Disodium adipate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP, short documentation, purity not specified, similar to TG471

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Reference 2

Reference Type:

publication

Title:

Bacterial mutagenicity testing of 49 food ingredients gives very few positive results.

Author:

Prival MJ, Simmon VF, Mortelmans KE

Year:

1991

Bibliographic source:

Mutat. Res. 260, 321-329.

Reference 3

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

The standard S. typhimurium plate-incorporation assay was performed. The S9 mix used as an in vitro metabolic activator system contained 10% Aroclor 1254-induced liver S9 from male  Sprague-Dawley rats. Each substance was tested in the presence and in the  absence of S9 mix. In addition the tryptophan requiring E. coli strain  WP2  was tested for reversion to tryptophan independance. This test was performed by the same procedure as the S. typhimurium assay except that agar was supplemented with Oxoid nutrient broth to provide a trace of tryptophan. All platings were performed in duplicates and all tests were repeated on a different day. Concurrent positive controls were run with each test. The results were considered valid only if the positive control compound  induced increase in mutant counts to at least twice  background. The  following positive control compounds were used in the absence of S9:  2-nitrofluorene (5 or 10 µg per plate) for S. typhimurium strains TA98  and TA1538; sodium azide (0.5 or 1 µg) for TA100 and TA1535;  9-aminoacridine (50 or 100 µg) for TA1537; and AF-2 (furylframide, 0.1  µg) or N-methyl-N'-nitro-N-nitrosoguanidine (ENNG) (10 µg) for E. coli.  2-Anthramine (1 to 10 µg) was the positive control compound requiring S9  metabolic activation used for all bacterial strains.

GLP compliance:

not specified

Type of assay:

bacterial reverse 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:

adipic acid

Details on test material:

Test substance: purity not specified

Method

Target gene:

S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100: histedine synthesis; Escherichia coli WP2 : tryptophan synthesis

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100, and Escherichia coli WP2

Metabolic activation:

with and without

Test concentrations with justification for top dose:

0.033, 0.10, 0.33, 1.0, 3.3 and 10 mg/plate

Details on test system and experimental conditions:

IUCLID4 Type: Ames test

Results and discussion

Test results

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100, and Escherichia coli WP2

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Adipic acid gave no evidence of mutagenicity in any of the
bacterial strains used. Negative and positive controls were functional.

Applicant's summary and conclusion

Executive summary:

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).