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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment Adopted according to OECD SIDS or other official EU regulation procedures (public available peer reviewed source).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Reference Type:
secondary source
Title:
SIDS Category of Alkyl sulfates, Alkane sulfonates and Alpha-olefin sulfonates
Author:
OECD
Year:
2007
Bibliographic source:
UNEP Publications

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
Deviations:
yes
Remarks:
Only limited data on test material and methodology available
GLP compliance:
no
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): No data
- Physical state: No data
- Analytical purity: No data
- Lot/batch No.: No data
- Storage condition of test material: No data

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle used: water
Duration of treatment / exposure:
single dose
Frequency of treatment:
not applicable, single dose
Post exposure period:
Not applicable.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 120, 380 or 1200 mg/kg bw
Basis:

No. of animals per sex per dose:
15 males per dose in the test group and the positive control group
30 males negative controls
- Fertility testing: A total of 375 males were caged with 750 virgin females
- Experimental mating: 2 virgin females were cohoused with the 225 males with proven fertility (which were separated into different treatment groups).
Control animals:
yes
Positive control(s):
yes, orally 200 mg ethylmethanesulphonate/kg bw

Examinations

Tissues and cell types examined:
Uteri of sacrificed mice were examined for live implantations, early and late deaths. Males were not further examined.
Statistics:
week by week hierarchical analysis of variance

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative

Any other information on results incl. tables

No adverse effects on pregnancy frequency, number of implantations or 

frequency of early deaths

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative