Registration Dossier
Registration Dossier
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EC number: 258-221-5 | CAS number: 52846-56-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 07 SEP 1976 to 23 SEP 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: FDA guideline (minor deviations from OECD guideline)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal register 38, No. 187, 27.9.1973, p.27019)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
Test material
- Reference substance name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide
- EC Number:
- 258-221-5
- EC Name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide
- Cas Number:
- 52846-56-7
- Molecular formula:
- C17H14N6O5
- IUPAC Name:
- 2-[(4-nitrophenyl)diazenyl]-3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: single
- Diet: ERKA 8300 (Futtermittelwerke Robert Koch oHG, Hamm, Germany), ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped intact and clipped scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h after removal of patch with observation time points immediately, 24 h and 48 h after removal of the patch.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: erythema and edema scores (0-4)
Skin was evaluated immediately, 24 h and 48 h after removal of the patch. Mean values of the readings 24 and 48 h after removal are reported in the results table.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact and clipped scarified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact and clipped scarified
- Irritant / corrosive response data:
- Immediately after removal of patch no erythema score could be determined due to pigment overlay. Edema score at this time point was 0 for all animals. No edema or eryhthema were seen 24 and 48 h after removal of the patch (score 0).
Results on scarified skin showed identical results.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not irritating to skin under these test conditions.
This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements. - Executive summary:
The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Immediately after removal of patch no erythema score could be determined due to pigment overlay. No erythema were seen at the later observation time points. No edema were seen at any time point (score 0). The test item is not irritating under these test conditions.
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