe
s of the notified chemical (
≤ 40%
) may o捣ur
dur楮g we楧hingI ch慲ging of mixing v敳s敬猬e b汥nd楮gI qu慬楴y assur慮捥 瑥t瑩tg 慮d f楬汩ng of produ捴
p慣k慧ing.
䑥am慬aand o捵污r 數posur攠may 慬獯 o捣ur dur楮g 捬c
an楮g and wash楮g of 敱u楰men琠us敤 楮
r敦ormu污瑩ln wi瑨 慰propr楡瑥i so汶敮瑳.
Th攠no瑩f楥i s瑡瑥s 數posur攠楳 exp散瑥t 瑯 b攠
minim楳敤

g楶en th攠
慮瑩捩t慴敤 us攠of 捬cs敤 systems for r敦ormu污瑩ln 慮d p敲son慬apro瑥捴楶攠敱u楰men琠Emmb)I su捨 慳as慦整

g
ogg汥猬limp敲v楯us g汯v敳Ⱐov敲慬汳 and 敮捬cs敤 footw敡r.



fnh慬慴楯n 數posur攠瑯 慥roso汳 楳
no琠txp散瑥t du攠瑯 瑨攠慮瑩捩t慴敤 h楧h v楳捯s楴y of 卵gaG乡瑥 NSM



Use of finished
personal care

products

Occupational exposure is possible for workers in
hair and beauty salons using products contai
ning the notified
chemical (≤
N
4
┩B 䑥am慬a數posur攠楳 數p散瑥t 瑯 be 數瑥ts楶攠g楶en 瑨慴ashampoo 慮d
p敲son慬a捡r攠produ捴c

捯n瑡楮ing th攠no瑩f楥i 捨emi捡氠wi汬lb攠慰p汩敤 d楲散瑬t 瑯 瑨攠skin

慮d h慩a
. A捣楤e
n瑡t o捵污l 數posur攠and
or慬a楮g敳e楯n may 慬so o捣ur.


A汴hough th攠汥v敬eand rou瑥tof 數posur攠w楬氠v慲y d数敮ding on th攠m整eod of 慰p汩捡瑩on 慮d work pr慣瑩捥t
emp汯y敤I 數瑥ns楶攠d敲m慬aexposur攠is 數p散瑥t in som攠o捣up慴楯n慬ase瑴楮gs. Th楳 expos
ur攠楳 汩k敬y 瑯 b攠
gr敡瑥t 瑨an 瑨慴aexp散瑥t for 瑨攠pub汩挠Es敥 b敬ew).


Use of hard surface cleaners

Workers

using hard surface cleaning products containing the notified chemical
(≤
4
┩B 慲攠 數p散瑥t 瑯
數p敲楥i捥 數瑥ns楶攠d敲m慬aexposure

dur楮g 慰p汩l
慴楯n of 瑨攠produ捴猠慮d r楮sing
. A捣楤敮瑡氠ey攠數posur攠
瑯 慥roso汳 of 瑨攠produ捴c
i
s 慬獯 poss楢汥

dur楮g 捬敡ning
.

䝬dv敳emay b攠worn wh敮 h慮d汩ng 瑨攠捬敡n楮g
so汵瑩tn bu琠ty攠pro瑥捴楯n is unl楫敬y 瑯 b攠us敤.


6.1.2.

Public exposure

Public
exposure to the notified chemical is expected to be widespread and frequent through daily use of
personal care products containing the notified che
mical at concentrations up to
1
4
%. Exposure to the notified
chemical will vary depending on individual use pa
tterns. The principal route of exposure will be dermal, while
ocular and inhalation exposure is also possible, particularly if products are applied by spray. Accidental
ingestion from the use of these types of products is also possible from facial use.


Public exposure to the notified chemical in Australia has been estimated using the Scientific Committee on
Consumer Products’ (SCCP’s) Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety
Evaluation and applying the following assumpti
ons:


-

Bodyweight of 60 kg for females (SCCP, 2006);

-

The concentration of the notified chemical in all cosmetic and household products is 14%;

-

100% dermal absorption (SCCP, 2006);

December 2012

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Page
10

of
27

-

An individual uses all product types containing the notified chemical.


Prod
uct(s) used

Use level for each product

Retention
factor

Systemic Exposure


(mg/kg bw/day)

Facial cleanser

0.8 g x 0.5 applications/day

0.01

0.07

Shampoo

10.46 g per day

0.01

1.74

Conditioner

14.00 g x 0.28 applications/day

0.01

0.65

Shower gel

5.00 g x

2 applications/day

0.01

1.67

Laundry detergent
(
1
)

230 g x 1 use/day

0.00095

3.64

Dishwashing liquid
(
1
)

5.34

m
g
(
2
)

x 3 uses/day

1.0

0.2
7

Liquid soap
(
1
)

1.6 g x 7 applications/day

0.005

0.93

Total product exposure =



8.97


Total exposure to the
notified chemical at 14% in each of the products above = 8.9
7

mg/kg bw/day x 14%





Total



1.2
6

(
1
)

Exposure estimates by the Soap & Detergent Association’s (SDA) (2005).

(
2
)

Amount in contact with skin per use


This exposure estimate was produced using highly conservative assumptions and is expected to reflect a worst
-
case scenario. In reality, the level of exposure is expected to be lower
than 1.
2
6

mg
/kg bw/day as it is assumed
that consumers would not use all t
hese products to the extent shown above, and dermal absorption may be less
than 100%.


6.2.

Human health effects assessment


A summary of the

results from toxicological investigations conducted on the notified chemical

and

structurally
related
chemicals: A
lkyl polyglucosides

(APGs)
, Secondary alkane sulfonates
(SAS)
(CAS No. 68037
-
49
-
0)
and Linear alkylbenzene sulphates

(LAS)

(CAS No. 68411
-
30
-
3, CAS No. 1322
-
98
-
1, 25155
-
30
-
0, CAS No.
90194
-
45
-
9, CAS No. 85117
-
50
-
6)
are summarised in

Table 1
below. Details
of
studies on the notified
chemical

can be found in Appendix B.


December 2012

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11

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27

Table 1: Physico
-
chemical and toxicological properties of the notified chemical and 3
structurally related
chemicals


Endpoint

Notified chemical
1

(CAS No. 742087
-
49
-
6)

Alkyl
Polyglucosides
(APGs)
2

Secondary Alkane Sulfonate
(SAS)
3

(CAS No. 68037
-
49
-
0)

Linear Alkylbenzene Sulpohonate (LAS)
4

(CAS No. 68411
-
30
-
3, CAS No. 1322
-
98
-
1,
25155
-
30
-
0, CAS No. 90194
-
45
-
9, CAS No.
85117
-
50
-
6)

Molecular weight (Da.)

