Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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 finalised.

Bacterial reverse mutation assay (Ames / OECD 471): negative
In vitro mammalian cell gene mutation assay (MLA / OECD 476): negative

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

No E.coli strains tested.

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Target gene:

His operon

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 11, 56, 280, 1400, 7000 µg/plate

Vehicle / solvent:

water

Negative solvent / vehicle controls:

yes

Remarks:

destilled water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 9-aminoacridine, sodium azide, 2-nitrofluorene, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

Evaluation criteria:

According to Guideline.

Statistics:

yes

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Conclusions:

Interpretation of results: negative

Reference 2

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

mammalian cell gene mutation assay

Target gene:

TK operon

Species / strain / cell type:

mouse lymphoma L5178Y cells

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

-S9: 2.44, 4.88, 9.76, 19.5, 39.1, 58.6 µg/mL
+S9: 2.44, 4.88, 9.76, 19.5, 39.1, 78.1, 117 µg/mL

Vehicle / solvent:

n.a.

Untreated negative controls:

yes

Remarks:

untreated cells

Negative solvent / vehicle controls:

no

Remarks:

no vehicle used

Positive controls:

yes

Positive control substance:

other: ethylmethanesulphonate, 7,12-dimethylbenzanthracene

Evaluation criteria:

According to Guideline.

Statistics:

yes

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not examined

Untreated negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

Interpretation of results: negative

Reference 3

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

No E.coli strains tested.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Target gene:

His operon

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 10, 100, 1000, 10000, 100000 µg/plate

Vehicle / solvent:

destilled water

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

destilled water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 9-aminoacridine, sodium azide, 2-nitrofluorene, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

Evaluation criteria:

According to Guideline.

Statistics:

yes

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

Interpretation of results: negative

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Mammalian Bone Marrow Chromosome Aberration Test (CA / OECD 475): negative

Link to relevant study records

Reference

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

chromosome aberration assay

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

According to Guideline.

Route of administration:

oral: gavage

Vehicle:

Distilled water

Duration of treatment / exposure:

n.a.

Frequency of treatment:

Once

Post exposure period:

test group: 10, 24 and 48 h
positive control: 26 h

Remarks:

Doses / Concentrations:
0, 1000, 2000 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Positive control(s):

Cyclophosphamide (50 mg/kg bw)

Tissues and cell types examined:

Femoral bone marrow cells

Details of tissue and slide preparation:

SAMPLING TIMES
test groups: 10, 24 and 48 h after treatment
positive control group: 26 h after treatment

Evaluation criteria:

According to Guideline.

Statistics:

Yes

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Conclusions:

negative

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

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 finalised.

The genetic toxicity of alcohol ethoxysulfates (AES) was evaluated in several in vitro and in vivo genotoxicity tests. 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 details please refer to the category justification attached in IUCLID section 13.

Studies which were undertaken in vitro using a number of test systems have resulted in negative findings. The Ames tests conducted with AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) u

sing strains of S. typhimurium showed negative results. Testing for mammalian genotoxicity with AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) revealed a negative outcome as well. The result of in vivo testing revealed that the substance AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) has no clastogenic potential. According to the Regulation EC No. 1907/2006 (REACH) VIII 8.4.2, column 2, an in vitro cytogenicity study in mammalian cells does not need to be conducted if adequate data from an in vivo cytogenicity test are available. 

Based on the outcome of these tests also AES (C12-13, 1-2.5 EO) Na (CAS 161074-79-9) can be considered as non-genotoxic.

 

References:

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 classification or non-classification

The available data on genetic toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.