Registration Dossier
Registration Dossier
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EC number: 212-990-3 | CAS number: 903-19-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17-20 Oct 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.4
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted 28 Jul 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Good Laboratory Practice, The United Kingdom Compliance Programme, Department of Health & Social Security 1986 and subsequent revision, Department of Health 1989.
Test material
- Reference substance name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- EC Number:
- 212-990-3
- EC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Cas Number:
- 903-19-5
- Molecular formula:
- C22H38O2
- IUPAC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd., Margate, Kent, UK
- Age at study initiation: 13-15 wks
- Weight at study initiation: 3.0-3.5 kg (range)
- Housing: individually, in plastic cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet, ad libitum
- Water: drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~19
- Humidity (%): 30-70
- Air changes (per hr): ~19
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 17 Oct 1995 To: 20 Oct 1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: neat, as Sponsor supplied - Duration of treatment / exposure:
- 4 h
Reading time points: 1, 24, 48 and 72 h - Observation period:
- Day 1 approximately 60 min after removal of the dressings, 24, 48 and 72 h after exposure ended.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: test substance was applied on the dorso-lumbar region under a 25 mm x 25 mm gauze pad moistened with 0.5 mL of distilled water.
- % coverage: not specified.
- Type of wrap if used: Elastoplast elastic adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water (30 to 40°C)
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
- Day 1 approximately 60 min after removal of the dressings, then 24, 48 and 72 h after exposure to test substance ended.
SCORING SYSTEM:
- Method of calculation: numerical system ranking scores for both oedema and erythema at each evaluation (similar to Draize evaluation).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No numerical response to treatment was observed in any animal at any time throughout the observation period. The individual and mean erythema score at 24/48/72 h was 0.0 in 3 of 3 animals. The individual and mean edema score at 24/48/72 h was 0.0 in 3 of 3 animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
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