Capsicum annuum, ext.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Examination of Chili Pepper and Nutmeg Oleoresins Using the Salmonela / Mammalian Microsome Mutagenicity Assay

Author:

Buchanan R L

Year:

1981

Bibliographic source:

Journal of Food Science, 47, 330-333.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Capsicum annuum, ext.

EC Number:

283-403-6

EC Name:

Capsicum annuum, ext.

Cas Number:

84625-29-6

Molecular formula:

Not available since an UVBC substance.

IUPAC Name:

Capsicum annuum, ext.

Test material form:

liquid

Method

Target gene:

Histidine-requiring gene in Salmonella typhimurium

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Type and composition of metabolic activation system:
- source of S9 : livers of rats induced with phenobarbital.
- concentration or volume of S9 mix in the final culture medium: 0.5 mL/plate

Test concentrations with justification for top dose:

2.5, 25, 250, 2500 and 25000 µg/plate.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO.

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Controls 2

Positive controls:

yes

Positive control substance:

other: N-methyl-N-nitro-N-nitrosoguanidine and picrolinic acid

Remarks:

Without metabolic activation.

Controls 3

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

Remarks:

With metabolic activation.

Details on test system and experimental conditions:

NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 4
- Number of independent experiments: 1

METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Not specified.
- Test substance added in agar (plate incorporation) at a level of 0.5 mL/plate.

TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 hr at 37ºC.

METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test substance chili pepper oleoresin was found as no mutagenic in a Salmonella / mammalian microsome mutagenicity assay.

Executive summary:

The test substance chili pepper oleoresin was tested for in vitro mutagenicity using the Salmonella / mammalian microsome mutagenicity assay similar to OECD Guideline 471. The experiments were performed with at least four replications, using Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1538 in the presence and absence of metabolic activation (S9 fraction prepared from the livers of rats). The test item was formulated in 0.1 mL DMSO as vehicle and concentrations of 2.5, 25, 250, 2500 and 25000 µg/plate were used in the assay. Vehicle control and appropriate positive controls (N-methyl-N-nitro-N-nitrosoguanidine and picrolinic acid without metabolic activation and 2-acetylamino-flourene with metabolic activation) were tested simultaneously. The test substance did not produce an increased reversion rate, while negative and positive controls were within expected ranges. These data indicates that the test substance is not mutagenic.