Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trade name
- Ethoxylation degree: No data
- Physical state: Colourless-yellowish liquid
- Analytical purity: 27-29% a.i.
- Lot/batch No.: 69/94
- Storage condition of test material: At RT in the dark

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Distilled water
Duration of treatment / exposure:
n.a.
Frequency of treatment:
Once
Post exposure period:
test group: 10, 24 and 48 h
positive control: 26 h
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 2000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophosphamide (50 mg/kg bw)

Examinations

Tissues and cell types examined:
Femoral bone marrow cells
Details of tissue and slide preparation:
SAMPLING TIMES
test groups: 10, 24 and 48 h after treatment
positive control group: 26 h after treatment
Evaluation criteria:
According to Guideline.
Statistics:
Yes

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative