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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4'-benzyloxy-2-bromopropiophenone
EC Number:
252-351-6
EC Name:
4'-benzyloxy-2-bromopropiophenone
Cas Number:
35081-45-9
Molecular formula:
C16H15BrO2
IUPAC Name:
1-[4-(benzyloxy)phenyl]-2-bromopropan-1-one
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
30% DMSO / 70% PEG 400 used as vehicle control.
Frequency of treatment:
Single administration.
Post exposure period:
24 h and 48 h after a single administration of the test item the bone marrow cells were collected for micronuclei analysis.
Doses / concentrationsopen allclose all
Dose / conc.:
500 mg/kg bw/day
Remarks:
24 h preparation interval
Dose / conc.:
1 000 mg/kg bw/day
Remarks:
24 h preparation interval
Dose / conc.:
2 000 mg/kg bw/day
Remarks:
24 h preparation interval
Dose / conc.:
2 000 mg/kg bw/day
Remarks:
48 h preparation interval:
Positive control(s):
40 mg/kg b.w. cyclophosphamide administered orally was used as positive control which showed a substantial increase of induced micronucleus frequency.

Examinations

Tissues and cell types examined:
Polychromatic erythrocytes (PCE) in the bone marrow of the mouse.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse.
Therefore, TSE-1 is considered to be non-mutagenic in this micronucleus assay.