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EC number: 500-464-9
CAS number: 160901-27-9
1 - 2.5 moles ethoxylated
The assessment is based on the data currently available. New studies,
based on the category review and the final decisions issued for some of
the category substances, which are also relevant for this assessment,
are currently being conducted. The hazard assessment with respect to
genetic toxicity will be updated once all ongoing studies have been
No data on genetic toxicity are available for AES (C9-11, 1-2.5
EO) NH4 (CAS 160901-27-9). Therefore this endpoint is covered by read
across from structurally related AES, i.e. AES (C8-10, 1-2.5 EO) Na and
AES (C12-14; 1-2.5 EO) Na (CAS 68891-38-3). 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. For further details on
the suitability of the read-across please refer to the AES Category
In general a lack of mutagenic activity for the AES category is
predictable based on structural and mechanistic considerations. Mutagens
are chemicals that either 1) contain highly reactive electrophilic
centers capable of interacting with nucleophilic sites on DNA (direct
acting agents) or 2) can be metabolized to highly reactive
electrophiles. The chemical structures represented by this chemical
class do not contain electrophilic functional groups or functional
groups capable of being metabolized to electrophiles. AES are readily
absorbed in the gastrointestinal tract in human and rat and excreted
principally via the urine or faeces depending on the length of the
ethoxylate chain but independently of the route of administration. Once
absorbed, AES are extensively metabolized by beta- or omega oxidation.
The EO-chain seems to be resistant to metabolism. Thus, AES with fully
saturated carbon chains are not metabolized to reactive electrophiles.
There are two studies for the read-across substance AES (C8-10,
1-2.5 EO) Na and one study for the read-across substance AES (C12-14;
1-2.5 EO) Na (CAS 68891-38-3) addressing genetic toxicity available.
Mutagenicity of AES (C8-10, 2 EO) Na in bacteria was
assessed in a study performed according to OECD Guideline 471 with
Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 102 and TA
100 (Wallner, 2012). The tester strains were treated using the plate
incorporation and the pre incubation method both with and without the
addition of a rat liver S9-mix. The concentrations for both testing
methods was 3.16, 10, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate.
Results achieved with vehicle (distilled water) and positive controls
were valid. Cytotoxicity was seen in presence and absence of metabolic
activation while no genotoxicity was observed under both circumstances.
The mutagenicity of AES (C8-10, 2 EO) Na in a mammalian
cell line was investigated according to OECD guideline 476 using the
mouse lymphoma L5178Y cells with and without metabolic activation
(Trenz, 2012). The test concentrations were 0.01, 0.02, 0.05, 0.10,
0.20, 0.24, 0.28, 0.32 mM without metabolic activation as well as 0.01,
0.05, 0.24, 0.28, 0.32, 0.36, 0.40, 0.44, 0.48 mM with metabolic
activation in the first experiment (4 h incubation). In the second
experiment the cells were incubated with concentrations of 0.15, 0.35,
0.39, 0.43, 0.45, 0.47, 0.49, 0.53 mM in the presence of metabolic
activation for 4 h and at concentrations of 0.0005, 0.001, 0.005, 0.01,
0.05, 0.10, 0.15, 0.20, 0.25 mM in the absence of metabolic activation
for 24 h. Results achieved with the vehicle (RPMI medium) and positive
controls were valid. Cytotoxicity was seen in presence and absence of
metabolic activation. No genotoxicity was observed, except for the
highest dose level in experiment I with metabolic activation where a
significantly increased number of mutants and a dose dependency were
seen at 0.48 mM. In addition the Global Evaluation Factor of 126 was
exceeded by the induced mutant frequency. This effect was observed in
the highly cytotoxic range only (relative total growth below 10%) and
was not verified in the verification experiment (experiment II with
metabolic activation). Therefore this effect was considered to be of no
The in vivo clastogenic potential of AES (C12-14) Na (CAS
68891-38-3, analytical purity 27-29%, no data on grade of ethoxylation)
was assessed in a mammalian bone marrow chromosomal aberration test with
CD-1 mouse according to OECD Guideline 475 (Ciliutti, 1995). The test
substance was administered via gavage at doses of 1000 and 2000 mg/kg bw
to five animals per sex per dose. Distilled water was used as vehicle.
The post exposure period were 10, 24 and 48 h for the test group
including the vehicle control and 26 h for the positive control group.
Results achieved with the negative (distilled water) and positive
controls were valid. No signs of toxicity and no increased number of
chromosome aberration were seen at 1000 and 2000 mg/kg bw. Thus the test
substance did not show clastogenicity at 1000 and 2000 mg/kg bw based on
the test material and 270 to 290 and 540 to 580 mg/kg bw based on the
In conclusion, AES and their metabolites lack the structural
moieties which confer mutagenic properties. This is reflected by the
lack of reliable positive genotoxicity studies within the AES category.
This is supported by the conclusions of the HERA report for AES were it
is stated that: “In all available in vitro and in vivo genotoxicity
assays, there is no indication of genetic toxicity of AES.”
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.
Justification for selection of genetic toxicity endpoint
No study selected as outcome is negative.
Short description of key information:
In vitro bacterial reverse mutation assay (Ames test / OECD
guideline 471): negative
In vitro mammalian cell gene muatation assay (MLA / OECD guideline 476):
In vivo mammalian chromosome aberration assay (CA / OECD guideline 475):
Endpoint Conclusion: No adverse effect observed (negative)
According to the classification criteria of Directive 67/548/EEC
and Regulation (EC) No 1272/2008 the substance does not need to be
classified for genotoxicity.
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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