5-Thiazolecarboxylic acid, 2-(4-hydroxyphenyl)-4-methyl-, ethyl ester

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:

31/05/2011-01/07/2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

“Notification based on Article 57-2-1 (current article 57-3-1) of the Industrial Safety and Health Law (Ordinance No. 57, 1972)” (Notification No. 77, September 1, 1988; partially revised No. 67, June 2, 1997 and No. 120, December 25, 2000), “Partial revision of the standard for safety assessment” (Notification No. 413, June 2, 1997), “Revision of the report format for Mutagenicity tests using microorganisms” (Notification No. 653, September 29, 1997), and “Materials and methods and evaluation of the results of Mutagenicity tests using microorganisms” (liaison on February 8, 1999).

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

ethyl 2-(4-hydroxyphenyl)-4-methyl-1,3-thiazole-5-carboxylate

EC Number:

605-268-8

Cas Number:

161797-99-5

Molecular formula:

C13H14ClNO3S

IUPAC Name:

ethyl 2-(4-hydroxyphenyl)-4-methyl-1,3-thiazole-5-carboxylate

Test material form:

solid: crystalline

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium, other: TA100, TA1535, TA98 and TA1537

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Details on mammalian cell type (if applicable):

The Escherichia coli strain was obtained from the National Institute of Hygienic Science (the present National Institute of Health Sciences) in Japan on March 16, 1983.

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2-Aminoanthracene; 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide

Evaluation criteria:

The results were considered to be positive when the mean number of revertant colonies on the plates treated with the test substance increased by twofold or more as compared with that in the negative control group, and the increase was reproducible or dose-dependent.
No statistical analysis was performed for the evaluation.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA100, TA1535, TA98 and TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

In conclusion, Manufacturing Intermediate of TMX-67 (Thiazole Derivative (Free Base Form)) was negative for mutagenicity under the conditions employed in this study.