Registration Dossier

Diss Factsheets

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 o 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 that it is neither a PBT or vPvB substance. The substance has to be classified as dangerous to the environment, but for the aquatic compartment acute studies with fish and daphnia on several DMAs give evidence that fish is clearly less sensitive that aquatic invertebrates. A long term studies on daphnia magna with C12-14-DMA and C16-18-DMA (see 6.1.4) were carried out. These data can be used for the CSA and as result of the assessment, no further information is required. Consequently, there is no need for an additional study using vertebrates.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Categories Display