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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
: lack of details on test substance
GLP compliance:
yes
Type of assay:
micronucleus 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: No data
- Analytical purity: 55% a.i.
- Lot/batch No.: No data
- Storage condition of test material: No data

Test animals

Species:
mouse
Strain:
other: CFW 1
Sex:
male/female
Details on test animals and environmental conditions:
According to guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Duration of treatment / exposure:
24 h (400, 2000, 4000 mg/kg bw)
48, 72 h (4000 mg/kg bw)
Frequency of treatment:
Single
Post exposure period:
n.a.
Doses / concentrations
Remarks:
Doses / Concentrations:
400, 2000, 4000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
7
Control animals:
yes, concurrent vehicle
Positive control(s):
Yes.

Examinations

Tissues and cell types examined:
Bone marrow
Details of tissue and slide preparation:
SAMPLING TIMES:
24, 48 and 72 hours after application

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 applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative