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Toxicological information

Skin sensitisation

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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:
1963
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

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.
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: 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.