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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 / bone marrow chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-06-07 to 1991-04-22
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-nitro-m-xylene
EC Number:
201-947-4
EC Name:
4-nitro-m-xylene
Cas Number:
89-87-2
Molecular formula:
C8H9NO2
IUPAC Name:
2,4-dimethyl-1-nitrobenzene

Test animals

Species:
hamster, Chinese
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
6h, 24h, 48h
Frequency of treatment:
one single application
Doses / concentrations
Remarks:
Doses / Concentrations:
6h: 4000mg/kg bw; 24h: 400, 1330, and 4000 mg/kg bw; 48h 4000 mg/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
5 males and 5 females per group, except for the highest dose: 4 males and 4 females because of mortalities
Control animals:
yes, concurrent vehicle
other: positive control group administered with cyclophosphamide

Examinations

Tissues and cell types examined:
Bone marrow cells

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
In conclusion it can be stated that during the mutagenicity test described and under the experimental conditions reported, the test article did not induce chromosome mutations as determined by the chromosome aberration test with bone marrow cells of the Chinsese hamster. Therefore, Nitro-m-xylol is considered to be non-mutagenic in this chromosome aberration assay in vivo.