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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:

The PBT Assessment for acetalization product beween glucose and 12-hydroxystearyl alcohol is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2008).

The substance is readily biodegradable according to OECD 301 F (67.3% O2 consumption after 28d). Thus the substance does not meet the criteria for persistence and is not considered to be persistent or very persistent.

The substance has a log Kow of 7.7. Based on a weight of evidence strategy taking into account uptake data and chronic toxicity data performed on structurally similar substances, the test item seems to have a limited dermal penetration potential and no sign of toxicity after repeated exposure.

The substance is not classified as CMR according to directive 67/548/EEC and regulation EC 1272/2008 and no evidence of toxicity was highlighted in available chronic tests of substances in the same category.

No aquatic chronic data on the substance is available but available aquatic acute data show no toxicity to the aquatic compartment (EC50 and LC50 > 100 mg/l)