Registration Dossier
Registration Dossier
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EC number: 202-588-6 | CAS number: 97-52-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-Studie
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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:
- 4-nitro-o-anisidine
- EC Number:
- 202-588-6
- EC Name:
- 4-nitro-o-anisidine
- Cas Number:
- 97-52-9
- Molecular formula:
- C7H8N2O3
- IUPAC Name:
- 2-methoxy-4-nitroaniline
- Reference substance name:
- PNOA
- IUPAC Name:
- PNOA
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,4 - 3.5 kg
- Housing: single animal
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: PEG 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per animal
- Concentration (if solution): 500mg / 0.25 ml PEG 400
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1 animal only showed effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 h
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not irritating
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