Glycerides, tallow sesqui-, hydrogenated, propoxylated

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 November 2015 to 28 January 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

in vitro mammalian cell micronucleus test

Test material

Test material information

1

Reference substance name:

Glycerides, tallow sesqui-, hydrogenated, propoxylated

EC Number:

614-598-1

Cas Number:

68553-12-8

Molecular formula:

n/a

IUPAC Name:

Glycerides, tallow sesqui-, hydrogenated, propoxylated

Method

Test concentrations with justification for top dose:

Preliminary toxicity test: 20.16, 33.59, 55.99, 93.31, 155.52, 259.2, 432, 720, 1200 and 2000 µg/mL.

The maximum final concentration tested in the preliminary toxicity test was 2000 µg/mL as this is the standard limit concentration within this test system as recommended in the regulatory guidelines.

Main tests:
-S9 mix (3 hours) 20, 40, 60, 80 and 100 µg/mL
+S9 mix (3 hours) 20, 40, 60, 80 and 100 µg/mL
-S9 mix (21 hours) 20, 40, 60, 80 and 100 µg/mL

The top dose was based on the results of the preliminary test in which precipitate was evident at 100 µg/mL.

Vehicle / solvent:

Ethanol

Controls

Negative solvent / vehicle controls:

yes

Remarks:

Ethanol

Positive controls:

yes

Positive control substance:

cyclophosphamide

mitomycin C

Evaluation criteria:

The following criteria were applied for assessment of assay acceptability:
The concurrent vehicle control was considered acceptable for addition to the laboratories historical vehicle control database (lie within or close to the 95%
confidence interval).
Concurrent positive controls induced a response that were compatible with the laboratories historical positive control database and produced statistically significant increases compared with the concurrent vehicle control.

The test was considered to be clearly positive and able to induce chromosome breaks if, in any of the experimental conditions examined:
At least one of the test concentrations exhibited a statistically significant increase compared with the concurrent vehicle control.
The increase was dose-related when evaluated with an appropriate trend test.
Any of the results were outside the distribution of the historical negative control data.

Providing that all of the acceptance criteria have been met, a negative response was claimed if, in all of the experimental conditions examined:
None of the test concentrations exhibited a statistically significant increase compared with the concurrent negative control.
There was no concentration-related increase when evaluated with an appropriate trend test.
All results were inside the distribution of the historical negative control data.

Results and discussion

Test results

Key result

Species / strain:

lymphocytes: Human

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

It is concluded that the substance has shown no evidence of causing biologically relevant increases in the frequency of structural chromosome aberrations under any treatment conditions employed in this study.

Executive summary:

In an in vitro chromosome aberration test human lymphocyes were exposed to the test substance in the presence and absence of metabolic activation. The substance did not show any evidence of causing biologically relevant increases in the frequency of structural chromosome aberrations under any treatment conditions employed in this study. Statistically significant increases in numerical aberrations in the form of polyploidy were observed in the absence of S9 mix following treatments for 3 and 21 hours in the absence of S9 mix in this in vitro cytogenetic test system, under the experimental conditions described.