Renewable hydrocarbons (naphtha type fraction)

Toxicity to reproduction

Administrative data

Endpoint:

two-generation reproductive toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented

Justification for type of information:

Based on Annex XI, section 3 of REACH, no study was conducted since there is enough evidence on reproduction toxicity of the identified ingredients of the substance. Currently this UVCB substance is in pilot production phase and no representative sample is available. Thus, also for animal welfare reasons, no long-term toxicological studies have been conducted for the substance at this stage of the CSA. This substance contains n-hexane (< 5 %) and toluene (< 5 %). n-Hexane is classified toxic to fertility with harmonized C&L entry of Repr. 2 H361f and toluene to cause development toxicity with harmonized C&L entry of Repr. 2 H361d. The generic limit value of individual substance in CLP regulation which triggers the classification of mixtures to toxic for reproduction (Repr. 2) is ≥ 3 %. Thus, classification is warranted to the substance based on CLP mixture rules. The CSA indicates that no further investigations on reproduction effects are necessary. In addition, for animal welfare reasons no testing proposal is prepared. The classification to reproduction is warranted based on the maximum concentrations of the most critical constituents (toluene and n-hexane) in the substance

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:

not specified