Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated

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:

1999-08-04 to 1999-08-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is regarded as relible without restrictions because it was conducted in compliance with GLP regulation and guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

26 May 1983

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Off. J. Europ. Commun., EEC-Directive 92/69, L383A, Annex V, B.14. Salmonella typhimurium- Reverse Mutation Assay, dated December 29, 1992

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

61791-19-3

Cas Number:

61791-19-3

IUPAC Name:

61791-19-3

Test material form:

other: liquid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

- Type and identity of media: Standard I nutrient broth for microbiology
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Details on mammalian cell type (if applicable):

- Type and identity of media: Standard I nutrient broth for microbiology
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

First experiment: 8, 40, 200, 1000, 5000 µg/plate
Second experiment: without S9-mix: 1.6, 8, 40, 200, 1000 µg/plate
Second experiment: with S9-mix: 1, 3, 10, 30, 90 µg/plate

Vehicle / solvent:

- Vehicle used: ethanole
- Justification for choice of vehicle: The solution medium was chosen according to the solubility properties.

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 100, TA 1535 without S9-mix

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537 without S9-mix

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine

Remarks:

TA 98, TA 1538 without S9-mix

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

all strains with S9-mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

EXPOSURE DURATION: 48 hours

NUMBER OF REPLICATIONS: 2

DETERMINATION OF CYTOTOXICITY: cloning efficiency

Evaluation criteria:

A combination of the following criteria was considered as a positive result:
- The plate background on non-reverted bacteria did not show any growth reduction versus the respective negative control.
- The spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range.
- As a rule, the positve controls showed mutation rates exceeding the control values of TA 100 an least by the factor of 2.0 and those of the other tester strains at least by the factor of 3.0.
- At more than one dose tested, the test substance caused at least a 2.0-fold increase in comparison with the negative xontrols in the tester strain TA 100. For the other tester strains, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positive.

Statistics:

not required

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 1535, TA1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no

COMPARISON WITH HISTORICAL CONTROL DATA: Yes, valid.

ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxic effects were noted at the concentration of 40 µg/plate or higher.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.