Registration Dossier
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EC number: 269-023-3 | CAS number: 68171-33-5
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
EC50 > 100 mg/L for activated sludge (OECD 209)
Key value for chemical safety assessment
Additional information
There are no studies available on the microorganism toxicity of isopropyl isostearate (CAS No. 68171-33-5). The assessment was therefore based on studies conducted with the structurally most similar category members, isopropyl oleate (CAS No. 112-11-8) and isopropyl myristate (CAS No. 110-27-0) as part of a read across approach. This is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Further justification is given within the endpoint summary 6.1 and within the category justification section 13. In this case of read-across, the best suited (highest degree of similarity, nearest physico-chemical properties) read-across substances were entered into IUCLID. Nevertheless, as can be seen in the data matrix of the category justification in Section 13, all reliable data in the category support the hazard assessment for this endpoint, by showing a consistent pattern of results.
The key study with isopropyl oleate (CAS No. 112-11-8) was performed as a limit test according to the guideline ISO 10712 (Mead, 1997). A culture of the test organism Pseudomonas putida was exposed to the test substance in a static system for 16 hours, at the nominal concentration of 10000 mg/L. There was no significant difference in growth rate between the control and the 10000 mg/L loading rate. A nominal EC50 > 10,000 mg/L is reported.
The supporting study with isopropyl myristate (CAS No. 110-27-0) was performed according to a national guideline similar to DIN 38412, part 8 and GLP (Coenen, 1988). A culture of the test organism Pseudomonas putida was exposed to the test substance in a static system for 18 hours, at the nominal test concentrations 0, 0.004, 0.008, 0.016, 0.031, 0.063, 0.125, 0.25, 0.5, 1, 2, 4, 8, 16 mg/L. Since all the measured extinction values were very close to the reference, no real toxicity threshold could be determined. It can, however, be concluded that the substance has no effect on the growth of P. putida up to the concentration of 16 mg/L.
Thus, based on theabove mentioned results, and due to the structural and profile similarities of the substances, as are explained within the overall endpoint summary 6.1 it can be concluded that no toxicological effects on microorganisms are expected up tothe limit ofwater solubility for isopropyl isostearate (CAS No. 68171-33-5).
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