Registration Dossier
Registration Dossier
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EC number: 202-803-3 | CAS number: 99-94-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- p-toluic acid
- EC Number:
- 202-803-3
- EC Name:
- p-toluic acid
- Cas Number:
- 99-94-5
- Molecular formula:
- C8H8O2
- IUPAC Name:
- 4-methylbenzoic acid
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle:
- Concentration of test material in vehicle:
- Amount of vehicle (if gavage or dermal):
- Type and concentration of dispersant aid (if powder):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- Twice with 24 hr interval
- Frequency of treatment:
- Twice with 24 hr interval
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- Micronuclei in red blood cells.from bone marrow.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Additional information on results:
- Although there are no ADME studies, it can be predicted, based on physical chemical considerations and toxicokinetic prediction, that the substance is likely to reach the target tissue, the bone marrow. Based on these results, p-toluic acid is not anticipated to be genotoxic in vivo.
Applicant's summary and conclusion
- Conclusions:
- Although there are no ADME studies, it can be predicted, based on physical chemical considerations and toxicokinetic prediction, that the substance is likely to reach the target tissue, the bone marrow. Based on these results, p-toluic acid is not anticipated to be genotoxic in vivo.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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