Registration Dossier
Registration Dossier
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EC number: 274-828-8 | CAS number: 70729-65-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- EC Number:
- 274-828-8
- EC Name:
- Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Cas Number:
- 70729-65-6
- Molecular formula:
- C22H24N6O9
- IUPAC Name:
- methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g (paste, moistened with distilled water)
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 1 square inch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, removal only
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS
24 h, 48 h, 72 h
SCORING SYSTEM:
- Method of calculation: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Remarks on result:
- not determinable
- Remarks:
- red staining of skin caused by test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- An assessment of any erythematous reaction following application of the test material could not be made as the test material stained the application site red. No signs of oedema were observed throughout the study. At the end of the study the application sites were submitted for
histopathological examination which revealed no obvious evidence of an inflammatory reaction. On the basis of the histopathological findings and the lack of oedematous reaction the test material is considered unlikely to be an irritant to rabbit skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results in an in vivo study with 3 rabbits, the substance is determined as not irritating to skin.
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