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EC number: 500-465-4
CAS number: 160901-28-0
1 - 2.5 moles ethoxylated
skin irritation (OECD 439): irritatingeye irritation (OECD 405): highly irritating / corrosiveSCLs according to GHS:>=5% - <10% Eye Irrit. Cat.2< 5% No Classification
1: Summary of results
Treatment period (min)
Mean inter tissue viability difference (%)
* Only two test item treated tissues instead of three were
evaluated due to loss of one tissue during washing.
The test meets acceptance criteria if:
Mean OD of the three negative control tissues is above≥ 1 and ≤2.5
Mean relative tissue viability of the three positive controls is
at or below 20%,
The maximum inter tissue viability difference (determined as SD)
between tissues treated identically is at or below 18%.
The mean OD value of the two negative control tissues of the 3 and 60
minute treatment period is above 0.8. The mean relative tissue viability
of the two positive controls of the 3 minute treatment period is below
30%. The maximum inter tissue viability difference between tissues
treated identically is below 30%.
One study investigating the skin irritating properties of AES (C9-11)Na
(CAS 160901-28-0, analytical purity 30%) is available while no data for
the neat substance is available for skin and eye irritation. Therefore
the endpoint skin irritation is covered by read-across from structurally
related AES, i.e. AES (C8-10)Na. With regard to the endpoint eye
irritation AES (C9-11)Na (CAS 160901-28-0) is classified as worst case
scenario according to the classification criteria of Regulation (EC) No.
1272/2008 as Eye Dam.1, H318. However, to assess specific concentration
limits (SCL) for eye irritation a read across to structurally related
AES, i.e. AES (C12-14, 1-2.5 EO)Na (CAS 68891-38-3) and AES (C10-16,
1-2.5 EO)Na (CAS68585-34-2) was performed. The AES reported within the
AES category show similar structural, physico-chemical, environmental
and toxicological properties. The approach of grouping different AES for
the evaluation of their effects on human health and the environment was
also made by the Danish EPA (2001) and HERA (2003), supporting the
read-across approach between structurally related AES. Within the HERA
report (2003) it was concluded that “The skin irritating properties of
AES normally decrease with increasing level of ethoxylation.” Therefore
read-across was performed from AES with an ethoxylation grade of 1 - 2.5
reflecting the ethoxylation grade of AES (C9-11)Na (CAS 160901-28-0).
There are one study with AES (C9-11)Na (CAS 160901-28-0, analytical
purity 30%) and two studies for the read-across substanceAES (C8-10)Na
(CAS not yet assigned) addressing skin irritation available.
One in vitro study was performed according to OECD Guideline 431 to
assess the skin corrosive potential of AES (C8-10, 2 EO)Na. 25 mg of the
test substance was applied atop an EpiDerm ™ tissue, comprising of a
reconstructed epidermis with a functional stratum corneum, for 3 and 60
minutes (Z&S, 2012c). The viability of the treated tissue, as assessed
via the MTT assay, was 84% of control after 3 min exposure and 48% of
control after 60 min exposure period. Thus, AES (C8-10, 2 EO)Na was not
The second study with AES (C8-10, 2 EO)Na was performed according to
OECD Guideline 439. 25 mg of the test substance was applied atop an
EpiDerm ™ tissue, comprising of a reconstructed epidermis with a
functional stratum corneum, for 60 minutes (Z&S, 2012d). The viability
of the treated tissue, as assessed via the MTT assay, was 7% of control
after 60 min exposure. Thus, AES (C8-10, 2 EO)Na (CAS Not yet assigned)
The in vivo study with AES (C9-11)Na (CAS 160901-28-0, analytical purity
30%) was performed similar to OECD guideline 404. Six New Zealand White
rabbits were treated with 0.5 mL for 24 h under occlusive conditions
(Huntsman 1977b). As the 48 hours reading was missing this was
extrapolated from the 24 and 72 hour reading time point. The mean
erythema and the mean edema score (24, 48 and 72 h) were 1.6 and 1.1,
respectively. It was stated that only the intact skin values were used
for grading the skin lesions. In addition no information on
reversibility of the effects is available as the observation period was
only 72 h. Therefore this study is not suitable for classification
Data on eye irritation:
As worst case scenario AES (C9-11, 1 -2.5 EO)Na (CAS 160901-28-0) is
classified according to the classification criteria of Regulation (EC)
No. 1272/2008 as Eye Dam.1, H318.
