Registration Dossier
Registration Dossier
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EC number: 306-083-2 | CAS number: 95912-87-1
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
NOEC (3 h) of ≥ 1000 mg/L for activated sludge microorganisms (OECD 209).
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity to microorganisms of fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) 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 dodecyl oleate (CAS 36078-10-1) was conducted. The read-across substance is characterized by a fatty acid of C18 unsatd. and an alcohol component of C12. The target substance is characterized by a fatty acid of C16-18 and an alcohol component of C12-C18 which is very similar to the composition of the read-across substance.
This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the category 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. 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 of each category member by showing a consistent pattern of results.
The study with the read-across substance dodecyl oleate was performed according to OECD 209 under GLP conditions (Brunswik-Titze, 2012). A limit test with a concentration of 1000 mg/L did not result in inhibition of respiration rate of activated sludge microorganisms (obtained from a sewage treatment plant treating predominantly domestic wastewater). An increase of respiration was observed in all three test vessels. Thus, a NOEC (3 h) of ≥ 1000 mg/L was derived.
An additional study with fatty acids, C16-18, C12-18-alkyl esters itself was rated reliability 3 since it was not conducted according to today’s standard methods (Wierich, 1999). The O2 consumption of Pseudomonas putida was measured for 30 min with a concentration of 10000 mg/L (nominal). No inhibition of respiration was observed resulting in an EC10 (3 h) > 10000 mg/L. However, the result supports the outcome with the read-across substance.
Based on the available result from one structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure and a supporting study with P. putida, it can be concluded that fatty acids, C16-18, C12-18-alkyl esters will not exhibit effects on aquatic microorganisms.
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