Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

According to Annex XIII of the REACH Regulation (EC n. 1907/2006), a substance is PBT if it fulfills all three of the following criteria.

1) Persistence

A substance fulfills the persistence criterion (P) when:

– the half-life in marine water is higher than 60 days, or

– the half-life in fresh- or estuarine water is higher than 40 days, or

– the half-life in marine sediment is higher than 180 days, or

– the half-life in fresh or estuarine water sediment is higher than 120 days, or

– the half-life in soil is higher than 120 days.

The assessment of the persistency in the environment shall be based on available half-life data collected under the adequate conditions, which shall be described by the registrant.

2) Bioaccumulation

A substance fulfills the bioaccumulation criterion (B) when:

– the bioconcentration factor (BCF) is higher than 2000.

The assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from freshwater as well as marine water species can be used.

3) Toxicity

A substance fulfills the toxicity criterion (T) when:

– the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is less than 0.01 mg/l, or

– the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or

– there is other evidence of chronic toxicity, as identified by the classifications.

The substance is not persistent as it is readily biodegradable. The substance is not expected to bioaccumulate as it has a calculated partition coefficient value of log KOW = 1.81. The substance is not toxic based on an EC10 value (72h, algae) greater than 0.01 mg/L (due to quick degradation of the substance in water), it is not carcinogenic/mutagenic/toxic to reproduction (i.e., is not CMR) and has no other evidence of toxicity (including none of the following classifications: T, R48, Xn, STOT RE 1 or 2).

Therefore, the substance is not PBT or vPvB. Additionally, degradation products provide no concern regarding PBT.