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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:

Persistence Assessment

Reactive Blue 19 displays slow biodegradability based on a Standversuch with a liquid preparation of Reactive Blue 19 (>70% biodegradability after 27 days), a read-across study with the parabase form Reactive blue 19:1 (30-40% biodegradability after 28 days) and a QSAR evaluation (Does Not Biodegrade Fast (BIOWIN v4.10)), however, the substance showed hydrolysis at environmentally relevant pH’s (pH 7 half-life 9.8 days at 25°C; pH 9 half-life 0.1 days at 25°C), indicating the potential for significant removal by hydrolysis. As such, degradation is anticipated predominantly via this route. Due to the effects of hydrolysis at environmentally relevant pH’s adding to the slow biodegradation, it is proposed that the substance cannot be considered to have a half-life in fresh water higher than 40 days.

Based on its high water solubility, low partition coefficient and fairly rapid hydrolysis rate at environmentally relevant pH’s, it can be concluded that it is unlikely that Reactive Blue 19 could potentially be persistent within the environment. Abiotic effects will result in eventual removal from the environment and hence significant contact with the organisms in the food chain can be considered to be minimised. As such, the substance does not fulfil the requirements of Annex XIII, Para 1.1 based on evaluation of available data, and cannot be considered a “P” and “vP” based in this data.

 

Bioaccumulation Assessment

Reactive Blue 19 has a measured log Kow of -7.2. This value indicates that possible bioaccumulation in the food chain is not anticipated. Given the fact that the substance is subject to hydrolysis at biologically relevant pH’s, it is anticipated that bioaccumulation of the substance itself would not occur, as hydrolytic effects in association with metabolic effects would result in removal of the substance.

Based on the physico-chemical and environmental data for the substance, it is proposed that the substance does not fulfil the requirement of Annex XIII, Para 1.2 based on evaluation of available data, and cannot be considered a “B” or “vB” based on the available data.

 

Toxicity Assessment

The substance did not cause any hazardous effects to any of the trophic levels in the aquatic organisms examined in the acute toxicity studies. The substance is not considered as harmful to aquatic organisms, nor did it demonstrate significant toxicity in any of the mammalian studies conducted on the substance. 

As such, the substance does not fulfil the requirements of Annex XIII, Para 1.3 based on evaluation of available data, and cannot be considered as “T” for the purposes of the assessment.

 

Summary and overall Conclusions on PBT or vPvB Properties

The substance cannot be considered to fulfil all the criteria for Persistence, Toxicity or Bioaccumulation, as specified in REACH Annex XIII. As such, the substance cannot be considered a PBT or vPvB substance, based on the available data.

Likely routes of exposure:

Not applicable