sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Chromosome Aberration and Sister Chromatid Exchange Tests in Chinese Hamster Ovary Cells In Vitro. V: Results with 46 Chemicals

Author:

Loveday et al.

Year:

1990

Bibliographic source:

Environmental and Molecular Mutagenesis 16:272-303 (1990)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

yes

Remarks:

Not all results displayed.

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Sodium etasulfate

EC Number:

204-812-8

EC Name:

Sodium etasulfate

Cas Number:

126-92-1

Molecular formula:

C8H18O4S.Na

IUPAC Name:

sodium 2-ethylhexyl sulfate

Method

Target gene:

n.a.

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

501, 1500, 5010 µg/mL

Vehicle / solvent:

water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: mitomycin, 5 µg/mL (-S9); cyclophosphamide, 50µg/mL (+S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

Evaluation criteria:

According to guideline.

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

The test item was not considered to be clastogenic.

Executive summary:

No enhanced aberration rate in the presence or absence of metabolic activation was observed in this chromosomal aberration assay. Therefore, the test substance was not considered to be clastogenic.