508****

~ 334*

328**

342.4***

Melting point/Freezing Point (
o
C)

250

-

10
5

< 200

277 (C
12
)

Boiling
point (
o
C)

105

100
5

-

637^

Density (kg/m
3
)

1130

1050


1150
5

-

1060

Vapour pressure at 20
o
C (kPa)

-

-

5.3x10
-
14
^^

3
-
17x10
-
16
^

Water solubility

816

Water
-
soluble
5

350

250

Log K
OW

-

-

2.76

3.32 (ave.)

Rat, acute oral toxicity (LD50) (mg/kg bw)

> 2000

>
2000

2130 (M), 2890 (F)

≥ 1086
-

1980

Rabbit, acute dermal toxicity (LD50) (mg/kg bw)

-

> 2000

-

> 1000

Rat, acute inhalation toxicity (LD50) (mg/kg bw)

-

-

-

-

Rabbit, skin irritation

-

R38 at ≥ 40%

R38 at ≥ 30%

R38 at 5
-

47%

Skin irritation


human
volunteers

non
-
irritating at
4%

-

-

-

Rabbit, eye irritation


R36 at ≥ 50%

R36 at ≥ 30%

R36 at 5
-

47%

Hen’s Egg Test


Chorio
-
allantoic Membrane (HET
-
CAM)

non
-
irritating at
2%

-

-

-

In vitro eye irritation


EpiOcular Test

non
-
irritating at
0.8
%

-

-

-

Guinea pig, skin sensitisation


Magnusson &
Kligman or Buehler Method

-

Not sensitising at
≤ 20%

Not sensitising at ≤ 60%

Not sensitising at ≤ 6.5%

Rat, Repeat dose oral toxicity (mg/kg bw/day)

-

90 days, NOAEL
= 1000

52 weeks,
NOEL = 200

9 months, NOAEL = 85

LOAEL = 145

Rat, Repeat dose dermal toxicity

-

-

4
-
5 weeks, NOAEL = 32% conc.

15 days, LOAEL = 286 mg/kg bw/day

Genotoxicity


bacterial reverse mutation test

negative

negative

negative

negative

Genotoxicity


In vitro (
Chromosome aberration test)

-

negative

-

-

Genotoxicity


In vivo

-

-

negative

negative

1

See section 6.2 Human health effects assessment and Appendices A and B for details. **** Assumes R = C
12
H
25

and n = 1

2

Detergency of Specialty Surfactants (2001).

3

HERA (2005)


4

HERA (2007)

5

MSDS for Alkylpolyglucoside (CAS No. 68515
-
73
-
1) available online [6 July 2009]:
www.trade
-
chem.com/products/MSDS/APG%20MSDS.pdf

^
Calculated for C
12

^^ Calculated for C
16

** Average molecular weight

*** Calculated based on an average C
11.6

linear alkyl chain
December 2012

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12

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27


Toxicokineti
cs, metabolism and distribution

Limited data is available to describe the likely toxicokinetic

properties of the notified chemical. Given its high
water solubility and molecular weight of <
10
00

Da., absorption might be expected following ingestion, or
inhalation exposure (EC, 2003). Studies on
LAS
indicated ready absorption
(
80
-
90%) via the gastro
intestinal
tract
and

distribution to most organs except the uterus
. Limited information indicates
LAS
have

limited dermal
absorption (HERA, 2007). It is unknown to what extent the differences in structure between
LAS
and the
notified chemical have on its t
oxicokinetics.
However, the metabolism of the notified chemical is thought to be
markedly different to
LAS
due to the presence of an aromatic ring in the latter.


Acute toxicity

A formulation containing the notified chemical at a concentration of 36.2%
was

found to be of low acute oral
toxicity

(LD50 >
742
mg/kg bw/day)

in 5 female rats according to the method described by OECD TG 420
A
cute Oral Toxicity
-

Fixed Dose Method

(
Con
sumer Product Testing Co., 2008
).



The notified chemical was not tested for acu
te toxicity via the dermal or inhalation routes.

However, acute
dermal toxicity studies on structurally related chemicals:
APGs

(LD50 > 2000) and LAS (LD50 >

1000) indicate
that the notified chemical is unlikely to be toxic following acute dermal exposure. The acute inhalation toxicity
potential of the notified chemical is unknown.


Irritation and Sensitisation

The notified chemical was not tested for skin or
eye irritation at concentrations greater than 4%. However, tests
on rabbits using
structurally related
chemicals resulted in irritant effects sufficient for classification with R36/38
Irritating to eyes and skin (see Table 1).

Based on this information, th
e notified chemical may be considered as
irritating to the eyes and skin.


A 48
-
hour
semi
-
occlusive patch test
to determine the potential for skin irritation in human volunteers was
conducted
using
0.2 mL of
a
solution diluted to a concentration of
4% noti
fied chemical

in

distilled

water.
T
he
treated skin sites
of 53 adult volunteers (11 Males, 42 Females)
were observed for signs of irritation

48
hrs

and
72
hrs

after application.
No signs of irritation were observed in any of the test subjects at either of
the
observation points

(see Appendix B for details)
.

Based on the results of the patch test in human volunteers using
the notified chemical at 4%, the notified chemical is not considered to be irritating at ≤ 4% in surfactant
捯n瑡楮ing formu污瑩tns.


Th攠
eye irritation potential of dilute solutions of the notified chemical was investigated in a Hen’s Egg Test
J
Chor楯慬污a瑯楣i 䵥mbr慮攠 E䡅T
J
CA䴩 慳aay. A

solu瑩tn
EM.P mi)
of
瑨攠 no瑩f楥i 捨em楣慬i d楬i瑥t 瑯 愠
捯n捥n瑲慴楯n of O┠
楮 d
楳瑩汬敤
w慴敲
I

was 慰p汩敤 瑯 瑨攠捨or楯
J
慬污n瑯楣i membr慮攠of
4

Leghorn hens’ eggs
慣捯rd楮g 瑯 a

modif楣慴楯n of 瑨e me瑨od d敳捲楢敤 by 䭥mp敲 慮d iu数k攠ENVUS).

乯 s楧ns
楮d楣慴iv攠
of
hyp敲慥m楡i h慥morrh慧攠or 捯慧u污瑩ln w敲攠obs敲v敤 楮 慮y of 瑨攠membran敳e瑥s瑥
d. Th敲敦or攬
瑨攠no瑩t楥i
捨em楣慬i慴aO
B

w慳ano琠tonsid敲敤 慮 敹攠楲r楴in琠tnd敲 瑨攠捯nd楴楯ns of th攠瑥st

Es敥 App敮d楸 B for d整慩汳e
.


