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Genetic toxicity in vitro

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Reference
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
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
Target gene:
HPRT
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
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
7,12-dimethylbenzanthracene
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'.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Justification for selection of genetic toxicity endpoint

Adipic acid is considered to be non-mutagenic in the HPRT locus using V79 cells. Moreover, adipic acid was neither mutagenic nor cytotoxic in a study similar to OECD TG 471 in bacteria such as Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 or Escherichia coli WP2 up to concentrations of 10 mg/plate with or without metabolic activator S9 (Prival 1991).

Justification for classification or non-classification

The substance is not classified according to CLP-Regulation (EC) No 1272/2008. Potassium adipate will dissociate into potassium and adipate ions and hence can be regarded as a mixture of both constituent ions. The classification as hazardous to human health is therefore based on the classification of its moieties (K and adipic acid). Both potassium and adipic acid are not classified as mutagenic, and according to the summation method, it is concluded that potassium adipate is not classified as mutagenic.