Registration Dossier

Administrative data

long-term toxicity to fish
Data waiving:
other justification
Justification for data waiving:

Data source

Materials and methods

Test material

Constituent 1
Reference substance name:

Results and discussion

Applicant's summary and conclusion

Executive summary:

According to Column 2 of Section 9.1. in the Annex IX of REACH "Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment." Melam is neither classified nor is it a PBT or a vPvB substance. The chemical safety assessment CSA therefore does not need to include a risk assessment and therefore does not "indicate the need to investigate further the effect on aquatic organisms".

Melam has a low acute toxicity to aquatic organisms. There is no relevant difference between the toxicities to aquatic organisms of the 3 trophic levels. Also the long-term studies with Daphnia or algae do not indicate a relevant hazard or the need for classification of melam. It is concluded that the results of further investigations on the toxicity of the substance are not essential for classification or for the chemical safety assessment.

It is concluded that further toxicity tests with fish can be waived.