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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11-C14 aliphatics, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and undecan-1-ol. As defined in the ‘Read-Across Justification Document’ in section 13 of the IUCLID file, data provided for these constituents when considered together is representative of Alchisor TAL 123 and suitable for assessment purposes. Alchisor TAL 123 constituents do not fulfil the criteria for persistence, bioaccumulation or toxicity. The overall conclusion is that constituents of Alchisor TAL 123, and therefore, Alchisor TAL 123, do not meet the PBT or vPvB criteria. No further testing is required.

PBT Assessment

Persistence: From a comparison of the results obtained for Alchisor TAL 123 and constituents (namely Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and undecan-1-ol) with the criteria of REACH Annex XIII, it can be concluded that Alchisor TAL 123 is not persistent (P) under aerobic conditions.

Bioaccumulation: The constituents (namely Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and undecan-1-ol) cannot be regarded as bioaccumulative in aquatic, sediment or terrestrial organisms. The data requirement for bioaccumulation studies is waived because studies are either unsuitable, as for dodecan-1-ol, or technically unfeasible, as for dodecan-1-ol and undecan-1-ol and no reliable measured bioconcentration information is available for these constituents of Alchisor TAL 123. Evidence exists to show that predicted modelled data overestimate bioconcentration because the biotransformation of hydrocarbons and the ready biodegradation of Alchisor TAL 123 are not accounted for. Therefore, based on the criteria of REACH Annex XIII, it can be concluded that Alchisor TAL 123 is not bioaccumulative (B) or very bioaccumulative (vB).

Toxicity: Based on available reliable data for toxicity of constituents of Alchisor TAL 123, The chronic data for dodecan-1-ol show an NOEC = 0.014 mg/L (aquatic invertebrates) and thus does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment (Part C). In a protective approach, the data for dodecan-1-ol have been selected as the most sensitive across the Alchisor TAL 123 constituents. In light of these data, Alchisor TAL 123 does not fulfill the Toxicity criteria as laid down in Annex XIII of regulation (EC) No 1907/2006.

Constituents of Alchisor TAL 123 (namely Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and undecan-1-ol) do not fulfill the criteria for persistence, bioaccumulation or toxicity. The overall conclusion is that Alchisor TAL 123 does not meet the PBT or vPvB criteria. No further testing is required.