2,2-dimethylpropane-1,3-diyl dibenzoate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethylpropane-1,3-diyl dibenzoate

EC Number:

224-081-9

EC Name:

2,2-dimethylpropane-1,3-diyl dibenzoate

Cas Number:

4196-89-8

Molecular formula:

C19H20O4

IUPAC Name:

3-(benzoyloxy)-2,2-dimethylpropyl benzoate

impurity 1

Reference substance name:

3-hydroxy-2,2-dimethylpropyl benzoate

Cas Number:

5522-92-9

Molecular formula:

C12H16O3

IUPAC Name:

3-hydroxy-2,2-dimethylpropyl benzoate

Test material form:

solid: crystalline

Details on test material:

Batch No.: GSOH 140121

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

prepared from the livers of Aroclor 1254-induced male Sprague-Dawley rats

Test concentrations with justification for top dose:

Plate incorporation and preincubation methodoloy with and without S9-mix: 0, 50, 160, 500, 1600, 5000µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

other: 2-aminoanthracene; Mitomycin C for Salmonella typhimuriumTA102 in plate incorporation trials; Cumene for Salmonella typhimurium TA102 in preincubation trials

Details on test system and experimental conditions:

Preincubation method and plate incorporation method

Evaluation criteria:

A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA1535, TA100, TA1537 and TA98 this increase should be about twice that of solvent controls. For TA102 an increase of about 100 mutants should be reached. Otherwise the result is evaluated as negative.

Statistics:

no data

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Remarks:

of 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

Executive summary:

2,2-Dimethylpropane-1,3-diyl dibenzoate was investigated for point mutagenic effects in the Salmonella/microsome test (plate incorporation test and preincubation method). The test item was dissolved in DMSO and was administered in doses of up to and including 5000 µg/plate without and with S9 mix on the five Salmonella typhimurium LT2 mutant strains TA 1535, TA100, TA1537, TA98 and TA102 according OECD TG 471 under GLP conditions.

Doses up to and including 5000 µg/plate did not cause any bacteriotoxic effects. Substance precipitation occurred at the concentration of 5000 µg/plate. Evidence of mutagenic activity of the test item was not seen. No biologically relevant increase in the mutant count in comparison to the solvent controls was observed in any of the strains tested without and with S9 mix, in the plate incorporation as well as in the preincubation modification under the experimental conditions applied.

The employed positive controls had a marked mutagenic effect as was seen by a biologically relevant increase in mutant colonies compared to the corresponding solvent controls.

Therefore, 2,2-dimethylpropane-1,3-diyl dibenzoate was considered to be negative (non-mutagenic) without and with S9 mix in the plate incorporation as well as in the preincucation modification of the Salmonella/microsome test.