Adipic acid, compound with hexane-1,6-diamine (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-01-15 to 1980-01-17 (experiment 1); 1980-02-02 to 1980-02-04 (experiment 2)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Adipic acid, compound with hexane-1,6-diamine (1:1)

EC Number:

222-037-3

EC Name:

Adipic acid, compound with hexane-1,6-diamine (1:1)

Cas Number:

3323-53-3

Molecular formula:

C6H16N2.C6H10O4

IUPAC Name:

hexanedioic acid - hexane-1,6-diamine (1:1)

Specific details on test material used for the study:

- Name of test material (as cited in study report): AH Salz (Hexamethylene diaminadipate)
- Analytical purity: ca. 100%
- Storage condition of test material: 4°C

Method

Target gene:

his

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S-9

Test concentrations with justification for top dose:

4, 20, 100, 500, 2500 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

cyclophosphamide

other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrososguanidine, 4-nitro-ophenylenediamine, 9-aminoacridinium chloride monohydratrate

Remarks:

positive control substance depending on the strain and activation condition

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h (37°C)

NUMBER OF REPLICATIONS: 4 plates per dose and control

NUMBER OF CELLS EVALUATED:

DETERMINATION OF CYTOTOXICITY
- Method: decreased his- background growth

OTHER:
For better evaluation, the test was repeated with tester strain TA 100 with metabolic activation, only.

Evaluation criteria:

In general, a test substance has to be judged as positive, if the following criteria are fulfilled:
- doubling of the spontaneous mutation rate (control),
- dose-response relationship,
- reproducibility of results.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

No mutagenic activity (increase in the number of his+ revertants) and no bacteriotoxicity (decreased his- background growth) was observed at any concentration with any tester strain both with and without metabolic activation. For details, see attached files.

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
negative

The substance, hexamethylenediamine adipate was not mutagenic in the Ames test, when assayed at concentrations of up to 2500 µg/plate in the presence and absence of metabolic activation and has not to be classified according to EU GHS classification and according to annex VI-Directive
67/548/EEC.