Registration Dossier
Registration Dossier
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EC number: 224-160-8 | CAS number: 4219-49-2
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
No effects to microorganisms were observed in the available studies.
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity to microorganisms of 2-hydroxyethyl palmitate (CAS 4219-49-2) are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the two structurally most similar category members propylene glycol diisostearate (CAS 68958-54-3) and butylene glycol dicaprylate/dicaprate (CAS 853947-59-8) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 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 first study with propylene glycol diisostearate was performed according to ISO 10712 under GLP conditions with Pseudomonas putida (Mead, 1997). A filtered test substance concentration of nominal 10000 mg/L was tested in this study. No inhibition of growth was observed after an incubation of 16 h resulting in an EC10 of > 10000 mg/L (nominal). The influence of the read-across substance butylene glycol dicaprylate/dicaprate to activated sludge microorganisms was investigated in a GLP study according to EU Method C.11 (Diefenbach, 1997). A test concentration of nominal 1099 mg/L did not result in an inhibition of the respiration rate after 3 h. Thus, an EC10 of > 1099 mg/L was derived.
One additional study is available for the target substance fatty acids, C16-18, esters with ethylene glycol itself (Diefenbach, 1995). However, this study was rated as “not reliable” since it does not meet important criteria of today’s standard methods. It was not performed according to an internationally accepted guideline. The respiration rate of Pseudomonas putida was measured for 4.75 h. No effects were observed and an EC50 (4.75 h) > 0.99 g/L was derived.
Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by an equal ecotoxicological profile, it can be concluded that 2-hydroxyethyl palmitate will not exhibit effects on the respiration rate of microorganisms.
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