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

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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:

other: Acceptable, well-documented study report which meets basic scientific principles. No test with S.typhimurium TA102 and/or E.coli; limited exposure concentration.

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)

Deviations:

not specified

GLP compliance:

no

Remarks:

Pre-GLP study.

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

IUPAC Name:

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

Constituent 2

Reference substance name:

Adipic acid, compound with hexane-1,6-diamine

IUPAC Name:

Adipic acid, compound with hexane-1,6-diamine

Details on test material:

- Name of test material (as cited in study report): AH Salz (Hexamethylene diaminadipate)
- Analytical purity: ca. 100%
- Storage condition of test material: 4°C
No further data

The justification of the read-accross is fully detailed in the endpoint summary.

Method

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

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Cyclophosphamide, 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 REPLICATESS: 4 plates per dose and control

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

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

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 (migrated information):
negative (with and without metabolic activation).

Under the test conditions, 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.

Executive summary:

In a reverse gene mutation assay in bacteria, performed similarly to the OECD No. 471 guideline, AH salt was tested in five Salmonella strains (TA 1535, TA 1537, TA 1538, TA 98, TA 100) both in the presence and in the absence of metabolic activation (liver S-9 mix) using the direct incorporation method (four plates per concentration for each strain) at 4, 20, 100, 500, 2500 µg/plate.

The positive controls induced appropriate responses in the corresponding strains.

Under the test conditions of this study, AH salt was not mutagenic in the Ames test up to 2500 µg/plate tested.

By analogy, sebacic acid, compound with hexane-1,6 -diamine, is considered negative in Ames test.