Registration Dossier
Registration Dossier
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EC number: 203-157-5 | CAS number: 103-90-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Effect of modifying agents on the phenotypic expression of cytochrome P-450, glutathione S-transferase molecular forms, microsomal epoxide hydrolase, glucose-6-phosphate dehydrogenase and γ-glutamyltranspeptidase in rat liver preneoplastic lesions
- Author:
- Tsuca, H. et al
- Year:
- 1 988
- Bibliographic source:
- Carcinogenesis (London) 1988, 9(4), 547-554.
- Reference Type:
- review article or handbook
- Title:
- Dose no.:P6
- Author:
- RSC Publishing
- Year:
- 2 011
- Bibliographic source:
- Dictionary of Substances and their effects (DOSE);Tsuca, H. et al Carcinogenesis (London) 1988, 9(4), 547-554.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Skin irritation toxicity of acetaminophen (paracetamol)on rats
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Paracetamol
- EC Number:
- 203-157-5
- EC Name:
- Paracetamol
- Cas Number:
- 103-90-2
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- .
- Details on test material:
- - Name of test material (as cited in study report): paracetamol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Inc., Atsugi, Japan
- Age at study initiation:6 weeks
- Weight at study initiation:
- Diet (e.g. ad libitum):basal diet (Oriental M, Oriental Yeast Co., Tokyo)
- Water (e.g. ad libitum):tap water ad libitum
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- week 32
- Number of animals:
- 40 animals ,four groups (five rats each)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- no data
- Remarks on result:
- other: Skin rashes have been reported
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The paracetamol (acetaminophen) caused minimal irritation in rats at a concentration of 1.3%.,Skin rashes have been reported by paracetamol.
- Executive summary:
The paracetamol (acetaminophen) caused minimal irritation in rats at a concentration of 1.3%.,Skin rashes have been reported by paracetamol.
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