Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

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

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion