Registration Dossier
Registration Dossier
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EC number: 619-682-1 | CAS number: 224049-04-1
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
In accordance with Regulation (EC) No 1907/2006, Column 2 of Annex IX and X, section 9.4 toxicity tests on terrestrial organisms do not need to be investigated if the outcome of the chemical safety assessment shows no indication of risk on terrestrial organisms from exposure to the substance in question. In a first step, the soil PNEC for Isotianil has been derived using a PNEC derived from the most sensitive terrestrial studies, i.e. two soil microorganism studies (carbon and nitrogen transformation tests). The risk characterization ratio (RCR) has demonstrated that there is no indication of risk i.e. PEC/PNEC soil < 1 from current exposure conditions to Isotianil.
Furthermore, extensive simulation tests on biodegradation in water/sediment systems as well as in soil under aerobic and anaerobic conditions explicitly demonstrated a rapid degradation of Isotianil and its degradation/transformation products, respectively. Thus, Isotianil has potential for accumulation and will not persist in the environment. In addition extensive carbon and nitrogen transformation tests investigating the toxicity of Isotianil to soil microorganisms clearly resulted in no adverse effects to the soil microflora.
In conclusion, in accordance to Regulation (EC) No. 1907/2006, Annex IX and X, Column 2, 9. 4 and based on the explanations given here, no further effects of Isotianil on terrestrial organisms need to be investigated and tests are therefore not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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