Dodecylamine

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:

weight of evidence

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Amines, coco alkyl

EC Number:

262-977-1

EC Name:

Amines, coco alkyl

Cas Number:

61788-46-3

IUPAC Name:

61788-46-3

Constituent 2

Reference substance name:

Coco Alkylamines

IUPAC Name:

Coco Alkylamines

Details on test material:

- Name of test material (as cited in study report): Genamin CC 100 D

Method

Target gene:

Histidine (S. typhimurium)
Tryptophan (E. coli)

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

4, 20, 100, 500, 2500, 10000 µg/plate (first experiment)
0.16, 0.8, 4, 20, 100, 500 µg/plate (second experiment)

Vehicle / solvent:

- Vehicle/solvent used: acetone

Controls

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: - S9: Sodium azide (TA 100, TA 1535), 9-Aminoacridine (TA 1537), 2-Nitrofluorene (TA98, TA 1538), N-Methyl-N-nitro-N-nitrosoguanidine (WP2 uvrA); +S9: Benzo(a)pyrene, 2-Aminoanthracene (all strains)

Results and discussion

Test results

Species / strain:

other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

The test item was tested for its mutagenic potential in 5 Salmonella typhimurium strains (TA 98, TA 100, TA 1535, TA 1537, TA 1538) and 1 Escherichia coli strain (WP2 uvr A). The test substance proved to be very toxic to the strains at 20 µg/plate and to form precipitations at 500 µg/plate, the highest concentration tested in the second experiment.

Either with or without metabolic activation, the substance was not mutagenic in the present test system.

Applicant's summary and conclusion

Conclusions:

Based on the study results it is concluded that the test material is not mutagenic in the bacterial test systems investigated either in the absence or in the presence of an exogenous metabolizing system (S-9).

Executive summary:

An investigation on induction of gene mutations in bacteria (OECD 471) was performed with coco alkylamines ("Genamin CC 100 D"). The test compound (purity approx. 100%) was solved in acetone and tested in doses of 0.16µg/plate up to 10 mg/plate with and without liver S-9 mix from Arochlor induced male Sprague Dawley rats. Only doses up to 100 µg/plate could be evaluated due to strain specific strong cytotoxic effects at doses of 20 or 100 µg/plate and higher doses. In TA1537 the bacterial background lawn was reduced already at 4µg/plate in the second experiment. Precipitaions were seen at 500 µg/plate and higher doses. No increases in the number of revertants were induced in any of the tester strains, e.g. Salmonella typhimurium TA100, TA1535, TA1537, TA1538, TA98 and E. coli WP2uvrA. Summarizing it can be stated that the test article genamin CC 100 D is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.