Th攠䡅T
J
CA䴠assay has no琠ye琠b敥n v慬楤慴敤 慳a愠rep污捥m敮琠瑥獴 for 瑨攠
in vivo

Draize

test, however
validation of this assay is currently being considered by the US
National Toxicology Program Interagency
Center for the Evaluation of Alternative Toxicological Methods and the Interagency Coordinating Committee on
the Validation of Alternati
ve Methods

(
NICEATM
-
ICCVAM
)
.
The draft ICCVAM recommendations from this
validation process were released in April 2009 and recommended that the Hen’s Egg Test
J
Chor楯慬污a瑯楣i
䵥mbr慮攠E䡅T
J
CA䴩 no琠b攠us敤 for r敧u污瑯ry h慺慲d 捬慳cif楣慴楯n purpos敳eb慳a
d on 愠污捫 of 慤敱u慴a
d慴愠EfCCsA䴬 OMMV
a
).
T
h攠
dr慦琠r散ommend慴楯ns 慬獯 楮捬cd敤 愠r散ommend慴楯n th慴a瑨攠
䡅T
J
CA䴠瑥t琠
m整hod 捯u汤 b攠 us敦u氠 for 捥r瑡楮 subs瑡n捥s such as 瑨攠 no瑩f楥i 捨em楣i氠 楮 formu污瑩lns 慴a 汯w
捯n捥n瑲慴楯ns:


“Based on an an
慬ys楳 of SM 捯mpounds EOR surf慣瑡tt b慳敤 formu污瑩tnsI NU o楬⽷慴敲 emu汳楯ns and
NT楮d楶楤u慬asubs瑡n捥s)I th攠䡅T
J
CA䴠f匨p) 瑥t琠m整hod 捡n b攠us敤 慳a愠s捲敥ning 瑥st 瑯 楤敮瑩晹 subs瑡n捥s
慳ano琠污l敬汥e as 楲r楴慮ts from 慬氠oth敲 h慺慲d 捡瑥tor楥
s EoPS or o4N). Th楳 r散omm敮d慴楯n is 汩m楴敤 瑯
cosmetic and personal care formulations that are oil/water emulsions or surfactant containing formulations.”



䡯wev敲I
慴ath敩e r散en琠m敥瑩ng th攠
fnd数敮den琠卣楥p瑩晩t m敥r o敶楥w m慮el

EfCCsAMI OMMVb) d
楤 no琠慧r敥
w楴h
慬氠
th攠dr慦琠t散ommend慴楯ns pu琠forw慲d by fCCs䅍
:


“The Panel did not support the ICCVAM draft recommendation (with one minority opinion)

瑨慴ab慳敤 on th攠
December 2012

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Page
13

of
27

available data, the HET
-
CAM IS(A) test method can be used as a screening test
to identify substances as not
labelled as irritants from all other hazard categories when results are to be used for EU or GHS hazard
classifications. The Panel concluded that there were too few surfactants or oil/water emulsions in the mild to
moderate ir
ritant categories to have sufficient confidence in the ability of the test to distinguish them from the
not labelled as irritant category.




Therefore the validity of the HET
-
CAM assay for determining the irritancy potential for a chemical or
formulation
has not yet been confirmed. However given the complete absence of response in the HET
-
CAM
assay for the notified chemical solution, and the tendency for the HET
-
CAM assay to over
-
predict the irritancy
potential in the validation studies of surfactant formu
lations, it is
likely that the HET
-
CAM results indicate a low
irritancy potential for the
notified chemical at a concentration of 2%
.



An
in vitro
eye irritation test was performed on
a solution
of the notified chemical diluted to 0
.8
%

using the
EpiOcular

Tissue Model (see Appendix B for details). This test
method
is not a validated alternative to the
in
vivo
animal test, although
efforts towards validation are underway
.
The test method protocol used for the notified
chemical solution varies from the metho
d currently undergoing validation (Harbell et al, 2009). The EpiOcular
Tissue Model
has previously been shown to provide information on the ocular irritation potential of a cosmetic
ingredient (Stern et al 1998; Sheasgreen et al 2003). The
study author
s co
ncluded that the notified chemical did
not elicit any signs of irritancy

at the concentration tested
under the conditions of the test
, as there was
only
minimal
reduction in cell viability after
4 hours
treatment with

the notified chemical.


Therefore alth
ough the notified chemical itself is considered to be an eye irritant, based on consideration of the
data from the
in vitro

studies, in which no or very minimal irritancy responses were observed,
dilute solutions of
the notified chemical are unlikely to ca
use significant eye irritation.


The notified chemical does not contain any structural alerts for skin sensitisation (Barratt
et al
, 1994).
In
addition
, information on structur
ally
related
chemicals indicate

the potential for skin

sensitisation is unlikely

(see
Table 1)
.


Repeated Dose Toxicity

The notified chemical was not tested for r
epeated dose toxicity. I
nformation

on
chemicals with glucoside
functionality
suggests

this functional group i
s unlikely to cause toxicity following
repeated oral exposure
.


Information provided by the notifier on the chemicals with sulfonate functionality indicates that the systemic
toxicity following repeated exposure is varied, depending on the other functional groups within the molecules. In
studie
s on LAS, which contains an aromatic group and was shown to be rapidly metabolised to sulfophenyl
carboxylic acids, possible adverse effects on the liver and kidneys were observed. A NOAEL of 85 mg/kg
bw/day was suggested based on the weight of evidence fr
om a number of studies (HERA, 2007). However,
given the absence of aromatic groups in the notified chemical, and therefore the different metabolite profiles
expected, the relevance of these results
on LAS
to the systemic toxicity of the notified chemical i
s questionable.


In studies on SAS, which contains alkyl groups, unspecific effects (impaired grooming activity and retarded
weight gain) were seen at the highest dose tested in a feeding study (HERA, 2005). The NOAEL from this study
was estimated to be 20
0 mg/kg bw/day. No information was provided on the metabolism of SAS.


No conclusion can be made on the systemic toxicity of the notified chemical. However, b
ased on
the information
provided on structurally related chemicals it is unlikely to be a
significant toxicant after repeated systemic
exposure.


Mutagenicity

and Genotoxicity

The notified chemical was found
not
to

be mutagenic up to the levels of cytotoxicity in a bacterial reverse
mutation

assay conducted according to OECD TG 471 (see Appendi
x B for further details).


No data is available on the
potential for the notified chemical to cause chromosome aberrations
in vitro
.
However, there was no evidence of genotoxic
ity

or carcinogenicity

in studies on APGs (Friedli
, F., 2001), SAS
(HERA, 2005) and LAS (HERA, 2007).


Based on this information, the notified chemical i
s not expected to be genotoxic

or carcinogen.


December 2012

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FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
14

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27

Health hazard classification

B
ased on the reported irritation effects of
structurally related chemicals
(APGs and sulfonates)

as irritating to the
eyes and skin (R36/38), the notified chemical should be considered as
if it is classified as R36/38: I
rritating to
eyes and skin.


6.3.

Human health risk characterisation


6.3.1.

