Registration Dossier

Administrative data

Endpoint:
long-term toxicity to fish
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Based upon these QSAR assessments, the water solubility of this UCVB material has been estimated to be 6.5E-8 mg/L, which is considered to be below the detection limit of typical ‘cold’ analytical methods. The substance is concluded to be highly insoluble in water.
On the basis that the substance is so insoluble in water that it would be practically impossible to prepare a suitable solution in test media or develop a suitable analytical method to detect the substance in test media, the data for acute toxicity to fish, acute toxicity to Daphnia and algal growth inhibition have been completed using a Water Accommodated Fraction intended to maximise the possibly bioavailable fraction of the UVCB to the test organisms. These studies have been completed as limit tests.
Annex XI of REACH lays out the rules for adaptation of the standard testing methods. In particular, Section 2 of Annex XI acknowledges that in some cases, testing for certain endpoints may not be technically possible due to the physical properties of a substance, which include solubility in water.
In accordance with Annex XI, Section 2, the chronic toxicity to fish and Daphnia are waived due to the extremely low water solubility of the substance, which would make it impossible to prepare meaningful dosing solutions. Due to the extremely low water solubility, chronic toxicity testing for fish and Daphnia are technically not feasible.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
The study is considered not scientifically justified.
Executive summary:

The data available from the acute toxicity to fish study endpoints conducted as WAFs suggests that the LC50 is well in excess of the water solubility and gave rise to no concern with regard to the toxicity of the substance to fish in the aqueous environment. Furthermore, adequate controls are in place during production and use of the substance to ensure that the substance is not released to the aqueous environment.

In view of this and considering the best interests of animal welfare, it is therefore considered not scientifically justified to conduct further data on this species.