Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

- no strains with an AT base pair at the primary reversion site (E. coli WP2 strains or S. typhimurium TA 102) were used to detect cross-linking mutagens

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

- no strains with an AT base pair at the primary reversion site (E. coli WP2 strains or S. typhimurium TA 102) were used to detect cross-linking mutagens

GLP compliance:

yes

Remarks:

deviation: no data were available on complete chemical characterization of the test substance

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

EC Number:

295-714-4

EC Name:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

Cas Number:

92128-22-8

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction products of tall-oil fatty acids and (3-aminopropyl)dimethylamine

Test material form:

liquid

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 mix from Aroclor 1254 induced rat livers

Test concentrations with justification for top dose:

16, 50, 158, 500, 1581, 5000 µg/plate (plate incorporation test);
1, 2, 4, 8, 16, 32, 64 µg/plate (preincubation test)

Vehicle / solvent:

Solvents used: deionized water (test substance), DMSO (positive controls)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide, nitrofurantoin and 4-nitro-1,2-phenylene diamine were only used without S9 mix and 2-aminoanthracene was only used with S9 mix

Details on test system and experimental conditions:

METHOD: Standard plate test and preincubation test

Evaluation criteria:

A reproducible and dose-related increase in mutant counts (at least twice the amount of vehicle controls) of at least one strain of bacteria is considered to be a positive result

Statistics:

not specified

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: strong strain-specific bacteriotoxic effects at 16 µg/plate and above (plate incorporation test) and weak, strain-specific bacteriotoxic effects at 8 µg/plate (preincubation test)

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

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

The test substance was initially investigated using the Salmonella/ microsome plate incorporation test for point mutagenic effects in doses of up to and including 5000 µg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

Doses up to and including 8 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used to a limited extent up to and including 64 µg per plate for assessment purposes. Substance precipitation occurred at the dose 1581 µg per plate and above.

Evidence of mutagenic activity of the test substance was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.

The test substance was investigated in an independent repeat using the Salmonella/microsome test for point mutagenic effects in doses up to 64 µg per tube after preincubation for 20 minutes at 37 °C on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

Doses up to and including 4 µg per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had only a weak, strain-specific bacteriotoxic effect. Due to the weakness of this effect this range could nevertheless be used for assessment purposes.

Evidence of mutagenic activity of the test substance was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.

The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.

Therefore, the test substance was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

In an Ames test according to OECD TG 471 with the Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 the test substance revealed no mutagenic activity in the absence and in the presence of a metabolic activation system.