Occupational health and safety

Reformulation

Based on the available data, the
main concern for human health following exposure to the notified chemical is
eye and skin irritation.
The concentration cut
-
off level

for mixtures containing
eye
and skin
irritants is

>

2
0%
for classification
as R36
/
38
:

Irritating to eyes and skin

(NOHSC, 2004). This cut
-
off level

would
be considered
to
apply to the no
tified chemical as imported (
≤ 40%

bu琠no琠楮 th攠formu污瑥t

p敲son慬a捡re

or h慲d
surf慣攠
捬敡n敲

products (≤
N
4
┩B


Tr慮spor琠慮d w慲ehous攠
work敲s 慮d
work敲s

invo汶敤 in
瑨攠
hand汩lg and
r敦ormu污瑩tn of th攠
impor瑥t
produ捴

楮瑯 p敲son慬a捡r攠or h慲d
J
surf慣攠捬敡n敲 produ捴c

慲攠數p散瑥t 瑯 b
攠慴a愠h楧h r楳k of
楲r楴慴楯n

fo汬lw楮g d楲散琠o捵污l or d敲m慬a exposure

䡯w敶敲I t
hes攠work敲s a
r攠exp散瑥t 瑯 w敡r mmb 楮捬cdingI
s慦整y g污獳es or f慣攠sh楥汤I ov敲慬汳I rubb敲 g汯v敳e慮d en捬cs敤 footw敡r wh楣h 楳 慮t楣楰慴敤 瑯 minim楳攠
數posure
.

Th敲敦or攠th攠r楳k of s楧nif楣in琠楲r楴慴楯n eff散瑳 in th敳e work敲s
w敡r楮g mmb
楳 no琠捯ns楤敲敤 t

b攠un慣捥p瑡t汥l


Quality assurance, maintenance and professional
use of personal care and hard surface cleaning products

L
aboratory technicians
,
maintenance worker
s

and e
nd
-
users working in the hair,

beauty and cleaning
industries will experience dermal and potentially
accidental
ocular exposure to

personal care or

hard surface
cleaning products
containing the notified chemical (≤
N
4┩
.

i
慢or慴ary 瑥thn楣楡ns and m慩n瑥tan捥 work敲s
慲攠數p散瑥t 瑯 we
慲 s慦ety g汯ves 慮d pos
s楢ly

ey攠pro瑥捴楯n 瑯 minim楳攠
瑨攠po瑥tt楡氠for 數posure

and
瑨敲敦or攠瑨攠risk of
楲r楴慴楯n

is 數p散瑥t 瑯 b攠minim慬afor 瑨敳攠work敲s



Th攠use of
mmb
楳 not
捯ns楤敲敤 瑯 b攠捯mmon p污捥 for

work敲s using
p敲son慬 捡re

or 捬敡ning

produ捴c
捯n瑡楮ing th攠no瑩f楥i chem楣慬a
at ≤ 14%
in th攠h敡汴h and b敡uty


捬敡ning indus瑲楥i

慮d 瑨敲efor攠th敲攠is
som攠 r楳k of 楲r楴慴楯n
.

䡯w敶敲I 瑨e

r楳k 楳 no琠 捯ns楤er敤 瑯 b攠 unr敡son慢汥l b慳敤 on 瑨攠 fo汬lwing
m楴ig慴ang f慣瑯rs
:



EN)
A
琠㰠OM┠捯n捥n瑲慴楯nI 瑨攠produ捴猠wou汤 no琠b攠捬慳cif楥i 慳ask楮 or ey攠楲r楴慮瑳 慣捯rd楮g 瑯 瑨e
Approved Criteria for Classifying Hazardous Substances
(NOHSC, 2004).


(2)

The skin and eye irritation potential of the notified chemical was not tested at 14%.
However, chemicals
with the same functional groups, such as APGs and SAS were not found to be irritating at this concentration
indicating that

the notified
chemical is

un
likely

to present a significant risk o
f irritation at 14%
.


(3)
The
notified chemical will be used in rinse
-
off products such as shampoos and detergents. Therefore
,

the
concentration which workers
are likely to experience exposure is
assumed

to
be less th
an 14%. Tests on
diluted formulations

of the notified chemical

indicated that

significant

irritation is unlikely at low
concentrations
.
Based on these results, the notified chemical is not considered to present an unacceptable risk
once diluted

for use
.


A
lthough the irritation potential of the notified chemical is unknown at 14%,
it is not thought to present an
unreasonable risk to occupational health and safety when used in rinse
-
off products.



6.3.2.

Public health

Members of the public will experience

widespread and frequent exposure to the notified chemical through daily
use of personal care products (≤
N
4┩Bwh楣h w楬氠b攠慰p汩敤 d楲散瑬t 瑯 瑨攠skin and h慩a.
䙲cqu敮琠d敲m慬
exposure to cleaning products containing the notified chemical at ≤
N


楳 a
汳o 數p散瑥t.



Th攠汥l敬eof d敲m慬a慮d 慣捩c敮瑡氠o捵污l 數posur攠r敳e汴ing from 瑨攠慰p汩捡瑩ln of p敲son慬a捡r攠produ捴猠
containing the notified chemical (≤
N
4┩B瑯 瑨攠skin and h慩a
慮d 瑨攠us攠of 捬敡n楮g produ捴猠捯n瑡tning 瑨e
notified chemical at ≤

N4┠
楳 no琠數p散瑥t 瑯
汥慤 瑯

楲r楴慴楯n
for sim楬慲 r敡sons
瑯 瑨os攠
ou瑬楮敤 慢ov攠for
work敲s in 瑨攠h敡l瑨I b敡uty 慮d 捬敡n楮g 楮dus瑲楥献i 乡m敬y㨠
T
h攠produ捴猠wou汤 no琠b攠cons楤敲敤 瑯 be
捬慳cif楥i 慳ask楮 and ey攠楲r楴慮瑳㬠瑥獴s on chem楣慬猠wi瑨 th攠sam攠fun捴楯n慬agroups d楤 no琠楮d楣慴i 楲r楴慴楯n
December 2012

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Page
15

of
27

effects at that concentration
;

and the rinse
-
off nature of the products is thought to lead to exp
osure at lower
concentrations, shown not to be irritating in tests on
diluted formula
tions of the notified chemical.



The risk of eye exposure is thought to be greater for members of the public applying shampoos in the shower

compared to workers applying
shampoos standing up

in a hairdressing salon
. However,
the concentration of the
notified chemical that could enter the eye is thought to be less than 14% due to the rinse
-
off nature of
shampoos.
Although the potential for eye irritation cannot be ruled out
, at the diluted concentrations in use it is
unlikely to cause significant eye irritation.


A maximum systemic exposure of
1.2
6

mg/kg bw/day was estimated.
As no repeat dose toxicity studies have
been conducted, a NOAEL could not be established for the notified chemical. Therefore a quantitative risk
assessment cannot be conducted. However, given the expected low systemic toxicity after repeated use, the
noti
fied chemical is not expected to pose an unacceptable risk of systemic toxicity to the public when used in
personal care and cleaning
products at ≤
1
4%.

