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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:

1. Persistence Assessment:

Disperse Red 302 was found to be not inherently biodegradable in a Modified MITI Test (II). The biodegradation of after 28 days was found to be 13 %. Hence, it could be considered to be persistent (P). 

2. Bioaccumulation Assessment:

The partition coefficient n-octanol/water of Disperse Red 302 at 20 °C was calculated from the individual solubility in water and n-octanol and was determined to log Pow = 6.39. However, several experimental fish bioaccumulation tests for disperse anthraquinone dyes, performed according to test methods specified by the Japanese Ministry of International Trade and Industry (MITI), reported log bioaccumulation factor (BCF) of <0.7 (BCF < 5), expressed on the basis of wet body weight of the fishes (Anliker et al. 1981; Anliker and Moser 1987). Disperse anthraquinone dyes are also known to have large cross sectional diameters which are associated with slow bioaccumulation. These findings were considered to be applicable in case of Disperse Red 302 as well. Hence, the substance is regarded as not bioaccumulative neither fulfilling the B nor the vB criterion.

 

3. Toxicity Assessment:

No long-term studies for marine or freshwater organisms are available. However, the substance was tested with species across trophic levels, that included fish, daphnids and Lemna. Based on the available data from these studies, Disperse Red 302 can be considered as not toxic to aquatic species (EC50 >100 mg/l). Further, the substance is not classified as carcinogenic, mutagenic or reprotoxic according to Regulation (EC) No. 1271/2008. Therefore, based on current knowledge, the substance does not fulfil the T criterion based on the PBT criteria according to Annex XIII of the REACH Regulation.

Based on the above discussion, Disperse Red 302 can be potentially persistent (P), however not considered to fulfil bioaccumulation (neither B nor vB) as well as toxicity (T) criterion, hence it is considered to be neither PBT nor vPvB.