Registration Dossier
Registration Dossier
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EC number: 604-608-2 | CAS number: 147853-32-5
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
NOELR (16h) >= 1000 mg/L (Pseudomonas putida, ISO 10712), RA
NOEC (28d) = 12.4 mg/L (toxicity control of ready biodegradation test according to OECD 301 B)
Key value for chemical safety assessment
Additional information
No studies investigating the toxicity to microorganisms of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated (CAS 147853-32-5) are available. Therefore, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5, a read-across to the structurally similar substance Fatty acids, C18-unsatd., dimers (CAS 61788-89-4) was conducted. Further justification is given in the overall endpoint summary (IUCLID Chapter 6.1) and within the analogue justification attached in IUCLID Section 13.
The key study conducted with Fatty acids, C18-unsatd., dimers (CAS 61788-89-4) was performed as a limit test following a guideline similar to ISO 10712 and according to GLP (Sewell, 1997). The test organism Pseudomonas putida was exposed to the test substance at a loading rate of 10000 mg/L, prepared as water accommodated fraction (WAF), for 16 hours. As no significant growth inhibition was observed, the NOELR was reported to be ≥ 10000 mg/L.
A suppporting GLP study includes an assessment of the toxicity of Fatty acids, C18-unsatd., dimers (CAS 61788-89-4) on cell multiplication of a pure culture of Pseudomonas putida (Coenen, 1988). No guideline was mentioned. After 18 h no effect on the growth inhibition of Pseudomonas putida was observed, and an EC50 > 4.8 mg/L (nominal, highest concentration tested) was stated.
Besides, the toxicity control of the available ready biodegradation study (OECD 301B) can be used to derive a NOEC for the toxicity to aquatic microorganisms (Clarke, 2004). If a compound degrades well in a ready biodegradation test, or does not inhibit the degradation of a positive control at a certain concentration, this concentration can be used as a NOEC value. This approach is in accordance with the Guidance on information requirements and chemical safety assessment (Chapter R.7b: Endpoint specific guidance, ECHA 2012). A substance can be assumed to be not inhibitory to aquatic microorganisms, if in the toxicity control of a ready biodegradation test more than 25% degradation based on CO2 evolution (ThCO2) occurred within 14 days (OECD 301). The available study includes a toxicity control which contains 12.4 mg/L of the substance and 17.1 mg/L of the reference material sodium benzoate. The toxicity control attained 26% degradation after 14 days of incubation. Hence, the substance is not toxic to aquatic microorganisms in the toxicity control and the test item concentration of 12.4 mg/L could be used as NOEC.
Based on the above mentioned results and the substance similarities in structure and profile as explained within the overall endpoint summary (IUCLID Chapter 6.1), toxicity of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated (CAS 147853-32-5) to microorganisms is not expected.
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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