Registration Dossier
Registration Dossier
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EC number: 935-454-7 | CAS number: 68516-18-7
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence: From a comparison of the results obtained for the structural analogue,Alchisor CAL 123, with the criteria of REACH Annex XIII, it can be concluded that Alchisor CAL 111 is not persistent (P) under aerobic conditions.
Bioaccumulation:Alchisor CAL 111cannot be regarded as bioaccumulative in aquatic, sediment or terrestrial organisms. Reliable experimental studies with the analogue, Alchisor CAL 123, indicate that the substance is both readily biodegradable and poorly soluble. Direct and indirect exposure is therefore unlikely as the substance would not likely be bioavailable. Additional evidence (as reported in SIDs LCA Report and LCA Category for REACH) concludes that it is expected that category members will have a low potential for bioaccumulation. Therefore, based on the criteria of REACH Annex XIII, it can be concluded that Alchisor CAL 111 is not bioaccumulative (B) or very bioaccumulative (vB).
Toxicity: Based on available reliable data for toxicity, the analogue, Alchisor CAL 123, short-term acute toxicity (LC50or 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 (expressed as NOEL) >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 does not fulfill the Toxicity criteria as laid down in Annex XIII of regulation (EC) No 1907/2006.
The overall conclusion is thatAlchisor CAL 111does not meet the PBT or vPvB criteria. No further testing is required.
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