Registration Dossier
Registration Dossier
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EC number: 203-398-6 | CAS number: 106-44-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: only one dose tested, no information on GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the genotoxicity of cresols using sister-chromatid exchange (SCE)
- Author:
- Cheng M and Kligerman AD
- Year:
- 1 984
- Bibliographic source:
- Mutation Res 137, 51-55 (1984)
Materials and methods
- Principles of method if other than guideline:
- p-Cresol was evaluated in an in vivo SCE assay.
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay
Test material
- Reference substance name:
- p-cresol
- EC Number:
- 203-398-6
- EC Name:
- p-cresol
- Cas Number:
- 106-44-5
- Molecular formula:
- C7H8O
- IUPAC Name:
- p-cresol
- Details on test material:
- Test substance: p-cresol, purity >99%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- DBA
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- no data
- Details on exposure:
- no data
- Duration of treatment / exposure:
- single dose
- Frequency of treatment:
- single application
- Post exposure period:
- ca, 21.5 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 75 mg/kg bw in sunflower oil
Basis:
nominal conc.
- No. of animals per sex per dose:
- 3 intact animals and 3 hepatoectomized animals.
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- bone marrow, alveolar macrophages, regenerating liver cells. 20 metaphases from 3 dishes were analyzed for each cell type from each animal.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The dose tested was overtly toxic to the mice, causing lethargy, piloerection and lacrimation.
The positive control was functional.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
- Executive summary:
p-Cresol was evaluated in an in vivo SCE assay. p-Cresol did not induce significant increases in SCE frequencies in any of the cell types examined: bone marrow cells, alveolar macrophages, liver cells. p-Cresol was negative under the condition of this assay.
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