Registration Dossier
Registration Dossier
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EC number: 616-894-6 | CAS number: 8006-82-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 iis from peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance raw material monograph for Black Pepper Oil
- Author:
- D.L.J Opdyke
- Year:
- 1 963
- Bibliographic source:
- Food and Cosmetics Toxicology. V.19, 1963
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To evaluate skin irritation potential of Black Pepper Oil on back of hairless mice.
- GLP compliance:
- not specified
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: 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)
Test animals
- Species:
- mouse
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Not specified
- Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 24 hrs
- Number of animals:
- Not specified
- Details on study design:
- Not specified
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No positive skin reaction were observed
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- Black pepper oil when applied on the back of hairless mice in undiluted form for 24 hrs showed no skin reactions. Hence , Black pepper oil was considered to be not irritating to the skin of mice.
- Executive summary:
Black pepper oil was used as a test material to evaluate its skin irritation potential. Black pepper oil when applied on the back of hairless mice in undiluted for 24 hrs showed no skin reactions. Hence , Black pepper oil was considered to be not irritating to the skin of mice.
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