Registration Dossier
Registration Dossier
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EC number: 250-379-3 | CAS number: 30899-62-8
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
NOEC (14 d) ≥ 100 mg/L (from ready biodegradation test, 67.3% biodegradation within 14 days in toxicity control); read-across
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity of Lauric acid ester with hydroxypropanediyl diacetate (CAS 30899-62-8) to activated sludge microorganisms are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Glycerides, C8-21 and C8-21-unsatd. mono- and di-, acetates (CAS 97593-30-1) was conducted.
The target substance is mainly characterized as a triester of glycerol esterified with acetic acid and lauric acid. A structurally very similar substance was selected as source substance. Glycerides, C8-21 and C8-21-unsatd. mono- and di-, acetates (CAS 97593-30-1) is a multi-constituent substance described as a triester of glycerol with acetic acid and lauric acid in a slightly different composition compared to the target 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.
No standard studies evaluating the effects of the source substance Glycerides, C8-21 and C8-21-unsaturated, mono- and di-, acetates (CAS 97593-30-1) on respiration inhibition of activated sludge microorganisms are available. Therefore, a ready biodegradability study is used to derive a NOEC for this endpoint. 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: Endpoint specific guidance, ECHA 2016). 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). For Glycerides, C8-21 and C8-21-unsaturated, mono- and di-, acetates a biodegradation screening test according to OECD 301F is available (Weyers, 2007). This test includes a toxicity control containing 100 mg/L of test material and reference substance (sodium benzoate). Within 14 days, 67.3% biodegradation took place in this toxicity control clearly indicating the lack of toxic potential of Glycerides, C8-21 and C8-21-unsaturated, mono- and di-, acetates to aquatic microorganisms, and therefore, the test item concentration of 100 mg/L can be used as a NOEC (NOEC (14 d) ≥ 100 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 comparable structure and composition, it can be concluded that Lauric acid ester with hydroxypropanediyl diacetate will not inhibit the degradation process in sewage treatment plants.
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