Registration Dossier
Registration Dossier
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EC number: 218-817-8 | CAS number: 2243-62-1
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- 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
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- other: Acute Inhalation Toxicity study
- 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:
- purity: 98.4 %; applied as dust (middle diameter of particles: 8.16, 8.63 µm resp.)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2010; 5270 mg/m³ air
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
Results and discussion
Effect levels
- Dose descriptor:
- LC50
- Effect level:
- >= 5.27 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- see: remarks on results
- Clinical signs:
- other: see: executive summary
- Body weight:
- The body weights of the animals in group 3 were diminuated in the observation period after experiment.
- Gross pathology:
- see: executive summary
Any other information on results incl. tables
Akute Inhalation Toxicity: dust
| No.of group | Concentration (mg/m³ air) | Toxicological result | duration of symptoms | Timepoint of death | Particle < 5 µm (%) | ||
| Rat male | |||||||
| 1 | Air-control | 0* | 0** | 10*** | -- | -- | -- |
| 2 | 2010 | 0 | 0 | 5 | -- | -- | 29 |
| 3 | 5270 | 0 | 5 | 5 | 4d-5d | -- | 26 |
| Rat female | |||||||
| 1 | Air-control | 0 | 0 | 10 | -- | -- | -- |
| 2 | 2010 | 0 | 0 | 5 | -- | -- | 29 |
| 3 | 5270 | 2 | 3 | 5 | 3d-6d | 4d | 26 |
*- Number of mortalities
**- Number of animals with symptoms
***- Number of animals used
LC50 male rat: > 5270 mg/m³ air
LC50- female rat: ca. 5270 mg/m³ air
Applicant's summary and conclusion
- Executive summary:
5 male and 5 female Wistar rats (170 -200g) per group were treated in an acute inhalation toxicity test with the test substance for 4 hours.
The observation period was 14 days.
Symptoms of toxicity observed were: reduced motility, decelerated breathing, ruffled hair (occurred in the second half of the first week of the observation period); 2 females died after 4 days; macroscopical findings in female rats: hydrothorax, reddened renal pelvis, dark and enlarged spleen, pale liver with marked lobules, reddened gastrointestinal tract.
The LC50 for male rats was > 5,27 mg/l.
The LC 50 for female rats was ca. 5,27 mg/l.
The NOEL was 2,01 mg/l.
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