Dipotassium adipate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Adipic acid

EC Number:

204-673-3

EC Name:

Adipic acid

Cas Number:

124-04-9

Molecular formula:

C6H10O4

IUPAC Name:

hexanedioic acid

Details on test material:

Content of adipic acid: 99.92%

Method

Target gene:

HPRT

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 liver microsomal fraction from male Wistar rats

Test concentrations with justification for top dose:

0.1, 0.25, 0.5, 1, 2.5, 5, 7.5 and 10 mM without metabolic activation
0.5, 0.75, 1, 2,5, 4, 7, 8.5 and 10 mM with metabolic activation

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

7,12-dimethylbenzanthracene

Results and discussion

Test results

Key result

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: strain/cell type: Chinese hamster lung fibroblasts (V79)

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

Adipic acid was investigated in an OECD TG 476 study in Chinese hamster V79 cells in the absence and in the presence of metabolic activator (S9) up to concentrations of 10 mM. No precipitation of the test item was noted in any experiment; no biological relevant growth inhibition was observed with and without metabolic activation. In both experiments no biologically relevant increase of mutants was found after treatment with the test item. DMBA and EMS were used as positive controls and showed distinct and biologically relevant effects in mutation frequencies.

In conclusion, adipic acid is considered to be non-mutagenic in the HPRT locus using V79 cells.