Hydrocarbon waxes (petroleum), oxidized

Endpoint summary

Additional information

All three of the key studies have been assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch (1997). They all demonstrated that the test substance does not have a potential to induce genetic toxicity.

A supporting Ames study was also available (Anonymous, 2000a). This study was assigned a Klimisch reliability score of 2. It found the test substance was not mutagenic to S. typhimurium TA 98 in the presence of metabolic activation, agreeing with the findings from the key study.

A supporting IP 346/80 Assay (Anonymous, 2000b) gave a positive result for carcinogenicity. 34.7% of DMSO-extractable material was produced in the study, which according to the criteria set out in the study means the test material is considered to be mutagenic and requires classification accordingly. The data is reported as an abstract with incomplete recording of the methodology followed; it is not possible to assess the accuracy of the information. There is no standard guideline followed and with very limited methodological information, it is not possible to use this study to classify the material. On this basis, the study is disregarded.

A further two supporting Ames tests have been included (Cinelli, 2008a and 2000b), the results of which were both in agreement with the key study. Both studies were assigned a Klimisch score of 1. The test material was administered to five bacterial strains, S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2uvrA, in the presence and absence of metabolic activation using both the plate incorporation and pre-incubation methods. Under the conditions of each test the test material was found to be non-mutagenic in all strains tested.

A mouse lymphoma study (Getuli, 2008), has also been provided as supporting information, results of which are in agreement with the key study. Under the conditions of the test, the test material did not induce mutation at the TK locus of L5178Y mouse lymphoma cells in vitro in the absence or presence of S9 metabolic activation. This study was performed to OECD and EU guidelines under GLP conditions and was assigned a Klimisch score of 1.

Justification for selection of genetic toxicity endpoint
No single study can be selected, since all in vitro data are required to address this endpoint (see discussion below).

Short description of key information:
The key study for bacterial gene mutation (Bowles (2003)) was selected on the basis that it is a well reported study conducted to a recognised guideline (OECD Guideline 471) and in line with GLP. The study found no evidence of mutation to S. typhimurium, TA 1535, TA 1537, TA 100, TA 98 or E. coli WP2uvrA, in either the presence or absence of metabolic activation.

The key study examining the cytogenic potential of the test material was Wright & Jenkinson (2004). The study was well reported, conducted to recognised guideline OECD 473 and in line with GLP. Under the conditions of the test, the test material was determined to be non-clastogenic to human lymphocytes. There was no statistically significant increase in the frequency of cell aberrations in the absence or presence of metabolic activation.

The key study looking at the gene mutation potential to mammalian cells of the test substance was Flanders (2012). The study was well reported, conducted to recognised guideline OECD 476 and in line with GLP. The test item did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non-mutagenic under the conditions of the test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In view of the information above, the test substance does not require classification in line with Regulation (EC) No. 1272/2008.