[No public or meaningful name is available]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 10 - July 27, 2010

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids C10-20, reaction product with diethylenetriamine

EC Number:

940-308-0

IUPAC Name:

Fatty acids C10-20, reaction product with diethylenetriamine

Test material form:

liquid: viscous

Details on test material:

Test material: Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Old name of the test material: MK195KSF
Sample description: orange/brown hazy solid
Volatile: no
Storage conditions: at room temperature

Method

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

Experiment I:
without metabolic activation:
1, 2, 4, 6, 8 and 10 μg/mL
with metabolic activation:
8, 10, 20, 40, 60, 80 and 100 μg/mL
Experiment II:
without metabolic activation:
0.031, 0.063, 0.125, 0.25, 0.5, 1, 2 and 4 μg/mL
with metabolic activation:
10, 20, 30, 40, 50 and 60 μg/mL

Controls

Untreated negative controls:

yes

Remarks:

cell culture medium (DMSO)

Positive controls:

yes

Remarks:

Without metabolic activation: EMS; Ethylmethanesulfonate. With metabolic activation: CPA; Cyclophosphamide

Results and discussion

Test results

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

In experiment I at 4ug/mL without S9 and at 40ug/mL with S9. In experiment II at >= 0.5ug/mL without S9 and at >= 50ug/mL with S9.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Precipitation:

In experiment I and II, precipitation of the test item was noted with metabolic activation at all the concentrations evaluated and without metabolic activation no precipitation was observed in both experiments.

Toxicity:

In experiment I without metabolic activation, toxic effects of the test item were noted at concentrations of 4 μg/mL and with metabolic activation at concentrations of 40 μg/mL.

In experiment II without metabolic activation, toxic effects of the test item were observed at concentrations of 0.5 μg/mL and higher. With metabolic activation, toxic effects of the test item were noted at concentrations of 50 μg/mL and higher.

Clastogenicity:

In both experiments, no biologically relevant increase of the aberration rates was noted after treatment with the test item with and without metabolic activation. The aberration rates of all dose groups treated with the test item were within the historical control data of the negative control.

Polyploid cells:

In the experiments I and II with and without metabolic activation no biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item as compared to the controls.

Applicant's summary and conclusion

Conclusions:

In conclusion, it can be stated that during the described in vitro chromosomal aberration test and under the experimental conditions reported, the substance did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line.
Therefore, Fatty acids, C10-20 neo, reaction products with diethylenetriamine is considered to be non-clastogenic.