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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Annex V (Micronucleus test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: Mouse(albino)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Arachis oil B.P.
No. of animals per sex per dose:
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: 5000 mg/kg
Additional information on results:
Observations:
There was no evidence of a biologically significant increase
in the incidence of micronucleated polychromatic or
normochromatic erythrocytes in animals dosed with the test
material when compared to the vehicle control groups. No
significant changes in the NCE/PCE ratio was observed after
dosing with the test material.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative