Registration Dossier
Registration Dossier
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EC number: 700-213-5 | CAS number: 947753-66-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence Assessment
The subject material was not readily biodegradable when tested in an OECD Guideline 301B test and displayed only 4% degradation after 28 days. There is no additional information on the persistence of the subject material in fresh or estuarine environments or in sediments or soils. Hydrolysis half-life estimates of 206 years (pH 7) or 21 years (pH 8) for the subject material also suggest persistence. Based on the available information, it is is not possible to preclude that the subject material is a P or vP substance.
Bioaccumulation Assessment
There is no bioaccumulation data available for the subject material in an appropriate aquatic species. With a measured (HPLC) log Kow value of 6.32 and an estimated (calculated) BCF factor of 5720, the subject material would be expected to bioaccumulate. However, analysis of the subject material using the OECD QSAR Toolbox (OECD, 2011) indicates a low bioavailability potential based on the Lipinsky Rule of 5 (Lipinski et al., 2001). In the case of the subject material, poor cellular permeability would preclude significant uptake by living organisms. In addition, generalized and active esterases, present in living tissue, would be expected to hydrolyze the subject material, leading to more rapidly eliminated and degraded acid and alcohol components. The subject material is not expected to bioconcentrate under any relevant environmental conditions and thus would not be considered a B or vB substance.
Toxicity Assessment
The subject material showed no significant toxicity in three different aquatic species, representing the three principle trophic levels, when tested at or above maximum achievable water concentrations. Also, there were no reported adverse effects in a chronic (21-day) daphnid study at or above a maximum achievable water concentration. There is also no evidence of significant mammalian toxicity as evidenced by classification as T, R48, or Xn, R48 according to Directive 67/548/EEC; and the subject material is not classified as a CMR material. Based on the available information, the subject material would not be rated as a T substance.
Summary and overall Conclusions on PBT or vPvB Properties
Based on the arguments and information presented above, the subject material would not be rated either as a PBT or vPvB substance.
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