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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)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973
Reference Type:
publication
Title:
Testing Mutagenic Properties with the Dominant Lethal Test on the Male Mouse.
Author:
Lorke D. and Machemer L.
Year:
1975
Bibliographic source:
Environmental Quality and Safety, Suppl. Vol. 4, 239-246

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
GLP compliance:
not specified
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
Single dosage.
Frequency of treatment:
Once.
Doses / concentrations
Remarks:
Doses / Concentrations:
5000 mg/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
20 males and 480 females.
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
Number of fertile matings, implantation, resorption, live foetuses, and corpora lutea.
Statistics:
The χ2-test, the t-test or the distribution-free rank sum test (Wilcoxon) were used to assess the results.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative