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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 CAL 145 comprises alkenes C13-14 hydroformylation products, distn. residues with read-across from the chemically-similar Alchisor CAL 123 as defined in the Read-Across Justification Document (see Section 13 of IUCLID). Where environmental fate data exist for Alchisor CAL 123, these are representative of the Alchisor CAL 145 substance.

Alchisor CAL 123 can be characterised as alkenes C11-C12 hydroformylation products and does not fulfil the screening criteria for persistence, bioaccumulation, and toxicity. The overall conclusion is that Alchisor CAL 123 and Alchisor CAL 145 via read-across do not meet the PBT or vPvB criteria. No further testing is required.

Persistence (P) Assessment:

Results of the ready biodegradability tests with the read-across substance Alchisor CAL 123 demonstrate that it is readily degraded in fresh waters Schaefer and Matthews (2010) The test substance biodegraded to an extent of 87.7% after 28 days and although the biodegradation rate just missed the 10‐day window threshold, this aspect of the test is not applicable to mixtures where different components of the mixture can biodegrade preferentially (reference TG 103C). Alchisor CAL 123 can be regarded as readily biodegradable. Consequently in line with the detailed guidance Alchisor CAL 123 and Alchisor CAL 145 via read-across do not fulfil the criteria for Persistence (P).

Bioaccumulation (B) Assessment:

Alchisor CAL 123 cannot be regarded as bioaccumulative in aquatic, sediment or terrestrial organisms, Alchisor CAL 123 and Alchisor CAL 145 via read-across do not fulfil the criteria “bioaccumulative (B)” or “very bioaccumulative (vB)”. According to ECHA Guidance on information requirements and chemical safety assessment (May 2008), Chapter R.11, Figure 11‐2: Integrated testing strategy for Bassessment, no further testing is required to conclude on the bioaccumulation criterion.

Toxicity (T) Assessment:

Based on available reliable data for toxicity Alchisor CAL 123 short‐term acute toxicity (LC50 or EC50) to aquatic organisms is >0.01 mg/L and does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment (Part C). Chronic data on aquatic species showed No effect concentrations NOECs >0.01 mg/l and therefore the criteria of Annex XIII REACH for aquatic toxicity are not fulfilled. Therefore, it can be concluded that the substance as well as Alchisor CAL 145 via read-across do not fulfil the Toxicity criteria as laid down in Annex XIII of regulation (EC) No 1907/2006.