Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.12 (Mikrokerntest); OECD 474
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: mus, NMRI

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Wasser/Cremophor 0,5 %

"ENGLISH"

water/cremophor 0,5 %
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2500 mg/kg; No. of animals: 5; Sacrifice time: 16 hours
Male: 2500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2500 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 16 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: Klinische Symptome, Letalität, cytotoxische Effekte (PCE/NCE) "ENGLISH" clinical symptoms, letality, cytotoxic effects (PCE/NCE).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative