Registration Dossier
Registration Dossier
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EC number: 218-817-8 | CAS number: 2243-62-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP defined.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,5-naphthylenediamine
- EC Number:
- 218-817-8
- EC Name:
- 1,5-naphthylenediamine
- Cas Number:
- 2243-62-1
- Molecular formula:
- C10H10N2
- IUPAC Name:
- 1,5-naphthylenediamine
- Details on test material:
- IUCLID4 Test substance: other TS: purity 98.9 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: experimental animals were also used as controls (the contralateral side was treated only with water
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3 animals
Results and discussion
In vivo
Results
- Irritation parameter:
- other: erythema and edema score (DRAIZE grade)
- Basis:
- mean
- Time point:
- other: 1,24,48,72h and 7, 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: no reddening or swelling observed. DRAIZE grade: 0
Any other information on results incl. tables
Skin Irritation/corrosion rabbit: expos.: 4h :
| Animal No: | b.w. | Sex | DRAIZE-grade after | Irritation factors | ||||||||||||||
| 1 h | 24 h | 48 h | 72 h | 7 d | 14 d | |||||||||||||
| E | Ö | E | Ö | E | Ö | E | Ö | E | Ö | E | Ö | E | Ö | |||||
| D79 | 3,2 kg | female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - | 0,0 | 0,0 | ||
| D80 | 3,7 kg | female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - | 0,0 | 0,0 | ||
| E92 | 3,2 kg | female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - | 0,0 | 0,0 | ||
E = erythema
Ö = edema
- = not tested
Applicant's summary and conclusion
- Executive summary:
The test substance was tested in a semiocclusive application of 500 mg/kg bw. in rabbits.
The exposure time was 4 h and the observation period 14 d.
No reddening or swelling of the tested skin region was observed. DRAIZE grade: 0
The test substance was not irritating or corrosive to the skin.
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