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EC number: 221-297-5 | CAS number: 3058-38-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- purity of test substance; acclimation period, details on test animals and housing/feeding conditions not reported; 24 h exposure period, occlusive dressing used, observation at 24 and 72 h only, full reversibility not observed
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In a dermal irritation study, test substance was dermally applied on the intact or abraded side surface of 6 New Zealand White rabbits. Test sites were covered with an occlusive dressing for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- 2,4,6-trinitrobenzene-1,3,5-triamine
- EC Number:
- 221-297-5
- EC Name:
- 2,4,6-trinitrobenzene-1,3,5-triamine
- Cas Number:
- 3058-38-6
- Molecular formula:
- C6H6N6O6
- IUPAC Name:
- trinitrobenzene-1,3,5-triamine
- Test material form:
- not specified
- Details on test material:
- - Name of test material as cited in the report: TATB ; 1,3,5-triamino-2,4,6-trinitrobenzene
- Lot/batch No.of test material: B-318
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and unabraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours after application of test substance
- Number of animals:
- 6 animals
- Details on study design:
- TEST SITE
- Area of exposure: The back of each rabbits were clipped free of hair 24 hour before application of the test substance. Two sites were abraded and two were unabraded. The test substance was applied to the test site.
- Type of wrap if used: The test sites were covered with a gauze pad and the entire back was overwrapped with rubber dam.
REMOVAL OF TEST SUBSTANCE
- 24 hours later, the wraps were removed and excess test substance was removed and each test site was scored for erythema and edema.
OBSERVATION TIME POINTS
24 and 72 hours after application of test substance
SCORING SYSTEM:
- Method of calculation: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 0.04
- Remarks on result:
- other: primary irritation score
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- Test substance caused a minimum amount of edema in one of the six treated rabbits at the 24-hour reading only. The total primary irritation score was 0.04.
- Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was non-irritating to skin of rabbits, therefore it is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a dermal irritation study, 0.5 g of test substance was dermally applied on the intact or abraded side surface of 6 New Zealand White rabbits. Test sites were covered with an occlusive dressing for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch.
Test substance caused a minimum amount of edema in one of the six treated rabbits at the 24-hour reading only. The total primary irritation score was 0.04.
Reversibility was not assessed.
Under the test conditions, the test substance was non-irritating to skin of rabbits, therefore it is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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