Registration Dossier
Registration Dossier
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EC number: 203-148-6 | CAS number: 103-82-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- The Freund's Complete Adjuvant Test and the Open Epicutaneous Test for the given test chemical.
- Author:
- G. Klecak
- Year:
- 1 985
- Bibliographic source:
- Curr. Probl. Derm.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41)
- Principles of method if other than guideline:
- A preliminary irritation test was performed on guinea pigs to determine the maximum non-irritating concentration for the Open Epicutaneous tesrt
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Phenylacetic acid
- EC Number:
- 203-148-6
- EC Name:
- Phenylacetic acid
- Cas Number:
- 103-82-2
- Molecular formula:
- C8H8O2
- IUPAC Name:
- phenylacetic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material: Benzeneacetic acid
- Molecular formula: C8H8O2
- Molecular weight: 136.149 g/mole
- Smiles : c1(ccccc1)CC(O)=O
- Inchl: 1S/C8H8O2/c9-8(10)6-7-4-2-1-3-5-7/h1-5H,6H2,(H,9,10)
- Substance type: Organic
- Physical state: solid
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 300-450g
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: ethanol, acetone, H20, petroleum, PEG and/or other suitable vehicles
- Amount / concentration applied:
- 0.025 ml of each test concentration (e.g, 100, 30, 10 and 3%) in ethanol, acetone, H20, petroleum, PEG and/or other suitable vehicles
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 hours
- Number of animals:
- 6
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure: flanks
- % coverage: areas measuring 2 cm2 of the flank skin
- Type of wrap if used: no data available
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available
SCORING SYSTEM: no data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed in the 24 hours observation period
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- No signs of irritation were observed in the 24 hours observation period.
Hence, the test chemical was considered to be not irritating to guinea pig skin. - Executive summary:
A preliminary irritation test was performed on guinea pigs to determine the maximum non-irritating concentration for the Open Epicutaneous test. 6-8 male/female guinea pigs were used for the study.
0.025 ml of each test concentration (e.g, 100, 30, 10 and 3%) inethanol, acetone, H20, petroleum, PEG and/or other suitable vehicles was applied to theone of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp.Reactions are read 24 h after the application of the test material.The minimal irritating and the maximal nonirritating concentrations were determined by an all-or-none criterion. The minimal irritating concentration is defined as thelowest one causing skin irritation. The maximal nonirritating concentration is defined as the highest one not causing macroscopic skin reactions in any of the animals.
No signs of irritation were observed in the 24 hours observation period.
Hence, the test chemical was considered to be not irritating to guinea pig skin.
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