Tetramethylammonium hydrogen phthalate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study has been performed according to OECD and/or EC guidelines and according to GLP principles. However, for studies performed with a substance analogue the maximum Klimisch rate is 2 (according to the REACH guideline). The rationale for read-across of these data is included in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Principles of method if other than guideline:

The test item Phthalic Anhydride was assessed for its potential to induce mutations at the HPRT locus using V79 cells of the Chinese Hamster.
The selection of the concentrations was based on data from the pre-experiments. In all experiments 10 mM was selected as the highest
concentration.
The test item was investigated at the following concentrations:
Experiment I
with metabolic activation: 0.10,0.25,0.5,1.0,2.5,5.0,7.5 and 10 mM
and without metabolic activation: 0.025,0.05,0.5, 1.0,2.5,5.0, 7.5 and 10 mM
Experiment II
without metabolic activation: 0.10,0.25,0.5,1.0,2.5,5.0,7.5 and 10 mM
and with metabolic activation: 1.0,1.75,2.5,4.0,5.5,7.0,8.5 and 10 mM

GLP compliance:

yes (incl. QA statement)

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Phthalic anhydride

EC Number:

201-607-5

EC Name:

Phthalic anhydride

Cas Number:

85-44-9

IUPAC Name:

2-benzofuran-1,3-dione

Details on test material:

- purity: > 99%
- EC name: Phtalic anhydride
- IUPAC name: 2-benzofuran-1,3-dione

Method

Target gene:

no data

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Experiment I
with metabolic activation: 0.10,0.25,0.5,1.0,2.5,5.0,7.5 and 10 mM
and without metabolic activation: 0.025,0.05,0.5, 1.0,2.5,5.0, 7.5 and 10 mM
Experiment II
without metabolic activation: 0.10,0.25,0.5,1.0,2.5,5.0,7.5 and 10 mM
and with metabolic activation: 1.0,1.75,2.5,4.0,5.5,7.0,8.5 and 10 mM

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: Ethylmethanesulfonate; 7,12-Dimethylbenz(a)anthracene

Results and discussion

Test results

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: V79cells

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

No precipitation of the test item was noted in the experiments.

No biologically relevant growth inhibition was observed in experiment I and II with and without metabolic activation with one exception. In experiment II without metabolic activation for the highest concentration evaluated (10 mM) the relative growth was 17.6%.

In both experiments no biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation). No dose-response relationship was observed.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance Phthalic Anhydride was assessed for its potential to induce mutations at the HPRT locus using V79 cells of the Chinese Hamster up to concentrations of 10 mM. The study was conducted according to the OECD guideline and according to GLP principles. The test substance was found to be not mutagenic in this test, with or without metabolic activation.