Petrolatum (petroleum), oxidized, Bu ester

Endpoint summary

Additional information

In vitro data

Bacterial reverse mutation

The potential of the test material to cause gene mutation in bacterial strains was determined in a GLP study conducted in accordance with standardised guidelines OECD 471, EU Method B.13/14 and EPA OPPTS 870.5100. Four strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and one Escherichia coli strain (WP2P uvrA) were treated in the presence and absence of a rat liver derived metabolic activation system (S9 mix). In two separate assays, the test material did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the tester strains used in the assay either in the presence or in the absence of metabolic activation. The test material is therefore considered to be non-mutagenic to the bacterial tester strains used under the specific conditions of the assay.

Chromosome aberration

In a GLP compliant chromosome aberration study performed according to the standardised guidelines OECD 473, EU Method B.10 and UK department of Health Committee on Mutagenicity Guidelines for the Mutagenicity Testing of Chemicals, the test material was determined to be non-clastogenic. Under the conditions of the test the human lymphocyte did not produce a statistically significant increase in the frequency of cell aberrations in the absence or presence of metabolic activation. Therefore the test material is considered to be non-mutagenic.

Mammalian cell gene mutation

A GLP compliant study was performed according to the standardised guidelines OECD 476, EU Method B.17, US EPA OPPTS 870.5300, and would be acceptable to the Japanese METI/MHLW guidelines for testing of new chemical substances. The study was designed to assess the potential mutagenicity of the test material on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line, both in the absence and presence of metabolic activation (S9 mix). Under the conditions of the study the test material did not induce any toxicologically significant dose-related increases in the mutant frequency at any dose level, with or without metabolic activation, in either the first or the second experiment. Therefore the test material was considered to be non-mutagenic to L5178Y cells under the conditions of this assay.

All three studies were performed under GLP conditions and in accordance with standardised guidelines with a sufficient level of detail to assess the accuracy and reliability of the data. Since the Ames test was conducted with the registered substance it was assigned a reliability score of 1 according to the criteria of Klimisch (1997); the chromosome aberration test and mouse lymphoma assay were conducted with the read across substance, hydrocarbon waxes (petroleum), oxidised, and were assigned a reliability score of 2.

Justification for selection of genetic toxicity endpoint
As multiple studies are presented to address genetic toxicity, not one single study was selected as the key study as they represent different types of genetic toxicity and are therefore not comparable.

Short description of key information:
IN VITO DATA
Reverse mutation in bacteria: Negative (S. typhimurium strains TA 1537 TA 1535, TA 100 and TA98 and E. coli strain WP2 uvrA+/- metabolic activation), OECD 471, EU Method B.13/14, EPA OPPTS 870.5100, Vértesi (2012)

Chromosome aberration (hydrocarbon waxes (petroleum), oxidised): Negative (human lymphocytes) with and withou metabolic activation, OECD 473, EU Method B.10, Wright (2004)

Gene mutation in mammalian cells (hydrocarbon waxes (petroleum), oxidised): Negative (thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line) with and without metabolic activation, OECD 476m EU Method B.17, US EPA OPPTS 870.5300, Japanese METI/MHLW guidelines, Flanders (2012)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008 (CLP), and Directive 67/548/EEC (DSD),

the substance does not require classification for genetic toxicity based on the overall negative response noted in the available genetic toxicity studies.