Registration Dossier
Registration Dossier
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EC number: 221-573-5 | CAS number: 3147-75-9
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:
- other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity, occlusive conditions, 24 h exposure)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation, occlusive treatment, 24 h exposure, no scoring at 48 h))
- Principles of method if other than guideline:
- 6 rabbits were treated with 0.5 g of the test substance, prepared as paste with diethyl succinate, for 24 h under occlusive conditions. The test sites were shaved before treatment. The test substance was applied to intact as well as to abraded skin. Scoring was recorded 24 h and 72 h after application (Draize Test).
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol
- EC Number:
- 221-573-5
- EC Name:
- 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol
- Cas Number:
- 3147-75-9
- Molecular formula:
- C20H25N3O
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-4-(2,4,4-trimethylpentan-2-yl)phenol
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: diethyl succinate
- Controls:
- other: untreated site served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- no data
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: no data
- Type of wrap if used: impervious patch
REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 24 h
SCORING SYSTEM: according to the Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact and abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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