Registration Dossier
Registration Dossier
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EC number: 218-817-8 | CAS number: 2243-62-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD study or GLP defined.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
- Principles of method if other than guideline:
- Method: other: Acute toxicity: oral, rat
- GLP compliance:
- not specified
- Test type:
- other: Acute toxicity: oral; rat
- Limit test:
- no
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: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Lutrol
- Doses:
- 500; 550; 600; 800; 1000; 1500 mg/kg bw.
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- not specified
Results and discussion
Effect levels
- Dose descriptor:
- LD50
- Effect level:
- 634 mg/kg bw
- Mortality:
- see: remarks on results
- Clinical signs:
- see:remarks on results
- Body weight:
- see:remarks on results
Any other information on results incl. tables
Mortality and symptoms:
| Dose (mg/kg bw.) | Sex | No. of mortalities | No. of animals with symptoms | No. of animals used | Timepoint of death | Start of symptoms | Diminuated general condition | Narcosis | Rough hair | loss of bw.after one week |
| 500 | female | 0 | 0 | 10 | ||||||
| 550 | female | 2 | 10 | 10 | 3 -6d | 2h | + | + | + | + |
| 600 | female | 7 | 10 | 10 | 24h-5d | 2h | + | + | + | + |
| 800 | female | 9 | 10 | 10 | 24h-2d | 2h | + | + | + | + |
| 1000 | female | 9 | 10 | 10 | 2 -3d | 2h | + | + | + | + |
| 1500 | female | 10 | 10 | 10 | 4h-2d | 2h | + | + | + | + |
Applicant's summary and conclusion
- Executive summary:
Female Wistar rats were treated by gavage with one single dose of the test substance Alphamin ( 500; 550; 600; 800; 1000; 1500 mg/kg bw.).
10 rats per dose group were treated and observed for 14 days.
Following symptoms were observed: narcosis, rough hair, diminuated general condition, weight loss after the first week of experiment.
No macroscopical pathological findings were observed in the authopsy.
The LD50 was 634 mg/kg bw.
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