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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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.