Registration Dossier
Registration Dossier
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EC number: 615-229-7 | CAS number: 70969-57-2
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistency assessment
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.
Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is not readily biodegradable. A degradation rate of 7.6% (CO2 evolution) was determined in a study according to OECD 301B. Thus, the substance is considered to be P and vP.
Bioaccumulation
Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is characterized by a low water solubility (< 1.7E-4 mg/L), high log Kow (> 10) and high molecular weight (1853.05 g/mol). In accordance with the guidance document R.11 (ECHA, 2017) the screening criterion for a potential accumulation in water (log Kow > 4.5) is met. However, further evidence clearly indicates that the substance has a limit potential for bioaccumulation in aquatic organisms.
The uptake of the substance by adsorbtion is considered to be very limited due to sterical hindrance to cross biological membranes. A log Kow of > 10 (15.68 - 48.16) in combination with no toxicity in mammalian toxicity studies are considered as indicators for a limited potential for absorption. A potential for absorption of the substance is further limited by the high molecular weight (1853.05 g/mol). In addition it is clearly stated within the guidance document R.11 that substances with a log Kow > 10 are unlikely to meet the B-criterion.It can be concluded that the bioaccumulation potential of Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] is negligible.
For a detailed reference list please refer to the CSR or IUCLID section 13.
Toxicity
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.
Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is considered to be not toxic. The assessment is based on a chronic toxicity study on Daphnia magna according to OECD 211 determining a NOEC (21 d) of ≥ 100 mg/L. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals. The criteria for “T” based on mammalian effects are therefore not met.
Conclusion
In conclusion, the substance is not PBT/vPvB.
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