Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
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 highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Column 2 of Annex VII of REACH Regulation states an adaptation from column 1: there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water.

According to the ECHA guidance (Chapter R.7b: Endpoint specific guidance, 2017) a short-term toxicity testing on invertebrates (preferably Daphnia) does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur e.g. the substance is highly insoluble in water or the substance is unlikely to cross biological membranes).

According to the available data (Company experimental internal data, estimated data and data collected from scientific literature) the water solubility of the substance ranges from
(i) <1 mg/L (determined by Flask Method (according to Regulation N. 440/2008), it means that it has a value of detection below the limit of quantification of the method.
(ii) 2.132e-005 mg/L (estimated by EPI SuiteTM v4.11, model used: WSKOW v1.42).
Moreover, in the relevant scientific literature the substance is recognized as insoluble in water.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion