Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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

Constituent 1
Chemical structure
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
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
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.