Registration Dossier

Administrative data

bioaccumulation in aquatic species: fish
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:

In the R7 guidance, commenting the column 2 of Annex IX of REACH, it is state that a study is not necessary if direct and indirect exposure of the aquatic compartment is unlikely (implying a low probability of – rather than low extent of – exposure). At the manufacture stage strict risk management measures are taken to avoid water exposure. During the formulation stage there is no release to water as all fluids, used for cleaning equipment, are sent to external waste treatment. For the consumer use (“dye for ink for ballpoint and cartridge) the exposure to waste water is probably overestimated by using the generic environmental release factor ER11a and is still very low.
However, the probability of exposure is not completely absent, and dietary bioaccumulation test (that is practically much easier to conduct for poorly water-soluble substances than the OECD 305 guideline) may be proposed. The realization of the test was pending to the results of the long-term studies.
Based on the results of the OECD 211 Daphnia magna Reproduction test, Semi-static, 21 days the substance is now T in addition to being P/vP. The outcome of the OECD 210 Fish, Early-Life Stage (FELS), which covers several life stages of the fish from the newly fertilised egg, through hatch to early stages of growth, does not allow to conclude with sufficient confidence on the B criterion: at the highest tested doses (0.1 and 0.25 mg/L) all the larvae died within 2 days after hatching. However, at the 3 other testing doses, no effects were observed until 30 days post-hatching up to 40 µg/L.

Therefore, the bioaccumulation potential of the substance needs to be assessed according to the ITS provided by the guidance documents:
• No literature data was found on the substance nor on any analogues,
• An attempt to better estimate the Log Kow of the substance will be made,
• The support of an ecotoxicologist expert is seeked,
• Several non-commercial Q(S)AR models were used, indicating a BCF < 2000, but the substance was not failing in the applicability domain of the models: other commercial models are still available for the prediction of the BCF, like CATALOGIC v5.11.1 (BCF base-line model v01.04), however a license must be bought. Before bying any license, the applicability domain must be evaluated,
• Exchanges with the laboratory for the feasibility of the in vitro study.

If finally, no conclusions can be made, an experimental study plan will have to be submitted.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion