Essential Oil of Piper nigrum L. (Family: Piperaceae). Obtained by the steam distillation of dried unripe berries.

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

Ames test valuation of mutagenic activity in essences and spices.

Author:

U.S. National Library of Medicine

Year:

2017

Bibliographic source:

Toxicology Data Network, 2017

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Ames test was peformed to determine the mutagenic nature of Black pepper oil

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

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 the test material: Black Pepper Oil
- IUPAC name: Black Pepper Oil
- Molecular formula: Not specified
- Molecular weight: Not specified

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: Unspecified

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with

Metabolic activation system:

Mammalian microsomal activation

Test concentrations with justification for top dose:

No data

Vehicle / solvent:

No data

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

No data

Rationale for test conditions:

No data

Evaluation criteria:

The plates were observed for increase in the number of revertants/plate

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: Unspecified

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

Black pepper oil did not induce gene mutation in Salmonella typhimrium in the presence of mammalian microsomal activation and hence is not likely to classify as a gene mutant in vitro.

Executive summary:

Ames test was peformed to determine the mutagenic nature of Black pepper oil. The spices was exposed to mammalian microsomal activation and plated on Salmonella typhimurium. Black pepper oil did not induce gene mutation in Salmonella typhimrium in the presence of mammalian microsomal activation and hence is not likely to classify as a gene mutant in vitro.