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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

The substance was inherently biodegradable in a study similar to OECD Guideline 302 B. By analogy toC8-18 and C18 unsatd. AAPB the substance is regarded as readily biodegradable and thus, isnot 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 3.54 (≤ 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, C12-18 AAPB can be considered to be not B and not vB.

 

Toxicity

Measured long-term ecotoxicity data are not available for C12-18 AAPB. Still, an analogy can be made with C8-18 AAPB for which such data are available and showed to be 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, C12-18 AAPB can be considered to be not T.

 

Conclusion

Based on available data, C12-18 AAPB is 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 by analogy with C8-18 AAPB; not classified as carcinogenic, mutagenic or toxic for reproduction). Consequently, C12-18 AAPB does not meet the PBT or vP/vB criteria according to Annex XIII of the REACH Regulation.