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EC number: 229-177-4 | CAS number: 6422-99-7
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:
- 1 980
- 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
- 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)
- 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.
Constituent 1
Constituent 2
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.
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