Registration Dossier
Registration Dossier
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EC number: 251-846-4 | CAS number: 34140-91-5
Endpoint summary
Administrative data
Description of key information
A terrestrial PNEC = 11,1 mg/kg dw soil is calculated from long term toxicity tests on three species (earthworms, plants and micro-organisms) therefore a security factor of 10 is applied. Terrestrial plants are the most sensitive species (NOEC = 111,1 mg/kg dw).
Additional information
For terrestrial organisms, three long term studies were conducted (after their agreement upon Testing Proposals) on the registered substance.
A long term study (reproduction) is available on the registered substance (N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate, CAS 34140-91-5) towards Eisenia fetida. In this 8 -week test (reliability 1) according OECD guideline 222 and GLP the overall NOEC for reproduction, mortality and biomass was found to be = 1000 mg test item/kg soil (dry weight).
Additionnaly, a test according to the OECD TG 208 and GLP on six species of terrestrial plants was conducted. Based on growth effects (fresh and dry weight observed on Mustard and Cucumber) the NOEC is considered to be equal to 111.1 mg test item/kg soil dry weight.
A toxicity test on soil micro-organisms according to the OECD TG 216 and GLP was conducted. The test item showed no significant adverse effect on the nitrogen activity of soil microorganisms up to the highest tested concentration over a 28-day period. The NOEC is therefore considered to be equal to or greater than 1000.0 mg test item/kg soil dry weight.
It is laid down in the REACh Regulation EC 1907/2006 Annexes IX and X, section 9.4., column 2, that terrestrial toxicity testing shall be proposed by the registrant if the chemical safety assessment (CSA) indicates such a need. No relevant information is available on the toxicity of the registered substance to soil microorganisms and plants. Therefore, a “soil hazard category” was assigned to the registered substance, following the rules set on page 158 of the guidance. The substance is very toxic to aquatic organisms and is highly sorptive. It falls therefore within the scheme of “Hazard category 4”, which states the EPM method is not applicable and that toxicity must be investigated for the three trophic levels.
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