Registration Dossier

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.