Registration Dossier
Registration Dossier
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EC number: 218-817-8 | CAS number: 2243-62-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
- Principles of method if other than guideline:
- Method: other: according to guideline 84/449/EWG, Amtsblatt der Europaeischen Gemeinschaften Nr. L251 vom 19.09.1984, 103
- GLP compliance:
- yes
- Test type:
- other: Acute toxicity: dermal, rat
- Limit test:
- yes
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:
- Purity 98.4 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Cremophor EL
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
Results and discussion
Effect levels
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortalities.
- Clinical signs:
- No systemic or local symptoms of toxicity were observed.
- Body weight:
- see: remarks on results
- Gross pathology:
- No patological-anatomical changes observed
Any other information on results incl. tables
Body weights in (g)
| Animal No: | Sex | Week |
||
| 0 | 1 | 2 | ||
| 1 | male | 270 | 286 | 295 |
| 2 | male | 263 | 267 | 281 |
| 3 | male | 244 | 255 | 276 |
| 4 | male | 250 | 285 | 284 |
| 5 | male | 240 | 284 | 267 |
| MW | 253 | 275 | 281 | |
| 6 | female | 199 | 185 | 200 |
| 7 | female | 198 | 199 | 205 |
| 8 | female | 199 | 214 | 216 |
| 9 | female | 192 | 194 | 190 |
| 10 | female | 198 | 193 | 204 |
| MW | 197 | 197 | 203 | |
MW= Media
Applicant's summary and conclusion
- Executive summary:
In an acute dermal toxicity study 5 male and 5 female Wistar-rats (median weight: 253; 197 g resp.) were treated with 2000 mg/kg of the test substance (in Cremophor EL). The application time was 24h and the observation period 14 days.
No systemic or local symptoms of toxicity were observed.
The LD 50 was > 2000 mg/kg bw.
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