Fatty acids, C9, hexaesters with dipentaerythritol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

EC Number:

267-021-7

EC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Cas Number:

67762-52-1

Molecular formula:

Not defined because UVCB

IUPAC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Test material form:

liquid: viscous

Details on test material:

Sample Date: 01/23/2007
LOT: GA7412
Kinematic Visc.@100³C, cSt 19.0
Kinematic Visc.@40³C, cSt 214
Flash Point, ³C, Open cup 292

Method

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:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

the doses tested in the mutagenicity assay were selected based on the results of a dose range finding study using tester strains TA100 and WP2uvrA and ten doses of test article ranging from 6.67 to 5000 microg per plate, one plate per dose, both in the presence and absence of S9 mix.
Since no cytotoxicity was observed on the dose range finding study, the highest dose level of test article used in the mutagenicity assay was the same as the hihest dose tested in the range finding

The doses tested were 33.3, 100, 333, 1000, 3330, and 5000 microg per plate.

Vehicle / solvent:

ethanol

Controls

Controls 1

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

2-nitrofluorene

sodium azide

benzo(a)pyrene

other: 2-aminoanthracene

Controls 2

Positive control substance:

other: ICR-191

Results and discussion

Test results

Test results 1

Key result

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:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Key result

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:

not applicable

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Under the study conditions of the Ames assay, the test substance was not mutagenic with or without metabolic activation.

Executive summary:

A study was conducted to evaluate the mutagenicity of the test substance according to OECD 471, in compliance with GLP. The tester strains used were Salmonella typhimirium TA98, TA100, TA1535 and TA1537, as well as Escherichia coli WP2uvra. The assay was conducted with 6 concentrations of the substance (33.3, 100, 333, 1000, 3330 and 5000 µg/plate) in both the presence and absence of Arochlor-induced rat liver S9 mix, along with concurrent vehicle and positive controls, using three plates per dose. The results of the initial mutagenicity assay were confirmed in an independent experiment. Under the study conditions, the test substance did not cause a positive increase in the mean number of revertants per plate in any of the tester strains, either in the presence or the absence of S9 mix, and was therefore considered to be non-mutagenic (Mecchi, 2008).