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: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
yes
Remarks:
: lack of details on test substance
GLP compliance:
no
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
- Physical state: Paste
- Analytical purity: 30% a.i.
- Lot/batch No.: No data
- Storage condition of test material: No data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
According to guideline.

Administration / exposure

Route of administration:
oral: feed
Vehicle:
water
Duration of treatment / exposure:
90 days
Frequency of treatment:
Daily
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
1.13%
Basis:
nominal in diet
No. of animals per sex per dose:
6
Control animals:
yes, plain diet
Positive control(s):
Yes.

Examinations

Tissues and cell types examined:
Bone marrow cells
Details of tissue and slide preparation:
SAMPLING TIMES:
after 90 days
Evaluation criteria:
According to guideline.
Statistics:
No.

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative