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
Guideline:
other: OECD 474
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: mus, Han: NMRI (SPF)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
0,9 % NaCl-Lösung
No. of animals per sex per dose:
Male: 500 mg/kg; No. of animals: 13; Sacrifice time: 24 hours
Male: 1000 mg/kg; No. of animals: 13; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 13; Sacrifice time: 24 hours
Female: 500 mg/kg; No. of animals: 13; Sacrifice times: 24 hours
Female: 1000 mg/kg; No. of animals: 13; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 13; Sacrifice times: 24 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: 1000 und 2000 mg/kg
Additional information on results:
Observations:
Nach 2000 mg/kg starben nahezu alle Tiere, daher nur 2
Dosierungen ausgewertet. Nach 1000 mg/kg geringgradige
Anzeichen von Toxizität.


"ENGLISH"

Nearly all animals died after a dose of 2000 mg/kg.
Therefore only 2 doses could be used for evaluation. Slight
signs of toxicity were seen after 1000 mg/kg.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative