Registration Dossier
Registration Dossier
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EC number: 204-646-6 | CAS number: 123-72-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Micronucleated erythrocyte frequency in peripheral blood of B6C3F(1) mice from short-term, prechronic, and chronic studies of the NTP carcinogenesis bioassay program.
- Author:
- Witt, K.L., Knapton, A., Wehr, C.M., Hook, G.J., Mirsalis J., Shelby M.D., MacGregor J.T.
- Year:
- 2 000
- Bibliographic source:
- Environ Mol Mutagen. 2000;36(3):163-94.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Data presented in this study sre for studies not previously published.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Butyraldehyde
- EC Number:
- 204-646-6
- EC Name:
- Butyraldehyde
- Cas Number:
- 123-72-8
- Molecular formula:
- C4H8O
- IUPAC Name:
- butanal
- Details on test material:
- No information provided
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No information provided
Administration / exposure
- Route of administration:
- other: no data
- Vehicle:
- No information provided
- Details on exposure:
- No information provided
- Duration of treatment / exposure:
- No information provided
- Frequency of treatment:
- No information provided
- Post exposure period:
- No information provided
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Concentration range not specified
Basis:
no data
- No. of animals per sex per dose:
- No information provided
- Control animals:
- not specified
- Positive control(s):
- no data
Examinations
- Tissues and cell types examined:
- Bone marrow and erythrocytes
- Details of tissue and slide preparation:
- No information provided
- Evaluation criteria:
- No information provided
- Statistics:
- No information provided
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- not specified
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Results indicate that the test has low sensitivity for prediction of carcinogenicity, a convincingly positive result in this assay appears to be highly predictive of rodent carcinogenicity.
Any other information on results incl. tables
No additional information
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
The results indicate that the test has low sensitivity for prediction of carcinogenicity, a convincingly positive result in this assay appears to be highly predictive of rodent carcinogenicity. - Executive summary:
In a study conducted by Witt et al (2000) the mouse peripheral blood micronucleus (MN) test was performed on samples collected from 20 short-term, 67 sub-chronic and 5 chronic toxicity and carcinogenicity studies conducted by the National Toxicology Program (NTP). Data in this resport are presented for studies not previously published. The incidence on MN-PCE provided an index of damage induced within 72 hours of sampling whereas the incidence of MN in the NCE population at steady state provided an index of the average damage during the 30 -day period preceding sampling.
Data derived from peripheral blood MN analyses of dosed animals provided a useful indication of the in vivo potential for induced genetic damage and supply an important piece of evidence to be considered in the overall assessment of toxicity and health risk of a particular chemical. Although results indicated that the test has low sensitivity for prediction of carcinogenicity, a convincingly positive result in this assay appears to be highly predictive of rodent carcinogenicity.
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