Registration Dossier
Registration Dossier
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EC number: 253-575-7 | CAS number: 37640-57-6
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Administrative data
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Additional information
In accordance with Regulation (EC) No 1907/2006, Annex IX 9.4, column 2 studies investigating the effects on terrestrial organisms do not need to be conducted if direct and indirect exposure to the soil compartment is unlikely.
The test item has a low potential to adsorb to soil. The log Pow is estimated to be in the range of -2.
Melamine (CAS 108-78-1) has a low potential to absorb to soil. The log Pow is in the range of -1 and the log Koc is estimated to be in the range of 1. Based on both parttition coefficients the adsoprtion to soil or sediment is expectd to be low. Therefore, an expostition of soil or sediment living organsims is low.
Cyanuric acid (CAS 108-80-5) has a low potential to absorb to soil. The log Pow is in the range of 2 and the log Koc is estimated to be in the range of 0 to 2. Based on both parttition coefficients the adsoprtion to soil or sediment is expectd to be low. Therefore, an expostition of soil or sediment living organsims is low.
REACH criterion: "In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms."
Guidance Document R.7.c.: The PNECsoil can be estimated by the equilibrium partitioning method from the PNECaquatic, especially in case the substance is not strongly adsorptive, as is melamine. This method is used to estimate the PNEC.
Melamine has a low toxicity to mammals and aquatic organisms, not leading to a classification.
The chemical safety assessment therefore does not include a risk assessment and therefore do not indicate the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms.
Guidance Document R.7.c.: "The absence of chronic or long-term effects in aquatic organisms up to the substance solubility limit, or of acute effects within the solubility range above 10 mg/l (melamine meets both criteria) can be used to waive the data requirements of Annex IX and X."
The supporting studies, 2 on plant toxicity (Jansen 1982, Koch 1986) and 1 on soil nitrifying microorganisms (Hauck 1964) indicate a low toxicity of melamine.
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