Registration Dossier
Registration Dossier
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EC number: 204-327-1 | CAS number: 119-47-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study (OECD TG 404)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
- EC Number:
- 204-327-1
- EC Name:
- 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
- Cas Number:
- 119-47-1
- Molecular formula:
- C23H32O2
- IUPAC Name:
- 2-tert-butyl-6-[(3-tert-butyl-2-hydroxy-5-methylphenyl)methyl]-4-methylphenol
- Details on test material:
- RALOX 46, batch number: 95041
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h
- Number of animals:
- 3 (2 males, 1 female)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: no effcts
- Remarks on result:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
Any other information on results incl. tables
Very slight erythema (grad 1) was noted at one treated skin site at the 1-hour observation. No dermal reactions were noted at the 24, 48 and 72 -hours observations.
The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labeling regulations
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- The test material, RALOX 46, produced a primary irritation of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effcts were noted.
- Executive summary:
The test material, RALOX 46, produced a primary irritation of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effcts were noted.
The test material did not meet the critera for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.
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