Overall, based on the available data, the notified chemical is not
considered to pose an unreasonable r
isk to public
health at concentrations up to
1
4
% in personal care

and
cleaning

products.


7.

ENVIRONMENTAL IMPLICATIONS


7.1.

Environmental Exposure & Fate Assessment


7.1.1

Environmental Exposure


R
ELEASE OF
C
HEMICAL AT
S
ITE

The notified chemical is manufactured overseas and imported as a

4M┠慱u敯us so汵t楯n for b汥ld楮g in瑯
fin楳h敤 produ捴献co敬敡s敳efrom b汥lding 慲攠數p散瑥t 瑯 b攠v敲y 汯w. bmpty drums 睩汬wb攠r楮s敤 慮d 瑨攠
慱u敯us rins慴攠us敤 for produ捴楯n. 印楬琠m
慴敲楡氠w楬氠b攠r散ov敲敤I or 捯n瑡楮敤 w楴i m慴敲楡氠such 慳asand
or 捡琠汩瑴敲 pr楯r 瑯 d楳pos慬a


o
ELEASE OF
C
HEMICAL FROM
U
SE

The notified chemical will be washed to sewer after use in personal care and cleaning products.


R
ELEASE OF
C
HEMICAL FROM
D
ISPOSAL

Spilt material will be disposed of to landfill as solid waste after containment as outlined above.


7.1.2

Environmental fate


The notified chemical is likely to pass through sewage treatment works and enter receiving waters as it is water
soluble. However, some degradation can be assumed, as the notified chemical is readily biodegradable, and a
portion may also partition to sludg
e as the notified chemical is surface active. The SimpleTreat model predicts
87% removal by biodegradation during sewage treatment. Residues discharged to waterways can be expected to
disperse and degrade. The notified chemical is not expected to bioaccumu
late in fish as it is water soluble and
readily biodegradable.


7.1.3

Predicted Environmental Concentration (PEC)


The PEC can be estimated as outlined below, with allowance for 87% removal during sewage treatment as
predicted by the SimpleTreat model.


Predicted Environmental Concentration (PEC) for the Aquatic Compartment

Total Annual Import/Manufactured Volume

100
,
000

kg/year

Proportion expected to be released to sewer

100%


Annual quantity of chemical released to sewer

100
,
000

kg/year

Days per
year where release occurs

365

days/year

Daily chemical release:

274

kg/day

Water use

200.0

L/person/day

Population of Australia (Millions)

21.374

million

Removal within STP

87%


Daily effluent production:

4,275

ML

December 2012

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Page
16

of
27

Dilution Factor
-

River

1.0


Dilution Factor
-

Ocean

10.0


PEC
-

River:

8.3


μg/L

PEC
-

Ocean:

0.83


μg/L



7.2.

Environmental effects assessment


The results from ecotoxicological investigations conducted on the notified chemical are summarised in the table
below. Details of
these studies can be found in Appendix C.


Endpoint

Result

Assessment Conclusion

Fish Toxicity

EC50 = 10.9 mg/L

Harmful

Daphnia Toxicity

LC50 = 6.5 mg/L

Toxic

Algal Toxicity

IC50 = 21.2 mg/L

Harmful


The fish test used imbalance rather than lethality as the endpoint. Results indicate that the notified chemical is
harmful to fish and green algae, and toxic to daphnids.


7.2.1

Predicted No
-
Effect Concentration


The PNEC can be determined by application

of an assessment factor of 100 to the most sensitive aquatic
toxicity endpoint, as data are available for three trophic levels.


Predicted No
-
Effect Concentration (PNEC) for the Aquatic Compartment

Daphnia toxicity

6.5

mg/L

Assessment Factor

100


PNEC:

65

μg/L



7.3.

Environmental risk assessment

The risk quotients (Q = PEC/PNEC) are tabulated below.


Risk Assessment

PEC μg/L

PNEC μg/L

n


J

oiv敲

U.P



0.13

Q
-

Ocean

0.83

65

0.01


The risk quotients are less than one, indicating that the
notified chemical is not expected to pose a risk to the
environment when it is used as proposed.


Extension Application

T
he proposed increase in volume under the extension application is not expected to impact on the current
environmental risk assessment.


December 2012

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FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
17

of
27

A
PPENDIX
A:

P
HYSICAL AND
C
HEMICAL
P
ROPERTIES


Melting Point

250








Remarks

Estimated

value of the
notified chemical provided by notifier.


Boiling Point

105


C





Rem慲ks

Es瑩ma瑥

v慬u攠of

h攠produ捴c卵ga*乡瑥 160 (
≤ 40%

no瑩t楥i chem楣慬i prov楤敤 by
no瑩晩tr


Density

1,130

kg/m
3




Method

Not provided


Remarks

Measurement of the product Suga*Nate 160 (
≤ 40%

no瑩ti敤 捨em楣慬i. T敳琠r数or琠not
prov楤敤.


Water Solubility

816 g/L at 20


C





䵥瑨od

佅C䐠T䜠105 W慴敲 卯汵b楬楴y.


Rem慲ks

䙬慳k 䵥hod. Th攠慱u敯us so汵瑩n w慳adr楥i 瑯 汥ls h慮 5┠w慴敲 in 愠捯nv散瑩n
ov敮 慴a90
o
C. The dried material was added periodically over a 30 day period until no
further
dissolution occurred. Solubility was determined by a gravimetric method after
centrifugation and drying as above.


Test Facility

Colonial Chemicals (
Undated
)


Hydrolysis as a Function of pH

Stable





Remarks

The shelf life of the 40% aqueous solution
as sold is in excess of 2 years, with a 12 month
guarantee of stability being offered to customers from the date of delivery.

Samples of the aqueous solution were acidified to pH 3 with concentrated sulfuric acid
and incubated on a boiling water batch for
12 or 24

hours. Recoveries as determined by
HPLC were between 99.3 and 102.4%.


Test Facility

Technical Consultancy Services (2009)


Partition Coefficient (n
-
octanol/water)

Not measured, but expected to be low.





Remarks

This property cannot be
measured because the notified chemical is a surfactant. It is
expected to be low, based on the high water solubility and ionic properties of the notified
chemical.


Adsorption/Desorption


Not measured, but expected to be low.





Remarks

The notified
chemical is expected to be mobile in soils based on its water solubility, but
may undergo some sorption because of its surface activity.


Dissociation Constant

pKa~
-
3





Remarks

The notified chemical is expected to be fully dissociated in aqueous solution by analogy
with the sodium salt of methanesulfonic acid.


Flash Point

> 93.3


C





䵥瑨od

敮sky
-
䵡r瑥s C汯s敤 Cup m整hod.


