Registration Dossier
Registration Dossier
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EC number: 233-864-4 | CAS number: 10401-55-5
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
NOEC (3 h) of ≥ 1000 mg/L (OECD 209)
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity of hexadecyl (R)-12-hydroxyoleate (CAS 10401-55-5) to activated sludge microorganisms are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related source substance dodecyl oleate (CAS 36078-10-1) was conducted. The read-across substance is representative to evaluate the toxicity of the target substance hexadecyl (R)-12-hydroxyoleate to activated sludge microorganisms. Based on the specification the target substance hexadecyl (R)-12-hydroxyoleate is mainly specified as an ester of a linear C16 alcohol and a C18:1(OH) fatty acid. The source substance is characterized by a similar alcohol (C12) and fatty acid component (C18:1). The smaller alcohol chain length increases the water solubility and therefore the bioavailability in the test medium since the water solubility is dependent on the C-chain length (Lide, 2005). However, the water solubility of all substances is very low (<0.7 mg/L at 24 °C for the target substance and < 0.05 mg/L at 20 °C for the source substance). This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID 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.
The available study was performed according to OECD 209 (GLP) using activated sludge from a predominantly domestic sewage treatment plant (Brunswik-Titze, 2012). A limit test with a nominal concentration of 1000 mg/L was performed for 3 h. The respiration rate of activated sludge microorganisms was not inhibited resulting in a NOEC (3 h) of ≥ 1000 mg/L.
Based on the available result from one structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that hexadecyl (R)-12-hydroxyoleate will not exhibit effects on activated sludge microorganisms. The inhibition of the degradation process in sewage treatment plants is not anticipated.
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