Registration Dossier
Registration Dossier
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EC number: 287-487-5 | CAS number: 85536-06-7
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
NOEC = 46.9 mg/L (from ready biodegradation test, 81.1% biodegradation in toxicity control within 14 days)
EC50 (18 h) > 0.8 mg/L for Pseudomonas putida (German method)
Key value for chemical safety assessment
Additional information
No experimental data evaluating the effect of Glycerides, C8-18 (CAS No. 85536-06-7) on respiration inhibition of aquatic microorganisms are available. Therefore, data from suitable read-across substances (Glycerides, C8-C10, mono- and di- (CAS No. 85536-07-8) and 1,2,3-propanetriyl trioleate (CAS No. 122-32-7) in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5) are used to cover this endpoint. All three substances are esters formed from the combination of fatty acids and glycerol. The target substance contains fatty acids with C-chain lengths ranging from C8 to C18, and >80% triester content. The two read-across substances cover the fatty acid C-chain range of the target substance, being C8-10 for CAS No. 85536-06-7 and C12-18 (unsaturated) for CAS No. 122-32-7. 1,2,3-propanetriyl trioleate (CAS No. 122-32-7) is predominantly a triglyceride. The triester content of Glycerides, C8-C10, mono- and di- (CAS No. 85536-07-8) is < 15%, containing predominantly mono- and diesters. Due to differences on the degree of esterification of this substance with respect to Glycerides, C8-18 (CAS No. 85536-06-7), a higher bioavailability to aquatic organisms can be expected for the read-across substance (CAS No. 85536-07-8). Generally, a higher degree of esterification will result in an increase of molecular size and weight of the substance. At higher molecular size and weight, the potential to cross biological membranes tends to decrease (Guidance on information requirements and chemical safety assessment, Chapter R.11 (ECHA, 2012). In a publication by Wu et al. (2006), it was demonstrated that free C18 unsaturated fatty acids were consistently more toxic than C18 saturated fatty acids to aquatic organisms. Considering the high content of C18 unsaturated fatty acids of 1,2,3-propanetriyl trioleate (CAS No. 122-32-7) and the expected higher bioavailability of the other read-across substance, they represent a worst-case scenario for Glycerides, C8-18 (CAS No. 85536-06-7).
If a compound degrades well in a ready biodegradability 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, ECHA 2012). A substance can be assumed to be not inhibitory of the activity of aquatic microorganisms if, in the toxicity control of a ready biodegradation test, more than 25% biodegradation occurs within a period of 14 days (OECD Guideline 301). A ready biodegradation test is available for Glycerides, C8-C10, mono- and di- (CAS No. 85536-07-8). In this test (Flach, 2012) a toxicity control is included, containing 46.9 mg/L of test material. Within 14 days, 81.1% biodegradation took place in this toxicity control clearly indicating the lack of toxic potential of the test item to activated sludge microorganisms, and therefore, the test item concentration of 41.1 mg/L can be used as a NOEC value.
Additionally, a study conducted with Pseudomonas putida is available for the category member1,2,3-propanetriyl trioleate (CAS No. 122-32-7). This test was performed according to the German method “Assessment of hazardous substances in water, Determination of the acute toxicity in Bacteria”, under GLP conditions. Pseudomonas putida cultures were exposed to the test substance for 18 hours in a static water regime at 25°C and effects on cell proliferation were assessed (as the extinction of the monochromatic radiation at 436 nm in a 10 mm layer). After the exposure period, no inhibitory effects on cell multiplication could be observed up to the highest concentration tested and therefore, the EC50 (18 h) was determined to be > 0.8 mg/L (nominal concentration).
Based on the above information, it is considered that Glycerides, C8-C18 is not inhibitory of aquatic microorganisms activity and further testing for this endpoint is not deemed necessary.
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