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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD No. 474 EC 2000/32, B.12 EPA/OPPTS 870.5395
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
457-830-5
EC Name:
-
Cas Number:
2557-13-3
Molecular formula:
Hill formula: C9 H7 F3 O2
IUPAC Name:
Methyl, 3-Trifluoromethylbenzoate

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
corn oil
No. of animals per sex per dose:
Male: 125 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours

Examinations

Tissues and cell types examined:
bone marrow of the two femora

Results and discussion

Test results
Sex:
male
Genotoxicity:
positive
Additional information on results:
Dose producing toxicity in the pre-test for dose selection: 750 mg/Kg body weight

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The single oral administration of Methyl 3-(trifluoromethyl) benzoate did not lead to any increase in the number of polychromatic
erythrocytes containing either small or large micronuclei.The rate of micronuclei was always close to the same range as that of the concurrent negative control in all dose groups and at all sacrifice intervals and within the range of the historical control data.
No relevant inhibition of erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was detected.
Thus, under the experimental conditions chosen here, the test substance does not have any chromosome-damaging (clastogenic) effect,
and there were no indications of any impairment of chromosome distribution in the course of mitosis (aneugenic activity) in bone marrow cells in vivo.