Registration Dossier
Registration Dossier
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EC number: 290-260-3 | CAS number: 90106-38-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Rosa damascena, Rosaceae.
Endpoint summary
Administrative data
Description of key information
Based on experimental studies on the registered substance performed in compliance with GLP statements, the key ecotoxicity values of the substance are as follow:
- Aquatic Invertebrates: 48-h EC50 was 29.1 mg test material/L, based on nominal concentration (lowest acute E(L)C50)
- Aquatic algae: 72-h ErC50 was 175.0 mg test material/L based on growth rate (nominal)
Based on these results, the lowest acute E(L)C50 is higher than 1 mg/L.
Therefore, the substance would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.
Additional information
Short-term toxicity to fish was not provided in the dataset since the tonnage band (1 -10 tonnes/year) does not require that endpoint.
Acute toxicity to aquatic invertebrates (Daphnia magna) and to algae have been determined in experimental studies performed under GLP compliance in accordance with OECD 202 and OECD 201 guidelines respectively. The studies were considered as valid. They were acceptable for these ecotoxicological endpoints.
CLP Classification proposal
It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).
Acute aquatic hazard: not classified. Reasoning: lowest E(L)C50 higher than 1 mg/L.
Chronic aquatic hazard: category 3. Reasoning: sufficient chronic toxicity data are not available, lowest acute E(L)C50 value is between 10 and 100 mg/L (aquatic invertebrate: 29.1 mg/L), the substance is rapidly degradable but has at least a constituent with a log kow > 4 (based on the SIP).
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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