Registration Dossier
Registration Dossier
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EC number: 616-894-6 | CAS number: 8006-82-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is fron peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Monographs on Fragrance Raw Materials :Black pepper oil
- Author:
- D. L. J. Opdyke
- Year:
- 1 978
- Bibliographic source:
- Food and Cosmetics Toxicology,Volume 16, Supplement 1, 1978, Pages 651-652
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute dermal toxicity test was carried out to study the effects of Black Pepper Oil (8006-82-4)on rabbits.
- GLP compliance:
- not specified
- Test type:
- other: no data available
- Limit test:
- no
Test material
- Reference substance name:
- Essential Oil of Piper nigrum L. (Family: Piperaceae). Obtained by the steam distillation of dried unripe berries.
- EC Number:
- 616-894-6
- Cas Number:
- 8006-82-4
- IUPAC Name:
- Essential Oil of Piper nigrum L. (Family: Piperaceae). Obtained by the steam distillation of dried unripe berries.
- Test material form:
- liquid - liquid: emulsion
- Details on test material:
- - Name of test material: Black Pepper Oil
- IUPAC name: Pepper, black, oil (Piper nigrum L.)
- Molecular formula: Unspecified
- Molecular weight: Unspecified
- Smiles : Unspecified
- Inchl: Unspecified
- Substance type: Organic
- Physical state: Liquid (colorless to slightly greenish)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Black Pepper Oil
- Molecular formula :No data available
- Molecular weight :No data available
- Substance type:organic
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Type of coverage:
- other: dermal
- Vehicle:
- not specified
- Details on dermal exposure:
- No data available
- Duration of exposure:
- No data available
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed in treated rabbits at 5000 mg/kg bw
- Mortality:
- No mortality was observed in treated rabbits at 5000 mg/kg bw
- Clinical signs:
- No data available
- Body weight:
- No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The lethal concentration (LD50) value for acute dermal toxicity test was considered to be >5000 mg/kg bw ,when rabbits were treated with Black Pepper Oil (8006-82-4) by dermal application.
- Executive summary:
Acute dermal toxicity study was done in rabbits using test material Black Pepper Oil (8006-82-4).No mortality was observed at dose 5000 mg/kg bw. Hence,LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with Black Pepper Oil (8006-82-4)by dermal application.
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