Registration Dossier
Registration Dossier
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EC number: 616-894-6 | CAS number: 8006-82-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 for 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 sensitization potential of black pepper oil on 25 human volunteers.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- 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.
- 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)
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 25 human volunteers were used
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: Not specified
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% in petrolatum
- Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: Not specified
- Vehicle:
- petrolatum
- Concentration / amount:
- Not specified
- Day(s)/duration:
- Not speccified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25 human volunteers were used
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No positive sensitization reaction observed
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No positive sensitization reaction observed
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Black pepper oil was applied on 25 human volunteers in the concentration 4% in petrolatum. No positive skin reaction were observed. Hence, Black pepper oil was considered not sensitizing to human skin.
- Executive summary:
Black pepper oil was used as a test material to evaluate it’s skin sensitization potential on 25 human volunteers.Black pepper oil was applied in the concentration of 4% in petrolatum . No positive skin reaction were observed. Hence, Black pepper oil was considered not sensitizing to human skin.
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