Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

long-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
The performance of long-term toxicity to invertebrates is scientifically not justified. REACH Regulation (EC) No 1907/2006, Annex IX, Sect. 9.1.5., Col. 1, requests the performance of a long-term toxicity study on fish with the registered substance. Direct and indirect exposure of the test item to the water compartment is unlikely. NKK-1304 is manufactured and formulated in completely closed systems. Thus, direct and indirect exposure of the water compartment during manufacturing and formulation is practically negligible. Use of formulated NKK-1304 is also unlikely to result in direct and indirect exposure to the water compartment. During use NKK-1304 is included in three-dimensional matrices of resinous material and completely retained, therefore, no direct or indirect release into the water compartment is expected. Any waste water generated during the process (e.g. from cleaning) is collected and disposed of according to national regulations. Based on the production/formulation process and the uses of the registered substance, a study on long-term toxicity to invertebrates is considered scientifically not justified.

Description of key information

According to REGULATION (EC) No 1907/2006 column 2, long-term testing will only be proposed if the chemical safety assessment indicates the need to investigate further effects on aquatic organisms. Based on the information currently available on the substance, the substance is not considered to be a PBT or vPvB. In addition, the chemical safety assessment does not indicate a need for further investigation, therefore a long-term toxicity test to aquatic invertebrates is considered to be not required.

Key value for chemical safety assessment

Additional information