Registration Dossier
Registration Dossier
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EC number: 286-081-5 | CAS number: 85186-95-4
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the toxicity to terrestrial plants.
Key value for chemical safety assessment
Additional information
No experimental data on toxicity to terrestrial plants are available for NPG esters. According to the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance, where there is no toxicity in the standard acute aquatic toxicity tests, a single soil test on a suitable species would be adequate to meet the requirements of Annex IX (ECHA, 2012). In the case of NPG esters, no toxicity was observed in the acute aquatic studies. The substances are characterised by a high log Koc (> 3), indicating a considerable potential for adsorption to the soil particles. Therefore, tests with soil-dwelling organisms that feed on soil particles are most relevant for the evaluation of soil toxicity of NPG esters. Due to their poor water solubility and high adsorption potential, these substances are not expected to be found in the soil pore water, and uptake by plants is thus very unlikely. As stated in the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance, earthworm testing allows potential uptake vie each of surface contact, soil particle ingestion and pore water, while plant exposure will be largely via pore water (ECHA, 2012). The Guidance also states that in absence of clear indication of selective toxicity, an invertebrate (earthworm or collembolan) is preferred. Therefore, the earthworm was chosen as the most suitable test organism for NPG esters.
A long-term study according to OECD Guideline 222 is available for the NPG ester 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4). 2,2-dimethyl-1,3-propanediyl dioleate has the highest adsorption potential based on Koc. No effects were observed at the test concentration of 1000 mg/kg dw in this study. And due to the structural similarity, other NPG esters are also not expected to have effects on terrestrial macroorganisms.
Furthermore, in a chronic study on Daphnia magna, available for the NPG ester 2,2 -dimethyl-1,3 -propanediyl dioleate (CAS No. 42222 -50 -4), no long-term effects were observed at the test concentration of 1 mg/L, which is far above the water solubility of the NPG esters.
Also, since the substance is readily biodegradable, it is expected to be rapidly eliminated from the terrestrial environment.
Based on the available data, terrestrial toxicity is not of concern for NPG esters.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
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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