Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine

EC Number:

273-601-0

EC Name:

Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine

Cas Number:

68990-47-6

Molecular formula:

The substance is a UVCB substance. One of the most likely and the smallest molecule arising from the reaction process is assumed to be: C18H33O. C18H31O. 2C4H12N3 . C4H2O2

IUPAC Name:

Reaction product of 2,5-Furandione with reaction products of tall-oil fatty acids, diethylenetriamine, triethylenetetramine and tetraethylenepentamine

Details on test material:

Test substance: Polyamide
CAS No. : 68990-47-6
Stored: at ambient temperature in the dark

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 97

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 102

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 1535

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0.08, 0.1, 0.3, 0.8, 1, 3 and 5 mg/plate in the initial assay
0.03, 0.08, 0.1, 0.3, 0.8, 1, 3 and 5 mg/plate in the repeat assay

Vehicle / solvent:

Polyamide 1M2P

Controls

Untreated negative controls:

yes

Remarks:

3 plates containing only minimal media and tester strains

Negative solvent / vehicle controls:

yes

Remarks:

100 µl of DMSO or 1M2P and tester strain

Positive controls:

yes

Positive control substance:

other: In the presence of S9: 2-aminofluorene in TA98, 2-aminoanthracene in TA100 and TA1535, Danthron in TA102. In the absence of S9 ICR-191 was used in TA97, 2-nitrofluorene in TA98, NaN3 in TA100 and TA1535, mitomycin-c in TA102.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at >3 mg/plate in absence of S9 and at 5 mg/plate in presence of S9

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 98

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

Test results 3

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at >3 mg/plate in absence of S9 and at >1 mg/plate in presence of S9

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5 mg/plate in the initial assay and at 3 mg/plate in the repeat assay, in absence of S9. At > 3 mg/plate in presence of S9.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 1535

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

Applicant's summary and conclusion

Conclusions:

There was no evidence of an increase in the number of revertant colonies that exceeded twice background in any of the five tester strains examined at dose levels up to 5 mg/plate in the presence or absence of a metabolic activation source (S9). The lack of a mutagenic response indicates fatty acid, tall oil, reaction products with diethylenetriamine, maleic anydride, tetraetyhlenpentamine and triethylenetetramine is non-genotoxic in tester strains TA97a, TA98, TA100, TA102 and TA1535 under the conditions employed. Based on these results, the test substance is not likely to be carcinogenic.

Executive summary:

The test substance fatty acid, tall oil, reaction products with diethylenetriamine, maleic anhadride, tetraetyhlenpentamine and triethylenetetramine was assessed for bacterial mutagenicity in an Ames-Test (OECD 471, GLP). Five tester strains (TA97a, TA98, TA100, TA102 and TA1535) were used, validated with negative (solvent control) and positive controls, with and without metabolic activation. Concentration tested were up to 5 mg/plate.

For none of the tester strains a positive response in revertant colonies was found, neither with nor without metabolic activation and thus, the test substance was found negative inducing mutations in any of the strains tested.