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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP-Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chloro-α,α,α-trifluoro-o-toluidine
EC Number:
207-151-3
EC Name:
4-chloro-α,α,α-trifluoro-o-toluidine
Cas Number:
445-03-4
Molecular formula:
C7H5ClF3N
IUPAC Name:
4-chloro-α,α,α-trifluoro-o-toluidine

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Sesame Oil
Duration of treatment / exposure:
24, 48, 72 h
Doses / concentrations
Remarks:
Doses / Concentrations:
1250 mg/kg
Basis:
nominal conc.
Testsubstance
No. of animals per sex per dose:
5
Control animals:
yes
Positive control(s):
Endoxan®

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
No death, but reduced spontaneous activity, uncoordinated gait, ataxic gait. Reversible within 24 h.
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative

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