Rem慲ks

䵥慳arem敮琠on 瑨攠produ捴c卵ga*乡瑥
160 (
≤ 40%

no瑩ti敤 捨em楣慬i. T敳琠r数or琠not
prov楤敤.


pH

7
.3

December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
18

of
27





Method

Not provided


Remarks

Measurement on the product Suga*Nate 160 at 10% (4% notified chemical). Test report
not provided.


Viscosity

6900 cps at 25


C





䵥瑨od

乯琠
prov楤敤


Rem慲ks

䵥慳arem敮琠on 瑨攠produ捴c卵ga*乡瑥 160 (
≤ 40%

no瑩ti敤 捨em楣慬i. T敳琠r数or琠not
prov楤敤.

December 2012

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Page
19

of
27

A
PPENDIX
B:

T
OXICOLOGICAL
I
NVESTIGATIONS


B.1.

Skin Irritation in Human Volunteers



TEST

SUBSTANCE

SugaSulfonate

160 diluted to 10% concentration (4% notified chemical)




METHOD


Remarks
-

Method

The solution was diluted with distilled water to a concentration of 4% notified
chemical.
0.2 mL of the solution was applied to an absorbent pad (
2.54 cm x
2.54 cm) of a clear adhesive dressing and secured to the
upper back between the
scapulae of 53 healthy human volunteers (
11 Males, 42 Females
).

After 48
hrs
, the dressing was removed and the treated site examined for signs
of irritation. Another examination was conducted at 72
hrs

after application.




RESULTS


Remarks
-

Results

No
visible skin reactions

were observed in any of the 53 human subjects at the
48
-
hour or 72
-
hour time points.




CONCLUSION

The notified chemical was found not to be irritating in skin
at 4% concentration
under the conditions of the test.




TEST

FACILITY

Consumer Product Testing Co. (2004a)



B.2.

Irritation


eye

The Hen’s Egg Test


Utilizing the Chorioallantoic Membrane (HET
-
CAM)



TEST

SUBSTANCE

Colonial SugaSulfonate 160


NM┠ A捴cv攠 d楬i瑥t 瑯 RM┠ EO┠ no瑩t楥i
捨em楣慬i




䵅T䡏e

Hen’s Egg Test (HET)
J

Chor楯慬污a瑯楣i䵥mbr慮攠EC䅍) T敳琮eMod楦楣慴楯n
of 瑨慴ad敳捲楢敤 by 䭥mp敲 and iu数k攠ENVUS).

印散楥i

th楴攠ieghorn 捨楣ken 敧gs

乵mb敲 of eggs

4 for 敡捨
瑥獴 subs瑡n捥

佢s敲v慴楯n p敲楯d

o敡d楮gs 瑡k敮 慴aM.RI O 慮d R
m楮s

Tr敡瑭敮t

䅦瑥t 愠NM
J
day incub慴楯n 慴 PT.O

– N

C

楮 愠䭵h氠楮cub慴or
, 瑨攠sh敬氠ov敲 h攠
慩a s
慣a

of 敡捨 egg w慳aremov敤

and fo汬lwing hydr慴aon

for 2
-

m楮s
, he
楮n敲 membr慮攠w慳aremoved 瑯 r敶敡氠h攠C䅍.
A 0.3 mL 瑥s琠solu瑩n w慳
慤d敤 o 敡捨 CAM

for 愠 p敲楯d of
20 s散
s 慮d 敦f散瑳 of hyp敲em楡i
h慥morrhag攠(in捬cding m楮im慬ah慥morrhag攩 慮d 捯慧ul慴楯n w敲攠obs敲v敤
ov敲 愠p敲楯d of 5
mins

慮d s捯r敤 慣捯rd楮g 瑯 h攠maimum s捯r敳eshown in
瑨攠fo汬lwing 瑡汥l


Effect

Scores at time (min):

0.5

2

5

Hyperemia

5

3

1

Minimal
Hemorrhage
("Feathering")

7

5

3

Hemorrhage
(Obvious leakage)

9

7

5

Coagulation and/or
Thrombosis

11

9

7


Each reaction type can be recorded only once for each CAM, therefore the
maximum score per CAM

is 32. The mean score was determined for all
CAM’s similarly tested.


oem慲ks
J

䵥thod

乯 d整慩汳eof 瑥獴 subs瑡n捥 pr数慲慴楯n w慳ain捬ud敤.
Johnson’s Baby Shampoo
ERM┩B 慮d mr敬氠 卨ampoo Con捥n瑲慴攠 ERM┩B w敲攠 th攠 r敦敲敮捥 慲瑩捬ts
December 2012

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FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
20

of
27

included in the
study.





RESULTS




Test Solution

Average Irritation score

Colonial SugaSulfonate 160


10% Active
diluted to
50% concentration (2
% notified chemical)

0
.00

Johnson’s Baby Shampoo (50

%)

11.0
0

Prell Shampoo Concentrate (50%)

24.25



Remarks
-

Results

The study authors state that previous studies

have shown that the CAM of the
hen’s egg is
2 times
more sensi
tive to liquid irritants than

the rabbit eye.
Therefore, the

Colonial SugaSulfonate 160,

Johnson’s Baby Shampoo and the
Prell

Shampoo Concentrat
e
were tested
at
50% concentratio
n

to

equate to the
Draize results for
those substances at 100% concentration
.

The
Draft Updated
ICCVAM Recommended HET
-
CAM Test Method

Protocol

(available online [20 July 2009]:
http://iccvam.niehs.nih.gov/methods/ocutox/mildmod/HET
-
CAMProtocol11May09FD.pdf
) recommends testing
solutions undiluted unless
dilution is justified.





CONCLUSION

Under the conditions of this test, the notified
chemical

is predicted to be non
-
irritating to the ey
e at a concentration of
4
%.




TEST

FACILITY

Consumer Product Testing Co.

(2004b
)


B.3
.
Irritation


eye
(EpiOcular method)



T
EST
S
UBSTANCE

Colonial SugaSulfonate 160


NM┠A捴楶攠d楬u瑥t 瑯 OM┠EM.U┠no瑩t楥i
捨em楣慬i




M
ETHOD

EpiOcular Tissue Model (MatTek Corporation)
in vitro

colorimetric test
using MTT reduction.

