2,3,6-trimethylphenol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,3,6-trimethylphenol

EC Number:

219-330-3

EC Name:

2,3,6-trimethylphenol

Cas Number:

2416-94-6

Molecular formula:

C9H12O

IUPAC Name:

2,3,6-trimethylphenol

Details on test material:

- Name of test material (as cited in study report): 2,3,6-Trimethylphenol
- Analytical purity: 99.4%
- Impurities (identity and concentrations): no data
- Storage condition of test material: room temperature
No further data.

Method

Target gene:

For Salmonella typhimurium strains, the amino acid histidine locus is the target gene.

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

rat liver S-9, induced with Aroclor 1254

Test concentrations with justification for top dose:

20 - 5000 µg/plate; see below

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitroso-guanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine; depending on strain and activation condition

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation;

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 2500 µg/plate (SPT); >= 1500 µg/plate (PIT)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

No increase in the number of revertants was observed with any tester strain under any test condition.

Bacteriotoxicity (indicated by reduced bacterial growth) was observed in the SPT at doses >= 2500 µg/plate and in the PIT at 1500 µg/plate.

The test substance was completely soluble in the vehicle chosen; no precipitation was noted at any concentration tested.

Applicant's summary and conclusion

Executive summary:

REPORT SUMMARY

The substance 2,3,6-Trimethylphenol was tested for mutagenicity in the Ames test.

Strains: TA 1535, TA 100, TA 1537, TA 98

Dose range: 20 µg - 5000 µg/plate (SPT; TA 100, TA 98)

4 µg - 2500 µg/plate (SPT; TA 1535, TA 1537)

4 µg - 1500 µg/plate (PIT; all tester strains )

Test conditions: Standard plate test ( SPT) and preincubation test ( PIT) both with and without metabolic activation (rat liver S-9 mix) .

Solubility: Complete solubility of the test substance in DMSO.

Toxicity: A bacteriotoxic effect was observed in the standard plate test at doses => 2500 µg/plate and in the preincubation test at 1500 µg/plate.

Mutagenicity: An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.

Assessment:

According to the results of the present study, the test substance 2,3,6-Trimethylphenol is not mutagenic in the Ames test under the experimental conditions chosen here.