Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

short-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
[Specific explanation in addition to field 'Justification for data waiving']

Higher Tier Study available:

Instead of the daphnia magna test a higher tier study, the short term toxicity study on fish was already available. The registrant made a new study on algae. The combination of both and the test of biodegradability lead to a classification as aquatic chronic 2 and H411. The test on algae showed, that the substance is not stable under the conditions of the test. This was taken into account by using the geometric mean value of the concentration for the calculation of the effect level. This is a rather conservative approach. QSAR calculations with the OECD Toolbox predict much less toxicity for daphnia, than the one taken into account for the classification.

Exposure based waiving:

The substance is used completely as an onsite intermediate, there are no other registrants in the EU, therefore there is no other use for the substance.
Waste water, which is generated in the synthesis is not released to the river, but is for several reasons completely incinerated externally. Therefore no emission into the water compartement must be considered.

Considering all arguments, an additional test on invertebrates is unnessecary and disproportionate and will have no additional benefit for the environment.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion