Registration Dossier
Registration Dossier
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EC number: 222-179-6 | CAS number: 3378-72-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 July 1987 to 3 August 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under concurrent standards of quality assurance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-(tert-butyl)benzylamine
- EC Number:
- 222-179-6
- EC Name:
- N-(tert-butyl)benzylamine
- Cas Number:
- 3378-72-1
- Molecular formula:
- C11H17N
- IUPAC Name:
- N-(tert-butyl)benzylamine
- Test material form:
- liquid
- Details on test material:
- Distilled NBTB, N-Benzyl-tert-butylamine; N-(1,1-dimethylethyl) benzene-methanamine. Purity 99.3% (average). Liquid. Store at room temperature.
Constituent 1
- Specific details on test material used for the study:
- NBTB, batch 7200. Purity 98-101%.
In vitro test system
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- not required
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The New Zealand White rabbits were sourced from Buckmasters, Henham, Hertfordshire.
Age: 10-11 weeks.
Weight: 2.3 to 2.4 kg.
Rabbits were individually housed in metal cages with perforated floors
They had free access to tap water and SDS Rabbit Diet
Animal Room temperature was maintained at 19 degrees celcius
12 hours of light and 12 hours of darkness were given.
19 air changes per hour were given.
Humidity at 30-70%
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- Three
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- severe reaction with necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Severe reactions with necrosis were observed in all 3 animals, which persisted to day 14. One animal was found dead on day 12.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- A single semi-occlusive application of N-Benzyl-Tert-Butylamine to intact rabbit skin for four four hours elicited severe dermal irritation with persistent signs including necrosis..
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