Alcohols, C16-18 and C18-unsatd., propoxylated

Endpoint summary

Additional information

In vitro genotoxicity studies were performed with Alcohols, C16-18 (even numbered) and C18 unsaturated, propoxylated, < 2.5 PO (CAS 70955-07-6).

Mutagenicity in bacteria

Mutagenicity in bacteria was assessed in a study performed with Alcohols, C16-18 (even numbered) and C18 unsaturated, propoxylated, < 2.5 PO (CAS 70955-07-6) according to OECD Guideline 471 and under GLP conditions (Woitkowiak, 2012). Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and E.coli strain WP2 were treated using the plate incorporation method as well as the preincubation method, both with and without the addition of a rat liver S9-mix. Concentrations tested were 33, 100, 333, 1000, 2500 and 5000 µg/plate. All tests were done in triplicates. The vehicle (acetone) and negative (untreated) control plates produced counts of revertant colonies within an acceptable range. All positive controls used in the test induced marked increases in the frequency of revertant colonies, both with and without the metabolising system. A reproducible mutagenic activity of the test material to any of the tester strains was not observed with and without metabolic metabolic activation. Precipitation of the test substance was observed from 2500μg/plate onward with and without S9 mix.

Thus, under the conditions of this test the test substance can be regarded as not mutagenic in bacteria.

Mutagenicity in mammalian cells 

The mutagenic potential in mammalian cells was assessed with Alcohols, C16-18 (even numbered) and C18 unsaturated, propoxylated, < 2.5 PO (CAS 70955-07-6) by a HPRT-assay according to OECD Guideline 476 and under GLP conditions (Wolny, 2013).In the first experiment Chinese hamster lung fibroblasts (V79) were exposed for 4 h to 2.5, 5.0, 10.0, 20.0, 40.0 and 60.0 µg/mL test substance in the absence and 2.5, 5.0, 10.0, 20.0, 40.0, 80.0, and 120 µg/mL test substance in the presence of metabolic activation. In the second experiment the cells were exposed for 24 h (without metabolic activation) and 4 h (with metabolic activation) to 2.5, 5.0, 10.0, 20.0, 40.0 and 60.0 µg/mL test substance. Positive and vehicle (ethanol) control cultures were included in each assay. Cytotoxicity was observed in the first (4 h) and the second experiment (24 h) at concentrations at 40 µg/mL without metabolic activation. No increased number of chromosome aberrations in the presence or absence of metabolic activation was observed at any concentration tested. Appropriate reference mutagens used as positive controls showed a significant increase in chromosome aberrations, thus indicating the sensitivity of the assay, and the efficacy of the S9-mix. Hence, the test substance is not clastogenic.

Genotoxicity in mammalian cells 

The clastogenic potential was assessed in a chromosomal aberration test with Alcohols C16-18 (even numbered) and C18 unsaturated, propoxylated, < 2.5 PO (CAS 70955-07-6) in mammalian cells according to OECD Guideline 473in five independent experiments where two parallel cultures were set up, according to the following scheme:

	Without S9 mix			With S9 mix
	Exp. IA	Exp.IIA		Exp. IB and IC	Exp. IIA and IIB
Exposure period	4h	18 h		4 h	4h
Recovery	14 h	--	--	14 h	24 h
Preparation interval	18 h	18 h	28 h	18 h	28 h

 

100 metaphases per culture were evaluated for structural chromosome aberrations. For the positive controls in Experiment IIA and IIB after 28 hours preparation interval with metabolic, only 50 metaphases were evaluated.

The highest applied concentration (5.2µL/mL) was chosen with regard to the purity (96.6%) of the test item and the recommended top dose.

The concentration selection for the cytogenicity experiments was performed considering the toxicity data of a pre-experiment.

In experiment IA in the absence of metabolic activation and in Experiment IC in the presence of metabolic activation, cytotoxicity indicated as reduced mitotic index was observed at the highest evaluated concentration (49.7, 45. 3% of control, respectively).

No clastogenicity was observed at concentrations evaluated either with or without metabolic activation. No relevant increase in polyploid metaphases was observed after treatment with the test item in comparison with the control cultures.

Positive controls (EMS and CPA) induced significant increases with structural chromosome aberrations.

In conclusion, under the experimental conditions of the study, the test item did not induce structural chromosome aberrations in V79 cells in vitro.

Summary

Alcohols, C16-18 (even numbered) and C18 unsaturated, propoxylated, < 2.5 PO (CAS 70955-07-6) is regarded as non-genotoxic.

 

Justification for selection of genetic toxicity endpoint
No study selected as all results are negative.

Short description of key information:
Ames (OECD 471): not mutagenic in bacteria
Chromosomal Aberration (OECD 473): not clastogenic in mammalian cells
HPRT (OECD 476): not mutagenic in mammalian cells

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the substance does not need to be classified for genotoxicity.