Exposure
Period

20

min
s, 1 hr, 4 h
rs

Concentration

The test article ‘
Co汯n楡氠pug慓alfon慴攠NSM


NM┠Ac瑩te
’ was found to
h慶攠愠sp散楦楣igr慶楴y gr敡瑥t 瑨慮 M.VR gLmo氮lTh敲敦or攠楴 w慳

d楬i瑥t 瑯
OM┠BM.U┠Bo瑩t楥i 捨em楣i氩

pr楯r to dos楮g.

oem慲ks
J

䵥thod

䅳A 瑨攠 bp楏iu污l me瑨od h慳a no琠 ye琠 b敥n v慬楤慴敤 瑨敲攠 楳 no T敳e
䝵楤敬en攮 Th攠m整eod emp汯y敤 楮 th楳 s瑵dy w慳⁡s fo汬lws:

㄰〠

L of 瑨攠瑥獴 subs瑡n捥
(0.8
%

no瑩楥i 捨em楣慬i
, r敦敲敮捥 (Tr楴in X
100 (0.3┩%

or n敧慴楶攠捯nro氠(d楳瑩汬敤 w慴敲) we
r攠incub慴敤 w楴h h攠
瑩su攠 samp汥l 楮 6 we汬l p污l敳e 慴a 37

C, 5┠ CO
2

and


90┠ hum楤楴y.
Thr敥 d楦f敲敮 數posur攠p敲楯ds w敲攠us敤㨠20 m楮s, 1hr and 4 hrs for h攠
瑥獴 慲瑩捬攠and 5 m楮s, 20 mins and 1 hr for 瑨e r敦敲en捥.
䅦瑥
eposure
for 慮 unsp散楦
楥i p敲楯d
慮d r楮sing

w楴h phosph慴攠buff敲敤 s慬楮攠(B匩

瑨攠samp汥l
w敲e

subm敲g敤 楮 5 mL of assay m敤楡ifor 10 m楮s 慴aroom
瑥mp敲慴ar攮 Af瑥 慮o瑨敲 10 mins, e捥ss 汩lu楤 was r敭ov敤 慮d 瑨e
samp汥猠w敲e

in捵b慴敤 for 3 hours w楴h
300 때

-
[4,5
-
d業整hyl瑨楡穯l
-
2
-
y汝
-
2,5
-
d楰henyl
-
瑥瑲慺o汩lm brom楤攩

(䵔T) so汵瑩n. 䅦瑥 r楮sing w楴h
B匬S
h攠samp汥s w敲攠hen e瑲慣瑥

ov敲nigh琠and 瑨e 慢sorb慮捥 of 敡捨

數瑲慣瑡瑳
慴a 570 nm
w慳a
d整敲min敤
. Th攠 慢sorb慮捥 of 瑨攠 n敧慴楶e
捯n瑲o氠was def楮敤 as 100┠v楡i楬楴y, and 瑨e p敲捥n琠vi慢楬楴楥猠of h攠
samp汥猠l整敲min敤
propor瑩n慬ay
.


Th楳 m整hod v慲楥猠 from h攠 me瑨od 捵rr敮瑬y und敲go楮g v慬楤慴楯n
(䡡Hb敬氠整e慬a, 2009) du攠瑯 瑨攠mu汴楰汥lep
osur攠瑩mes, no pos
-
瑲敡men
楮捵b慴楯n s瑥, volum攠of 瑥琠ubs瑡n捥 us敤, 慢sorb慮捥 m敡sur敤 慴a570
nm ins瑥慤 of 550 nm 慮d h攠pr敤楣瑩in mod敬eus敤.




R
ESULTS


December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
21

of
27

Remarks
-

Results

The

test substance demonstrated 84
%
tissue viability

after 4 hrs
when
compared to the negative control (distilled water). In comparison, the
positive control (Triton X 100 (0.3%)) demonstrated

2
6
%

tissue

viability
after 1 hr

exposure
.



% viability after exposure

20 mins

1 hr

4hrs

Colonial SugaSulfonate

160 diluted
to 20% (0.8% notified chemical)

101

115

84

Triton X 100 (0.3%)

100

74

26


A

plot of
a semi
-
log scale of the
percentage tissue
viabilities versus
exposure

time was constructed. Interpolation of the plot, revealed the
time at which
tissue

viability would be 50% (ET
-
50) > 256 mins for the
test substance and approximately 34.8 mins for the positive control.


Based on ET
-
50 > 256 mins,
and the estimation method from Kay and
Calandra (1962)
t
he draize

score for the test substance was estimated at
0
,
with a “non
-
irritating” irritancy classification
.




C
ONCLUSION

Under the conditions of this test, the notified chemical is predicted to be
non
-
irritating to the eye at a concentration of 0.8%.




T
EST
F
ACILITY

Consumer Products Testing Co. (2004c
)


B.4.
Genotoxicity


bacteria



T
EST
S
UBSTANCE

Suga*Nate 160




M
ETHOD

Equivalent to: OECD TG 471 Bacterial Reverse Mutation Test.

EC Directive 2000/32/EC B.13/14 Mutagenicity


oev敲s攠䵵瑡瑩tn T敳e
using B慣瑥t楡i

m污瑥l楮捯rpor慴楯n pro捥dure

印散楥猯却牡in

S. typhimurium
: TA1535, TA1537, TA98, TA100

E. coli
: WP2uvrA

Metabolic Activation System

S9 fraction from Aroclor 1254
-
induced rat liver.

Concentration Range in

Main Test

a) With metabolic
activation:

50


RMMM 땧⽰污瑥

b) t楴iou琠m整慢o汩挠慣瑩v慴楯n:

㔰R


RMMM 땧⽰污瑥

噥s楣汥

䑍协

oem慲ks
J

䵥thod





o
ESULTS



Metabolic
Activation

Test Substance Concentration (µg/plate) Resulting in:

Cytotoxicity in
Preliminary Test

Cytotoxicity
in
Main Test

Precipitation

Genotoxic Effect

Absent





Test 1

-

≥ 1000

乯ne

乥k慴av攠

Present





Test 1

-

≥ 1000

乯ne

乥k慴av攠


oem慲ks
J

oesu汴l

乯 v楳楢汥l r敤u捴楯n 楮 th攠 b慣kground 污wn was obs敲v敤 fo汬lwing
瑲敡tmen琠w楴h 瑨攠瑥s琠tubs瑡n捥.


乯 subs瑡n瑩慬tin捲敡s攠楮 r敶敲瑡t琠捯汯ny numb敲s of 慮y of 瑨攠瑥獴敲
s瑲慩as w敲攠obs敲v敤 fo汬lwing 瑲敡tm敮琠wi瑨 th攠瑥獴 subs瑡t捥 慴a慮y
dos攠汥l敬e w楴i and w楴hou琠m整慢o汩挠慣瑩ta瑩tn.


Th攠 捯n捵rr敮t pos楴iv攠 con瑲o氠 捯mpounds E卯d極m A穩z攬
O
J
乩瑲of汵oren攬 Co NVN A捲id楮攬 䵥thyl 䵥th慮esulfon慴攠 E
J
匹)I O
J
December 2012

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FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
22

of
27

Aminoanthracene (+S9)) demonstrated the sensitivity of the assay and the
metabolising activity of the liver preparations.


