Registration Dossier
Registration Dossier
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EC number: 200-875-0 | CAS number: 75-50-3
Endpoint summary
Administrative data
Description of key information
Additional information
According to Regulation (EC) No 1907/2006, Annex IX (section 9.4) terrestrial toxicity studies do not need to be conducted if direct or indirect exposure to soil is unlikely. Furthermore, according to Regulation (EC) No 1907/2006 Annex XI sections 3.1 and 3.2(b) (as amended by Regulation 134/2009) testing in accordance with Annex IX (incl. section 9.4, Effects on terrestrial organisms) may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (CSR), when the substance is not incorporated in an article and the manufacturer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4) (a) to (f) Regulation (EC) No 1907/2006 apply.
On the basis of the present process conditions, as described in the attached waiving-justification document ‘75-50-3_Exposure Based Waiving for Trimethylamine_2018-08-17', the criteria of exposure-based adaptation of information requirements are met due to the lack of direct or indirect exposure to soil.
In addition, the hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment.
Furthermore, the risk assessment results in Risk Characterisation Ratios far below 1 for the terrestrial compartment.
Therefore, testing of Trimethylamine (TMA) CAS No. 75-50-3 in terrestrial toxicity studies was not performed.
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