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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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

Constituent 1
Reference substance name:
68955-20-4 (purity 55%)
IUPAC Name:
68955-20-4 (purity 55%)
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 or test system 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