Registration Dossier
Registration Dossier
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EC number: 229-355-1 | CAS number: 6486-23-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 NOV 1976 to 26 NOV 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles.
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 (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
Test material
- Reference substance name:
- 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide
- EC Number:
- 229-355-1
- EC Name:
- 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide
- Cas Number:
- 6486-23-3
- Molecular formula:
- C16H12Cl2N4O4
- IUPAC Name:
- 2-[(4-chloro-2-nitrophenyl)diazenyl]-N-(2-chlorophenyl)-3-oxobutanamide
- Test material form:
- solid: nanoform, no surface treatment
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: mixed feed ERKA 8300 (Robert Koch, Hamm, Germany), ad libitum
- Water: tap water, ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped/intact or clipped/scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h after end of exposure
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- Type of wrap if used: PVC foil, elastic bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p. 27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.
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: intact and 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: intact and scarified
- Irritant / corrosive response data:
- Erythema and edema scores immediately after exposure were 0 as well as at later time points.
The same results were observed with scarified skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- 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, as no skin responses were observed in 6/6 animals 24 and 48 h after exposure, which lasted 20 h longer than required by OECD TG 404.
- 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 500 mg test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Neither erythema nor edema were noted 24 and 48 h after end of exposure. The test material is not irritating to skin under these test conditions.
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