Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing to aquatic organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous or is assessed to be a PBT or vPvB. The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. For the aquatic compartment, acute toxicity studies on alga, daphnia and fish as well as microorganism showed no effect up to the water solubility of the substance. These data can be used for the CSA and as result of the assessment, no further information is required. Therefore, and for reasons of animal welfare, a chronic test on vertebrates is not provided.