2,3,5-trimethylhydroquinone

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with restriction. Test carried out with only four strains of Salmonella tyhimurium. A test with Salmonella tyohimurium TA102 or Escherichia coli WP2 uvrA was not carried out.

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)

Deviations:

yes

Remarks:

4 tester strains used

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,3,5-trimethylhydroquinone

EC Number:

211-838-3

EC Name:

2,3,5-trimethylhydroquinone

Cas Number:

700-13-0

Molecular formula:

C9H12O2

IUPAC Name:

2,3,5-trimethylbenzene-1,4-diol

Details on test material:

- Name of test material (as cited in study report): 2,3,6-Trimethylhydrochinon
- Test substance No.: 88/728
- Analytical purity: 99.5%
- Storage condition of test material: room temperature

Method

Target gene:

histidin operon

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9-mix

Test concentrations with justification for top dose:

1st experiment (standard plate test): TA 100, TA 98: 0, 20, 100, 500, 2500, 5000 µl/plate
2nd experiment (standard plate test): without S9 for all strains: 0, 0.8, 4, 20, 100, 500 µl/plate; with S9 for all strains: 0, 4, 20, 100, 500, 1500 µl/plate
3rd experiment (preincubation test): without S9 for all strains: 0, 0.4, 2, 10, 50, 100 µl/plate; with S9 for all strains: 0, 4, 20, 100, 250, 500 µl/plate

Vehicle / solvent:

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

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene; 10 µg/plate in DMSO; for TA 100, TA 98, TA 1535, TA 1537

Remarks:

with metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG); 5 µg/plate in DMSO; for TA 100, TA 1535

Remarks:

without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine; 10 µg/plate in DMSO; for TA 98

Remarks:

without metabolic activation

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without metabolic activation

Migrated to IUCLID6: 100 µg/plate in DMSO; TA 1537

Details on test system and experimental conditions:

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


DURATION
- Preincubation period: 20 min, 37°C
- Exposure duration: 48 h, 37°C

NUMBER OF REPLICATIONS: 3

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

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:

other: in the standard plate test: > 100µg (without S-9 mix) or > 1500 µg (with S-9 mix); in the preincubation test: > 100 µg (without S-9 mix) or no cytotoxicity (with S-9 mix)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

Solubility : Complete solubility of the test substance in DMSO.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.