However, as corrosion and irritation depends on the concentration of the
substance in a solvent, further studies with lower concentrations of the
test substance were also considered to assess whether specific
concentration limits can be set. For this purpose, two studies with AES
(C12-14, 4 EO)Na (CAS 68891-38-3) and two studies with AES (C10-16, 2
EO)Na (CAS68585-34-2) with an concentration range of 1 to 10% were
One study was performed with 0.1 mL AES (C12-14, 4 EO)Na (CAS
68891-38-3, analytical purity 10%) similar to OECD guideline 405
(Stepan, 1980a) on three New Zealand White rabbits with an observation
period of 7 days. The mean (24, 48 and 72 h reading) cornea, iris,
conjunctivae and chemosis scores over all animals were 1.6, 0.6, 2 and
1.6 representing an eye irritating effect of the test substance at a
concentration of 10% . The effects were not fully reversed within the 7
days observation period. Therefore the test substance showed eye
The second study was performed with 0.1 mL AES (C12-14, 4 EO)Na (CAS
68891-38-3) similar to OECD guideline 405 (Stepan, 1980b) on three New
Zealand White rabbits with an observation period of 7 days, however at
an concentration of 5%. The mean (24, 48 and 72 h reading) cornea, iris,
conjunctivae and chemosis scores over all animals were 0.4, 0, 1 and
0.3. All effects reversed within the 7 days observation period. Thus,
the test substance was not irritating to the eye at a concentration of
In a further supporting study with AES (C12-14, 2 EO)Na (CAS
68891-38-3, analytical purity 27%) according to OECD guideline 405, 0.1
mL of the test substance was applied to the rabbits eye at a
concentration of 20% resulting in an actual concentration of 5.4% (Z&S,
1997). The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and
chemosis scores over all animals were 0, 0, 1.2 and 0. The conjunctival
redness reversed within the 7 days observation period. Thus the test
substance was not irritating to eyes at a concentration of 5.4 %.
The supporting study with AES C10-16Na (CAS 68585-34-2, no data on grade
of ethoxylation, analytical purity 58%) was performed similar to OECD
guideline 405 (Unilever, 1980).The mean (24, 48 and 72 h reading)
cornea, iris, conjunctivae and chemosis scores over all animals were
0.7, 1, 3 and 3.3. All findings were fully reversible within the
observation period. Thus, the test substance showed eye irritating
properties at a concentration of 5%.
Based on the above mentioned results with different concentrations of
structurally related alkyl ether sulfates a cut of value for
classification as severe irritating to eyes is set at a concentration of
10% and for classification as irritating at a concentration of 5% for
the AES of the category.
Danish EPA - Environmental and Health Assessment of Substances in
Household Detergents and Cosmetic Detergent Products (2001).
Environmental Project No. 615, pp. 24-28
HERA (2003). Human & Environmental Risk Assessment on ingredients of
European household cleaning products Alcohol Ethoxysulphates, Human
Health Risk Assessment Draft, 2003. http: //www. heraproject. com.
According to the classification criteria of Regulation (EC) No.
1272/2008 the test substance needs to be classified with Skin Irrit. 2,
H315 and Eye Dam.1, H318.
It could be shown with experimental data on eye irritation that
below 10% active substance only the classification Eye Irrit. Cat.2
remains and below 5% active substance no classification at all is
necessary. Hence, the Generic Concentration Limits (GCLs) can be
substituted by the mentioned specific ones (SCLs).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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