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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 Red 239 displayed very low biodegradability (3.7%) in a ready biodegradability test. This indicates that it is unlikely to achieve a half life of less than 40 or 60 days within fresh water or marine water, respectively, attributed to ready biodegradation alone. However, the substance showed hydrolysis at environmentally relevant pH’s (pH 4: t1/2 =96 days, pH 7: t1/2 = 9.6 days, pH 9: t1/2 < 1 day at 25°C), indicating the potential for significant removal by hydrolysis. As such, degradation is anticipated via this route. Studies on direct phototransformation in water are not available but it is assumed on the basis of chemical structure and nature of use that the substance is not degraded by direct photolysis. It is concluded, therefore, that abiotic processes would contribute significantly to the depletion of the substance within the environment. 

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 Red 239 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 Red 239 has a measured log Pow of < -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 long term toxicity studies in daphnia and algae. The substance is not considered as harmful to aquatic organisms. The substance did not 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