Formaldehyde, oligomeric reaction products with phenol

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

CONTRIBUTION OF COFFEE AROMA CONSTITUENTS TO THE MUTAGENICITY OF COFFEE

Author:

H. U. AESCHBACHER

Year:

1989

Bibliographic source:

FOOD CHEM. TOXICOL.

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:

To evaluate the mutagenic potential of test chemical in Salmonella typhimurium strain TA 98,TA 100 and TA 102 by AMES assay.9 TA98,

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Guaiacol

EC Number:

201-964-7

EC Name:

Guaiacol

Cas Number:

90-05-1

Molecular formula:

C7H8O2

IUPAC Name:

2-Methoxyphenol

Details on test material:

Details on test material
- Name of test material (as cited in study report): Guaiacol
-- Molecular formula ;C7H8O2
-- Molecular weight ;124.13g/mol

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 98,TA 100 and TA 102

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 prepared by using Aroclor 1254-induced rat liver.

Test concentrations with justification for top dose:

0.009-900mmol

Vehicle / solvent:

Methanol

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Methanol

True negative controls:

not specified

Positive controls:

yes

Remarks:

2-nitrofluorene, sodium azide, mitomycinC, 2-aminofluorene

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: Preincubation Method
DURATION
- Preincubation period:
- Exposure duration: 3 days

Rationale for test conditions:

Not specified

Evaluation criteria:

Mutation factors (MF) (induced/spontaneous revertants) were calculated at the dose levels that give the greatest effect.

Statistics:

Yes ,Mean ±Standard deviation was observed.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 98,TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: No mutagenic effct were observed.

Applicant's summary and conclusion

Conclusions:

Test chemical was evaluated for its mutagenic potential in Salmonella typhimurium TA 98, TA 100 and TA 102 by AMES test. The test result was considered to be negative in all strain in the presence and absence of metabolic activation S9.

Executive summary:

Genetic toxicity in vitro study was assessed for test chemical. The test material was exposed to Salmonella typhimurium TA 98, TA 100 and TA 102 in the presence and absence of metabolic activation S9by Preincubation method. The test chemical was exposed at the concentration of0.009-900mmol. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non mutagenic in Salmonella typhimurium TA 98, TA 100 and TA 102 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.