Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP complicance, not OECD guideline

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.11 (Säuger-Knochenmark zytogenetischer in vivo-Test, Chromosomenanalyse)
GLP compliance:
yes
Type of assay:
other: in vivo mammalian bone marrow cytogenetic test

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Aqua dest.
No. of animals per sex per dose:
Male: 100 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 200 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 400 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 150 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 300 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 600 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
400 mg/kg b.w.(males), 600 mg/kg b.w. (females) At these dosis toxic symptomes such as reduction of spontaneous activity, eyelid closure (only in females) and apathy occured.
Additional information on results:
Observations:
No statistically significant increase in the frequency of aberrant cells occurred after treatment with the test item as compared to the vehicle control.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative