Registration Dossier

Administrative data

Endpoint:
toxicity to soil microorganisms
Data waiving:
study scientifically not necessary / other information available
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:

# Melam has a low solubility in water and no relevant bioaccumulation potential.

Melam has no toxic effects up to high (limit) concentrations to aquatic microorganisms (see section 6.1.7.) as well as to soil macroorganisms (6.3.1.) and to terrestrial plants (6.1.6.):

- Aquatic microorganisms: The EC50 of the test substance on activated sludge respiration is above 100 mg/L.

- Earthworm: The 7d LC50 and 14d LC50 of the test substance are higher than 100 mg/kg.

- Plants: LC50 (for seedling emergence), EC50 (for growth) and LOEC values are all above 100 mg/kg, NOEC values are all 100 mg/kg.

It can therefore be expected that also the possible acute toxicity of melam to soil microorganisms will be low.

# According to Column 2 of Section 9.4. in the Annex IX of REACH "In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms". This can be applied as toxicity data for aquatic organisms are available. A PNECsoil could be calculated from the PNECwater using Equilibrium Partitioning.

# And further in Column 2: "The choice of the appropriate tests 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 no "appropriate tests" have to be chosen.

Further tests:

# 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."

# 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 the results of further investigations on the toxicity of melam are not essential for classification or for the chemical safety assessment. A toxicity test with soil microorganisms can be waived.