Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: 84/449/EWG, B.12 (Mikrokerntest)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: mus, NMRI

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Polyethylenglykol 400
No. of animals per sex per dose:
Male: 200 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 670 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 200 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 670 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Additional information on results:
Doses producing toxicity:
Unspecific toxic symptoms at 2000 mg/kg, no deaths; very
slight cytotoxic effec (PCE/NCE) at 2000 mg/kg and 48 h.



No increase of the micronucleus rate in the animals treated
with the substance.

Unspecific toxic symptoms at 2000 mg/kg. No deaths; very
slight cytotoxic effext (PCE/NCE) at 2000 mg/kg and 48 h.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative