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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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Name:
Acid Red 018
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Name:
Acid Red 018
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

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

1) Persistence

A substance fulfils 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 2 000.

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 fulfils 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 fails to fulfil the bioaccumulation criterion. Based on a partition coefficient of log Pow = -2.2671 at 20 °C, a potential for bioaccumulation may be excluded. Indeed, threshold value of potential for bioconcentration is log Pow = 4 as indicated in the CLP Regulation (EC 1272/2008). Therefore, the substance is not PBT.

According to Annex XIII of the REACH Regulation (1907/2006), a substance is vPvB if it fulfils the following criteria.

1)Persistence

A substance fulfils the very persistence criterion (vP) when:

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

- the half-life in marine, fresh or estuarine water sediment is higher than 180 days, or

- the half-life in soil is higher than 180.

2)Bioaccumulation

A substance fulfils the very persistence criterion (vP) when:

- the bioconcentration factor is greater than 5000.

Based on a partition coefficient of log Pow = -2.2671 at 20 °C, a potential for bioaccumulation may be excluded. Therefore, the substance is not vPvB.