Registration Dossier
Registration Dossier
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EC number: 201-855-4 | CAS number: 88-74-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study report, acceptable for assessment with restrictions (solid substance tested undiluted without moistering, no individual irritation scores given)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- Patch test according to the method described in § 1500.41 in the Federal Register 38, No. 187, 27 Sep 1973, page 27019 (Draize test).
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-nitroaniline
- EC Number:
- 201-855-4
- EC Name:
- 2-nitroaniline
- Cas Number:
- 88-74-4
- Molecular formula:
- C6H6N2O2
- IUPAC Name:
- 2-nitroaniline
- Details on test material:
- - Name of test material (as cited in study report): Echtorange GR Base = 2-nitro-1-aminobenzol
- Analytical purity: 98.5-99.5% base
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: SPF-Albino-Himalayan rabbits, Hoe:HIMK (SPFWiga)
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: 1/cage
- Diet (ad libitum): Erka 8300 (Robert Koch oHG/Hamm, Germany)
- Water (ad libitum): tap water
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, abraded and non-abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: the test substance was applied to a gauze patch that was applied to the skin by means of adhesive tape, covered by PVC foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: Draize scoring system (Federal Register§ 1500.41 in the Federal Register 38, No. 187, 27 Sep 1973, page 27019)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24-48-72 hrs
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: no skin irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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