Registration Dossier
Registration Dossier
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EC number: 207-668-4 | CAS number: 488-10-8
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment of (Z)-3-methyl-2-(pent-2-en-1-yl)cyclopent-2-enone (CAS 488-10-8) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence
Experimental guideline tests showed that the substance is readily biodegradable. Thus, the substance does not meet the screening criterion for persistence and is not P or vP.
Bioaccumulation
In accordance with ECHA Guidance document R.11 (ECHA, 2017) (Z)-3-methyl-2-(pent-2-en-1-yl)cyclopent-2-enone (CAS 488-10-8) is not considered to meet the screening criterion for bioaccumulation since the log Kow is 2.8 (pH 7, OECD 117, HPLC method). However, according to ECHA Guidance R.11 (ECHA, 2017) there is indication that accumulation in air breathing organisms may occur based on the calculated log Koa of 5.11 (KOAWIN v1.10). The guidance clearly indicates that this partition coefficient combination relates to biomagnification potential only when predicated on the assumptions of high chemical absorption efficiency from diet, no biotransformation after absorption and negligible active transport (in or out). Consequently, considerations for absorption efficiency and biotransformation rates are thus also necessary for bioaccumulation assessment.
Based on the physico-chemical properties, the substance is expected to preferentially distribute into the water compartment and no significant evaporation to air is expected (vapour pressure: 0.91 Pa, 20 °C, OECD 104). The experimentally determined log Kow of 2.8 indicates that the substance has low lipophilicity. Moreover, the substance is readily biodegradable. Therefore, absorption by both aquatic and terrestrial organisms is expected to be low. This is further supported by the estimated log BCF (EPI Suite v4.11, Arnot-Gobas, including biotransformation, upper trophic) of 1.697 (BCF = 49.82 L/kg wet-wt), which is clearly below the trigger value of 2000 L/kg wet-wt for the B or vB criterion. Therefore, it is concluded that the overall bioaccumulative potential of the substance is low.
In conclusion, the trigger values for biomagnification in air-breathing (terrestrial) organisms as stipulated by the ECHA Guidance R.11 likely overestimate the potential for biomagnification in the food chain.
Toxicity
For (Z)-3-methyl-2-(pent-2-en-1-yl)cyclopent-2-enone (CAS 488-10-8) the available acute effect concentrations are clearly≥ 0.1 mg/L (fish, aquatic invertebrates and algae) and the chronic effect concentration for algae is clearly ≥ 0.01 mg/L. The substance is readily biodegradable and has a log Kow < 4.5. Therefore, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the substance does not meet the T criterion.
In conclusion, the substance is not PBT/vPvB.
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