Registration Dossier
Registration Dossier
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EC number: 615-229-7 | CAS number: 70969-57-2
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to microorganisms, other
- Remarks:
- toxicity control of ready biodegradability study
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification document provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Result of toxicity control from ready biodegradability test
- Remarks on result:
- other:
- Remarks:
- source, RA-A, CAS 68604-38-6, REAGENS, 2012, Toxicity Control of OECD 301 B, RL2
Reference
Description of key information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
Key value for chemical safety assessment
Additional information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
No study investigating the toxicity of Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2- (hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) to aquatic microorganisms is available. Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) is applied.
Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substance, the source substance is considered a suitable representative for the evaluation of the toxicity of the target substance to aquatic microorganisms. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.
Since no studies on the toxicity to activated sludge microorganisms are available a toxicity control from a ready biodegradability study of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) is used to derive a NOEC for the toxicity to activated sludge microorganisms. 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 2017).
A substance can be assumed to be not inhibitory to activated sludge microorganisms, if in the toxicity control of a ready biodegradation test, more than 25% degradation based on CO2 evolution (CO2/ThCO2) occurred within 14 days (OECD guideline 301). For Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) a biodegradation test according to OECD guideline 301B is available. The test includes a toxicity control, which contains 20 mg/L of the test substance and 20 mg/L of the reference material (sodium benzoate). The toxicity control attained 26.7% degradation after 5 days of incubation (40.9% after 14 d). Hence, the substance is not toxic to aquatic microorganisms in the toxicity control and a NOEC (14 d) ≥ 20 mg/L was derived.
Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2- (hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) will not exhibit effects to microorganisms up to the limit of water solubility.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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