Registration Dossier
Registration Dossier
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EC number: 274-570-6 | CAS number: 70321-86-7
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 standards with acceptable restrictions - analytical purity of the test substance not indicated
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Federal Register, 38, No.187 §1500.41
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (14/10 hour dark/light rhythm, treatment on intact and abraded skin, occlusive treatment, 24 hour long treatment)
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol
- EC Number:
- 274-570-6
- EC Name:
- 2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol
- Cas Number:
- 70321-86-7
- Molecular formula:
- C30H29N3O
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-4,6-bis(2-phenylpropan-2-yl)phenol
- Test material form:
- solid
- Details on test material:
- - Name as cited in publication: 2 - [2' hydroxy - 3', 5' - bis- (alpha, aplha dimethylbenzyl) phenyl]-benzotriazole
- Batch number: A 16-234/5
- Analytical purity: no data
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: no data
- Batch No.: A 16-234/5
- pH: 6
Test animals
- Species:
- rabbit
- Strain:
- other: Himalayan breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Weight at study initiation: 1.5 - 2 kg.
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit food (NAFAG Gossau SG)
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14/10
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved (unabraded and abraded)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated parts of the same rabbit
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Scoring of skin irritation was performed 24 and 72 hours after initiation of treatment. - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Before treatment the entire back, and the flank of the rabbits were shaved and immediately before treatment, the shaven skin of the left side was slightly scarified. The right side was not scarified.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The patches were covered with an impermeable material and fastened with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 hours
SCORING SYSTEM: draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (unabraded skin)
- Basis:
- mean
- Remarks:
- (of all 6 animals)
- Time point:
- other: mean over 24, 48 and 72 hours after start of treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Remarks:
- (unabraded skin)
- Basis:
- mean
- Remarks:
- (of all 6 animals)
- Time point:
- other: mean over 24, 48 and 72 hours after start of treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- Effects on scarified skin 24 hours after start of exposure (6 animals)
- Erythema: 1 (animals # 1, 3, 5 and 6), 0 (animals # 2 and 4)
- Oedema: 0 (all animals)
Effects on scarified skin 48 hours after start of exposure (6 animals)
- Erythema: 1 (animal # 6), 0 (animals # 1 - 5)
- Oedema: 0 (all animals)
Effects on scarified skin 72 hours after start of exposure (6 animals)
- Erythema: 0 (all animals)
- Oedema: 0 (all animals)
Any other information on results incl. tables
In accordance with conventional practice, only results of the non scarified skin sections are adopted in the final assessment for skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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