Registration Dossier
Registration Dossier
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EC number: 205-182-7 | CAS number: 135-19-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.08.1986 - 10.09.1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 12.05.1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2-naphthol
- EC Number:
- 205-182-7
- EC Name:
- 2-naphthol
- Cas Number:
- 135-19-3
- Molecular formula:
- C10H8O
- IUPAC Name:
- 2-naphthol
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- age of the animals at the test beginning:
male rats: 7 weeks
female rats: 8 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Oleum Sesami, Ph. Eur. III
- Details on oral exposure:
- 1250 mg/kg bw: concentration in sesame oil: 25%, administration volume: 5 ml/kg b.w.
1600 mg/kg bw: concentration in sesame oil: 25%, administration volume: 6 and 4 ml/kg b.w.
2000 mg/kg bw: concentration in sesame oil: 25%, administration volume: 8 ml/kg b.w.
2500 mg/kg bw: concentration in sesame oil: 25%, administration volume: 10 ml/kg b.w. - Doses:
- 1250 mg/kg bw, 1600 mg/kg bw, 2000 mg/kg bw, 2500 mg/kg bw
- No. of animals per sex per dose:
- 10 (5 male, 5 female)
- Control animals:
- not specified
- Details on study design:
- observation period after administration: 14 d
- Statistics:
- LD50, 95% CL and the equation of the probit straight line were determined via probit analysis from different lethality rates.
Results and discussion
- Preliminary study:
- In preliminary tests the doses to be further investigated were found to be 1600 - 2500 mg/kg b.w.
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 426 - <= 1 710
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 340 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 469 - <= 1 750
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 320 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 728 - <= 1 560
- Mortality:
- Lethality occured until day 3 after administration.
- Clinical signs:
- other: The following clinical signs have been observed at the day of administration: decreased spontaneous activity, squatting position, prone / lateral position, irregular breathing, respiratory rales, narrowed palpebral fissure and bristled fur. In higher dose
- Gross pathology:
- The macroscopic examination of the died male and female animals revealed the following cahracteristics:
- blood vessels of the gastrointestinal tract considerably injected
- stomach and small intestine filled with substance remains
- stomach inflated
- clotted blood in small intestine
- urinary bladder filled with brownish-gloomy liquid - Other findings:
- The killed animals at the end of the follow-up period were free of macroskopic visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- former R 22
- Conclusions:
- Based on LD50 values of 1340 mg/kg bw in female rats and 1300 mg/kg bw in male rats 2-naphthol was classified as harmful according to the criteria of EC Directive 83/467/CEE.
Based on these values the test item beta-naphthol has to be classified as harmful according to CLP-regulation. - Executive summary:
In an assay according to OECD TG 401 on the acute oral toxicity of beta-naphthol the following values for the LD50 were determined:
For male and female animals: 1320 mg/kg bw (wistar rats)
For male animals: 1300 mg/kg bw (wistar rats)
For female animals: 1340 mg/kg bw (wistar rats)
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