Cytotoxicity was observed in the TA1537, TA100 and TA98 strains at

1000 and 5000 µg/plate without metabolic activation and the TA1535
strain at 5000 µg/plate without metabolic activation. Cytotoxicity was
also observed in the TA1537, TA1535 and TA100 strain at 1000 and
5000 µg/plate and in the TA98 strain at 5000 µg/plat
e in the presence of
metabolic activation.




C
ONCLUSION

The notified chemical was not mutagenic to bacteria under the conditions
of the test.





T
EST
F
ACILITY

Consumer Product Testing Co. (2009)

A
PPENDIX
C:

E
NVIRONMENTAL
F
ATE AND
E
COTOXICOLOGICAL
I
NVESTIGATIONS


C.1.

Environmental Fate


C.1.1.

Ready biodegradability

(1)



T
EST
S
UBSTANCE

Notified chemical




M
ETHOD

OECD TG 301 E Ready Biodegradability: Modified OECD Screening
Test.

Inoculum

Mixed activated sludge and secondary effluent

Exposure Period

28 days

Auxiliary Solvent

None

Analytical Monitoring

Dissolved
organic carbon

Remarks
-

Method





R
ESULTS



Test substance

Sodium benzoate

Day

% Degradation

Day

% Degradation

3

48



7

81



14

82

Data not reported

21

80



28

81




Remarks
-

Results

The inhibition control found no inhibitory effects from the

test substance.




C
ONCLUSION

The notified chemical is readily biodegradable.




T
EST
F
ACILITY

Silliker (2008)



C.1.2.

Bioaccumulation



Remarks

The notified chemical is not expected to bioaccumulate

in fish as it is
water soluble and readily biodegradable.


Extension
Application


C.1.3.

Ready biodegradability

(2)



T
EST
S
UBSTANCE

Notified chemical




M
ETHOD

OECD TG 301 D Ready Biodegradability: Closed Bottle Test.

Inoculum

Activated sludge

December 2012

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FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
23

of
27

Exposure
Period

28 days

Auxiliary Solvent

None

Analytical Monitoring

Dissolved organic carbon

Remarks
-

Method

The test chamber temperature was not recorded on Days 2, 3, 10 and 17.
The test temperature exceeded the protocol range on Day 19.




R
ESULTS



Test

substance

Aniline

Day

% Degradation

Day

% Degradation

7

59.4


7

27.7

14

75.2


14 63.6

21

96.6

21

70.1

28

83.4

28

64.7


Remarks
-

Results

The inhibition control found no inhibitory effects from
the test substance.


The control substance
aniline

was degraded
64.7
% within 28 days. The
threshold of readily biodegradability of ≥ 60% for the control substance
was m整ewi瑨楮


days. A汬lv慬楤楴y 捲楴敲楡ifor 瑨攠瑥s琠w敲攠s慴楳f楥i.




C
ONCLUSION

The notified chemical is readily biodegradable.




T
EST
F
ACILITY

S
tillmeadow (2011
)


C.2.



Ecotoxicological Investigations


C.2.1.

Acute toxicity to fish



T
EST
S
UBSTANCE

Notified chemical (40% aqueous solution).




M
ETHOD

In house method based on US EPA protocol

Species

Eastern rainbowfish (
Melanotaenia splendid
a)

Exposure Period

96 hours

Auxiliary Solvent

None

Water Hardness

Not reported

Analytical Monitoring

None

Remarks


䵥thod

fmb慬慮捥 w慳a us敤 慳 敮dpo楮琬t r慴a敲 瑨慮 mor瑡汩ly. The
捯n捥n瑲慴楯ns 瑡tu污瑥t b敬ew 慲攠of th攠瑥獴 subs瑡n捥 E4M┠獯汵瑩tn).




o
ESULTS



Concentration mg/L

Number of Fish

Imbalance %

Nominal

Actual


1 h

24 h

48 h

72 h

96 h

0


Not reported





0

10


Not reported





0

20


Not reported





25

40


Not reported





80

80


Not reported





100

120


Not reported





100


EC50

10.9 mg/L at

96 hrs.

NOEC

4 mg/L at 96 hrs.

Remarks


oesul瑳

Th攠r敳e汴l hav攠b敥n 捯rr散瑥t 瑯 r敦汥捴lth攠捯n捥n瑲慴楯n E4M┩Bof 瑨e
no瑩晩td 捨em楣慬i楮 th攠瑥s琠tubs瑡t捥.




C
ONCLUSION

The notified chemical is harmful to fish.




T
EST
F
ACILITY

Ecotox

Services Australia (2008a)

December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
24

of
27



C.2.2.

Acute toxicity to aquatic invertebrates



T
EST
S
UBSTANCE

Notified chemical (40% aqueous solution).




M
ETHOD

In house method based on US EPA protocol

Species

Ceriodaphnia dubia

Exposure Period

48 hrs

Auxiliary Solvent

None

Water Hardness

Not reported

Analytical Monitoring

None

Remarks
-

Method

Mortality was used as endpoint. The concentrations tabulated below are
of the test substance (40% solution).


R
ESULTS



Concentration mg/L

Number of C dubia

Percentage
Immobilised

Nominal

Actual


24 h

48 h

0


Not reported


0

0.6


Not reported


0

1.25


Not reported


0

2.5


Not reported


0

5


Not reported


0

10


Not reported


0

20


Not reported


80

40


Not reported


100


LC50

6.5 mg/L at 48 hrs

NOEC

4.0 mg/L at 48 hrs

Remarks


oesul瑳

Th攠r敳e汴l hav攠b敥n 捯rr散瑥t 瑯 r敦汥捴lth攠捯n捥n瑲慴楯n E4M┩Bof 瑨e
no瑩晩td 捨em楣慬i楮 th攠瑥s琠tubs瑡t捥.




C
ONCLUSION

The notified chemical is toxic to daphnids.




T
EST
F
ACILITY

Ecotox Services
Australia (2008b)



C.2.3.

Algal growth inhibition test



T
EST
S
UBSTANCE

Notified chemical (40% aqueous solution).




M
ETHOD

In house method based on US EPA protocol

Species

Selenastrum capricornutum

Exposure Period

72 hrs

Concentration Range

Nominal: 0,
14, 29, 57.5, 115 and 230 mg/L test substance (40% solution)

Auxiliary Solvent

None

Water Hardness

Not reported

Analytical Monitoring

None

Remarks
-

Method





R
ESULTS



Biomass

Growth

EC50>

NOEC

IC50>

NOEC

mg/L at 72 h


mg/L

mg/L at72 h


mg/L



21.2

11.6


Remarks
-

Results

The results have been corrected to reflect the concentration (40%) of the
notified chemical in the test substance.

December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
25

of
27




C
ONCLUSION

The notified chemical is harmful to green algae.




T
EST
F
ACILITY

Ecotox Services Australia

(2008c)


December 2012

NICNAS


FULL PUBLIC REPORT: EX/178 (STD/1331)

Page
26

of
27

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