Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

For this endpoint, the read across between PWH/ammonium and PWH/sodium salt is valid, because this toxicological property is defined by the main component.The read across justification that takes into account the ammonium ion properties is attached on section 13 of the dossier.

The substance Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified did not induce reverse mutation in Salmonella typhimurium or Escherichia coli (Bisini, 2012) , not induce mutation at the TK locus of L5178Y mouse lymphoma cells

(Salvador, 2012) and not induce chromosomal aberrations in Chinese hamster ovary cells (Ciliutti, 2012).

Based on results it is concluded that the substance is not genotoxic with or without metabolic activation and no further investigations are required.


Justification for selection of genetic toxicity endpoint
GLP compliant , OECD and EU guidelines, well described

Short description of key information:
No genotoxic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.

For the purpose of classification for germ cell mutagenicity, substances are classified if there is at least positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:

— somatic cell mutagenicity tests in vivo, in mammals; or

— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

All the presented results from in vivo tests are negative, therefore it is concluded that PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO, SULFOCHLORINATED SAPONIFIED (C14-C17) is not genotoxic with or without metabolic activation.