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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Test animals

Species:
other: Mouse (CD-1)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Arachis oil
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 7; Sacrifice time: 48 hours
Male: 2000 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 7; Sacrifice time: 48 hours
Male: 1000 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 500 mg/kg; No. of animals: 7; Sacrifice time: 24 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: There were no deaths, and no clinical signs of toxicity were observed. No statistically significant decreases in the PCE/NCE ration were observed in the 24 and 48-hour test groups when compared to controls.
Additional information on results:
Observations:
There was no evidence of a significant increase in the
incidence of micronucleated polychromatic erythrocytes in
test group animals compared to vehicle controls. The
positive control material produced a marked increase in the
frequency of micronucleated polychromatic erythrocytes.
Negative control values were within historical ranges.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative