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Diss Factsheets

Administrative data

Description of key information

Skin sensitization:

The skin sensitization potential of Black pepper oil was estimated using OECD QSAR toolbox v3.3 with logPow as the primary descriptor.

Black pepper oil was estimated to be not sensitizing to the skin of guinea pig.

Based on the estimated results, Black pepper can be considered to be not sensitizing to skin and can be classified under the category “Not Classified” as per CLP regulation

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
(Q)SAR
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
Justification for type of information:
Data is predicted using OECD QSAR toolbox version 3.3 and QMRF report has been attached
Qualifier:
according to guideline
Guideline:
other: estimated data
Principles of method if other than guideline:
Prediction was done by using OECD QSAR toolbox v3.3
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified
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)
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
other: Not specified
Vehicle:
not specified
Concentration / amount:
No data available
Day(s)/duration:
No data available
Adequacy of induction:
not specified
No.:
#1
Route:
other: Not specified
Vehicle:
not specified
Concentration / amount:
No data available
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
No data available
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
Dose level:
No data available
No. with + reactions:
0
Clinical observations:
no sensitization reaction estimated
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
No sensitization reaccction estimated

The prediction was based on dataset comprised from the following descriptors: "Skin Sensitisation"
Estimation method: Takes highest mode value from the 8 nearest neighbours
Domain  logical expression:Result: In Domain

((((((("a" or "b" or "c" )  and ("d" and ( not "e") )  )  and ("f" and ( not "g") )  )  and ("h" and ( not "i") )  )  and "j" )  and "k" )  and ("l" and "m" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Alkene OR Allyl OR Cycloalkene by Organic Functional groups ONLY

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Allyl OR Cycloalkene OR Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Aliphatic Carbon [CH] OR Aliphatic Carbon [-CH2-] OR Aliphatic Carbon [-CH3] OR Olefinic carbon [=CH- or =C<] OR Olefinic carbon [=CH2] OR Tertiary Carbon by Organic functional groups (US EPA) ONLY

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Non binder, without OH or NH2 group by Estrogen Receptor Binding

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as Non binder, MW>500 OR Non binder, non cyclic structure by Estrogen Receptor Binding

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as Group 14 - Carbon C by Chemical elements

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Group 16 - Oxygen O by Chemical elements

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as No functional group found by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Alkene by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Allyl AND Cycloalkene AND Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "k"

Referential boundary: The target chemical should be classified as Allyl AND Cycloalkene AND Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "l"

Parametric boundary:The target chemical should have a value of log Kow which is >= 2.96

Domain logical expression index: "m"

Parametric boundary:The target chemical should have a value of log Kow which is <= 6.12

Interpretation of results:
other: Not sensitizing
Conclusions:
Black pepper was considered to be not sensitizing to guinea pig skin
Executive summary:

The skin sensitization potential of Black pepper oil was estimated using OECD QSAR toolbox v3.3 with logPow as the primary descriptor.

Black pepper oil was estimated to be not sensitizing to the skin of guinea pig.

Based on the estimated results, Black pepper can be considered to be not sensitizing to skin and can be classified under the category “Not Classified” as per CLP regulation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization:

  In different studies, Black pepper oil has been investigated for potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with human data for target chemical Black pepper oil and its functionally similar read across substances 1-methyl-4(1-methylethylidene) cyclohex-1-ene (586-62-9) and Citrus aurantium var. amara (68916-04-1). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

    The skin sensitization potential of Black pepper oil was estimated using OECD QSAR toolbox v3.3 with logPow as the primary descriptor.

Black pepper oil was estimated to be not sensitizing to the skin of guinea pig. Based on the estimated results, Black pepper can be considered to be not sensitizing to skin and can be classified under the category “Not Classified” as per CLP regulation

The above estimated data was supported by experimental result summarized inFood and Cosmetics Toxicology. V.19, 1963 for the target.

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.

The above experimental result was supported by experimental data summarized in Food and Cosmetics Toxicology ,Volume 14, Supplement, 1976 for thefunctionally similar read across substances 1-methyl-4(1-methylethylidene) cyclohex-1-ene (586-62-9)

1-methyl-4(1-methylethylidene) cyclohex-1-ene was used as a test material to evaluate skin sensitization potential on 24 human volunteers. Test material was applied in the concentration of 20% in petrolatum on the human subjects. No positive skin reaction were observed. Hence, 1-methyl-4(1-methylethylidene) cyclohex-1-ene was considered not to be sensitizer to human skin. 

The above experimental result was further supported by experimental data summarized in Food and Cosmetics Toxicology ,Volume 12, 1974 for functionally similar read across substance Citrus aurantium var. amara (68916-04-1).

 Citrus aurantium var. amara was used as a test material to evaluate it’s skin sensitization potential on 25 human volunteers in the concentration 20% in petrolatum. No positive skin reaction was observed .Hence, Bitter orange oil was considered to be not sensitizing to human skin.

Based on the available data for the target and its closely related read across substances it can be concluded that Black pepper oil was  not sensitizing to skin ; and it can be classified under the category “Not classified ” as per CLP regulation.

 

 

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for the target and its closely related read across substances it can be concluded that Black pepper oil was  not sensitizing to skin ; and it can be classified under the category “Not classified ” as per CLP regulation.