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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethylpropane-1,3-diyl dibenzoate
EC Number:
EC Name:
2,2-dimethylpropane-1,3-diyl dibenzoate
Cas Number:
Molecular formula:
3-(benzoyloxy)-2,2-dimethylpropyl benzoate
impurity 1
Chemical structure
Reference substance name:
3-hydroxy-2,2-dimethylpropyl benzoate
Cas Number:
Molecular formula:
3-hydroxy-2,2-dimethylpropyl benzoate
Test material form:
solid: crystalline
Details on test material:
Batch No.: GSOH 140121


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:
Untreated negative controls:
True negative controls:
not specified
Positive controls:
Positive control substance:
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.
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
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
of 5000 µg/plate
Vehicle controls validity:
Untreated negative controls validity:
Positive controls validity:

Applicant's summary and conclusion

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.