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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
toxicity to terrestrial arthropods
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Materials and methods

Test material

Constituent 1
Reference substance name:
melam
IUPAC Name:
melam

Results and discussion

Applicant's summary and conclusion

Executive summary:

# Annexes VII and VIII of REACH do not require investigations with terrestrial invertebrates. According to Section 9.4. of Annexes IX and X of REACH, investigations with terrestrial invertebrates are required (under certain conditions) but not specifically with arthropods. A study with an invertebrate species is already reported in Section 6.3.1.

# According to Column 2 of Section 9.4. in the Annex X of REACH "Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome 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 effects of the substance and/or degradation products on terrestrial organisms." It is concluded that the results of further investigations on the toxicity of melam are not essential for classification or for the chemical safety assessment.

# According to Column 2 of Section 9.4. in the Annex X of REACH "These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely." A direct exposure of soil is not intended and an indirect exposure to soil is unlikely, as the only use of melam is, to be included into a plastic matrix.

It is concluded that tests with arthropods can be waived.