Registration Dossier
Registration Dossier
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EC number: 931-296-8 | CAS number: 97862-59-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence
The substance proved to be readily biodegradable in studies conducted according to OECD Guideline 301 B and EU Method C.4-E and thus, is not P and not vP.
Bioaccumulation
Measured BCFs are not available. Still, these derivates fall in the range of applicability of a scientifically valid (Q)SAR model: BCFWIN. Therefore, BCFWIN v2.15 was used to calculate the BCF values for the C8-C18 derivates of AAPB. The calculation yielded values in the range between 3 (C8 fatty acid derivate) and 71 (C10 – C18 and C18 unsaturated fatty acid derivates). Based on these calculated BCFs, a low potential for bioaccumulation is to be expected for AAPBs. This conclusion especially applies to C12 AAPB and is further supported by a log Kow value of 4.2 (≤ 4.5) estimated using the chemical properties prediction software ACD/Labs v12 and the experimentally determined Koc of C12 AAPB. Based on these (Q)SAR results, C8-18 AAPB can be considered to be not B and not vB.
Toxicity
Long-term ecotoxicity data were in the range between 0.135 mg/L (Oncorhynchus mykiss: 28-day NOEC) and 0.300 mg/L (Daphnia magna: 21-day NOEC), well above 0.01 mg/L. Besides, the substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008. Moreover, there is no evidence that the substance exhibits chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008. Based on these results, C8-18 AAPB can be considered to be not T.
Conclusion
Based on available data,C8-18 AAPBis not P/vP (readily biodegradable), B/vB (calculated BCF < 2000; estimated log Kow ≤ 4.5) and not T (NOEC ≥ 0.01 mg/L for marine/freshwater organisms; not classified as carcinogenic, mutagenic or toxic for reproduction). Consequently, C8-18 AAPB does not meet the PBT or vP/vB criteria according to Annex XIII of the REACH Regulation.
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