p-propylanisole

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Study of Artifical Flavouring Substances for Mutagenicity in the Salmonella / Microsome, Basc and micronucleus Tests

Author:

Wild, D., King, M.-T., Gocke, E. and Eckhardt, K.

Year:

1982

Bibliographic source:

Fd. Chem. Toxic

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

p-propylanisole

EC Number:

203-203-4

EC Name:

p-propylanisole

Cas Number:

104-45-0

Molecular formula:

C10H14O

IUPAC Name:

1-methoxy-4-propylbenzene

Specific details on test material used for the study:

No details reported.

Method

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA 1538, TA 98)

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

Five doses of the test item were tested (up to 3.6 mg/plate) in all five tester strains with and without S9 mix. No further details on dose concentrations were reported.

Vehicle / solvent:

No details on the vehicle for the test item used in this study are reported. However, it is noted that If the test item was found to be soluble, then water was used as the vehicle. Otherwise dimethylsulphoxide (DMSO) was used as a solvent for test chemcials that were poorly soluble in water.

Details on test system and experimental conditions:

METHOD OF APPLICATION: The Ames test was perfomed in Volger-Bonner medium according to a standard plate procedure.

DURATION
- Preincubation period:48 hours
- Exposure duration: No details reported
- Expression time (cells in growth medium):No details reported
- Selection time (if incubation with a selection agent):No details reported
- Fixation time (start of exposure up to fixation or harvest of cells):No details reported

SELECTION AGENT (mutation assays):No details reported

NUMBER OF REPLICATIONS: Each chemical was tested at least twice. No further details reported.

METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED:No details reported

NUMBER OF CELLS EVALUATED: Overnight bacterial cultures had cell titres of at least 10^9 cells/ml. No further details reported.

CRITERIA FOR MICRONUCLEUS IDENTIFICATION:

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No details reported.
- Any supplementary information relevant to cytotoxicity: No details reported

Rationale for test conditions:

No details reported

Evaluation criteria:

No details reported.

Statistics:

Statistical significance was determined according to the methods of Kastenbaum & Bowman. Test items that produced reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency were regarded as positive. Test items producing reproducible, dose-related and significant (P <0.01) but less than two-fold elevations were classified as marginally mutagenic under the experimental conditions.

Results and discussion

Test results

Key result

Species / strain:

other: TA 1535, TA 100, TA 1357, TA 1358, TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test item was found to be 'genetically inactive' in the Ames test. Therefore, the test item is considered to be negative for mutagenicity.

Executive summary:

The test item was found to be 'genetically inactive' in the Ames test. Therefore, the test item is considered to be negative for mutagenicity, according to CLP criteria (EC Regulation 1272/2008).