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Toxicological information

Acute Toxicity: dermal

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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:
1978
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

Constituent 1
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)
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.