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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:

The ECHA guidance document R.11 gives the criteria to be used in the assessment of PBT and vPvB properties. These include also screening criteria for the assessment of persistence and bioaccumulation potential.

A substance is considered as persistent in the environment if its half-life in fresh or estuarine water is greater than 40 days, or in marine water is greater than 60 days, or in fresh sediment, estuarine sediment or soil is greater than 120 days or in marine sediment is greater than 180 days. Screening criteria have been established for the assessment of the persistence of a substance in the environment based on ready, enhanced ready and specified inherent biodegradation tests. According to ECHA guidance document R.11, a substance which achieves 60% in a ready or an enhanced ready test is not fulfilling the criteria for persistence. For the specified inherent tests, a pass level of 70% within 7 d (OECD302B) and within 14 days (OECD301C) is required to confirm not P.

A substance is considered as bioaccumulative if the bioconcentration factor is greater than 2000 L/kg. A screening criterion has been established for the assessment of the bioaccumulation potential of a substance, which is a log Kow greater than 4.5. According to ECHA guidance document R.11, for organic substances with a log Kow value below 4.5 it is assumed that its bioconcentration factor, i.e. its affinity to partition into the lipids of organisms, is below 2000 L/kg.

A substance is considered as toxic if the long-term NOEC for marine or freshwater organisms is less than 0.01 mg/L, the substance is classified as carcinogenic, mutagenic or toxic for reproduction, or there is evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC. A screening criterion for environmental toxicity has been established for substances, for which long-term tests are lacking. According to ECHA guidance document R.11, a substance is considered to potentially meet the criteria for toxicity when an acute E(L)C50 value from a standard toxicity test is less than 0.1 mg/L.

Persistence Assessment

As the substance was found to be readily biodegradable in a screening test on ready biodegradability, it therefore does not fulfil the criteria for Persistence.

Bioaccumulation Assessment

As the log Kow of Cyclamen aldehyde is 3.4, the substance is likely to have a BCF below 2000 kg/L. The substance does not fulfil the criteria for Bioaccumulation.

Toxicity Assessment

None of the available standard toxicity tests in fish, daphnids or algae resulted in E(L)C50 values of less than 0.1 mg/L. The substance is not carcinogenic, mutagenic or toxic for reproduction. Finally, the substance is not classified for chronic toxicity. The substance does not fulfil the criteria for Toxicity.

Summary and overall Conclusions on PBT or vPvB Properties

The substance does not fulfil the PBT or vPvB criteria and therefore is not PBT or vPvB.