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Toxicological information

Genetic toxicity: in vivo

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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
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: mus, Hsd Win: NMRI

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Tylose 0,5 % in aqua dest.
No. of animals per sex per dose:
Male: 2150 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2150 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 2150 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2150 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: 2150 mg/kg
Additional information on results:
Observations:
Je 1 von 14 Tieren der Testgruppe zeigte Writhing Syndrom
und 1 Tier starb mehr als 24 nach der Applikation. Die Dosis
war die nach Guideline maximal zu applizierende Dosis.

Keine Cytotoxizität (PCE/NCE).

"ENGLISH"

Each one of 14 animals of the test group showed the writhing
syndrome and 1 animal died more than 24 h p.a.. The dosis
was the maximal dosis according to the guideline.

No cytotoxicity (PCE/NCE)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative