Dimethyl isophthalate

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: Similar to guideline protocol, not GLP

Data source

Reference

Reference Type:

publication

Title:

Genotoxicity Study of Dimethyl Isophthalate in Bacterial and Mammalian Cell System

Author:

Chung, YS, Chol S, Hong E-K, Ryu JC, Lee E and Choi K

Year:

2007

Bibliographic source:

Molecular and Cellular Toxicology 3(1), 53-59, 2007.

Materials and methods

Test guideline

Qualifier:

equivalent or similar 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:

Dimethyl isophthalate

EC Number:

215-951-9

EC Name:

Dimethyl isophthalate

Cas Number:

1459-93-4

Molecular formula:

C10H10O4

IUPAC Name:

1,3-dimethyl benzene-1,3-dicarboxylate

Test material form:

not specified

Details on test material:

purchased from the Fluka Company. No information on purity

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9 postmitochondrial supernatant fraction purchased from Molecular Toxicology, Inc.

Test concentrations with justification for top dose:

from 156.3 to 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 100 and TA 1535, without S9

Controls 2

Positive controls:

yes

Positive control substance:

other: 2-aminofluorene

Remarks:

WP2 without S9

Controls 3

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA 98 without S9

Controls 4

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537 without S9

Controls 5

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

Remarks:

all strains, with S9

Details on test system and experimental conditions:

Master strains were checked for characteristics, spontaneious reversion rate representing amino acid requirement, ampicillin resistance for R-factor and sensitivity to crystal violet for rfa membrance mutation and to UV for DNA repair.
METHOD OF APPLICATION: plate incorporation. Each of the tester strains, with or without tha addition of S9 mix, was incubated in a shaking incubator for 30 min at 37 degrees C and then the mixture was combined with top agar containing a minimal amount of histidine or tryptophan and then poured onto the surface of a sterile petri dish containing solidified bottom agar.
- Exposure duration: 48 h.
NUMBER OF REPLICATIONS: plated and assessed in triplicate
DETERMINATION OF CYTOTOXICITY:
- Method: no information on background lawn growth/survival

Evaluation criteria:

no data

Statistics:

mean and standard deviation of frequency of revertants

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The frequency of revertant colonies for any of the bacterial strains, with any dose of DMIP, either with or without metabolic activation, was not increased.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

All positive and negative controls were valid.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Dimethyl isophthalate was tested for bacterial mutagenicity in a plate incorporation assay in a protocol performed similar to OECD 471. In all five strains of bacteria, there was no increased incidence of revertants. The substance is evaluated as non-mutagenic