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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vivo

Description of key information
RZ 97 and its metabolites did not induce gene mutations in the strains of S. typhimurium used. RZ 97does not induce any statistically significant increase in the frequency of micronucleated cells in the bone marrow.
Link to relevant study records
Reference
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)
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
micronucleus assay
Species:
rat
Strain:
other: Crl:CD(SD)BR Sprague Dawley rat
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
- Vehicle(s)/solvent(s) used: Corn oil
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Sex:
male/female
Toxicity:
yes
Remarks:
(Doses producing toxicity: The ratio of polychromatic to normochromatic erythrocytes in both male and female animals remained unaffected by the treatment with RZ 97, indicating that the test substance is not toxic to bone marrow.)
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Conclusions:
Interpretation of results (migrated information): negative
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vivo:

Justification for selection of genetic toxicity endpoint
Test conducted according to internationally accepted testing guidelines.

Justification for classification or non-classification

According to the Regulation EC n. 1272/2008 RZ 97 is considered as non mutagenic