Registration Dossier
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EC number: 284-864-6 | CAS number: 84988-75-0
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
Description of key information
The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114546485-42-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
The current hazard assessment is based on the data presently available.
Key value for chemical safety assessment
Additional information
The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114546485-42-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
The current hazard assessment is based on the data presently available.
Since no studies investigating the toxicity to terrestrial plants of fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (CAS 84988-75-0) are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related category member butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. Nevertheless, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results. The study was performed according to OECD 208 with two dicotyledon (Raphanus sativus & Glycine max) and one monocotyledon species (Avena sativa). Five different concentrations up to 1000 mg/kg soil were tested and the effect parameters germination, phytotoxicity, growth stages, mortality and fresh weight were measured. The most sensitive species based on fresh weight was Avena sativa with an EC50 of 263.79 mg/kg soil, followed by Raphanus sativus and Glycine max with an EC50 of 526.47 and 2978.54 mg/kg soil, respectively. Moreover, the test substance caused a statistically significant reduction in germination of Raphanus sativus (from 444 mg/kg soil onwards) but did not affect germination rate of Avena sativa and Glycine max. Phytotoxic effects appeared as reduction of growth stages of Raphanus sativus and Avena sativa. No mortality occurred in soil treated with the test substance. All tested species showed the same effects, which are not typical phytotoxic effects as known for plant protection products (e.g. chlorosis and necrosis). The effects are resembled more growth depression like caused by a permanent water deficiency from the beginning of germination. Observed effects might have been caused by obstruction of water uptake through the roots. Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by an equal ecotoxicological profile, it can be concluded that the effects of fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol will be in the same range.
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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