Registration Dossier
Registration Dossier
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EC number: 284-957-1 | CAS number: 85005-25-0
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No toxic effects up to the limit of water solubility for Brachydanio rerio (ISO 7346-1); read-across
Key value for chemical safety assessment
Additional information
Since no studies investigating the short-term toxicity to fish of Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with neopentyl glycol (CAS No. 85005-25-0) are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5, a read across to the structurally most similar category member 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) was conducted. Further justification is given within the endpoint summary 6.1 and within the category justification section 13. 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, as it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment by showing a consistent pattern of results.
The key study conducted with 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) was performed, according to the guideline ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish - Part 2: Semi-static method), in a semi-static system, using Brachydanio rerio as test organism (Gode, 2008). The fish were exposed to the nominal test concentrations of 100, 300, 1000, 3000 and 10000 mg/L, for 96 hours. The test solutions were prepared as water accommodated fractions (WAF). No blank control was used in the test. However, as no mortalities were observed at any of the test concentrations, it can be concluded that 2,2- dimethyl-1,3 -propanediyl dioaleate is not acutely toxic to fish at concentrations <= 10000 mg/L. An EC50 of > 10000 mg/L is reported. Taking into account that this test is not regarded as a standard OECD 202, but as a tox limit screening test, a Klimisch grade 2 is justifiable.
Thus, based on theabove mentioned results, and due to the structural and profile similarities of the two substances, as are explained with in the overall endpoint summary 6.1 it can be concluded that no toxicological effects on fish are expected up tothe limit ofwater solubility for Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with neopentyl glycol. As it can be seen in the data matrix of the category justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results, i.e. no toxic effects up to the limit of water solubility.
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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