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PBT assessment

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PBT assessment: overall result

Reference
Name:
Reactive Yellow 039
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
>= 70 - <= 85 % (w/w)
Reference substance:
Composition 1
Reference substance:
Composition 1
This impurity is considered relevant for the classification and labelling of the substance
PBT status:
the substance is not PBT / vPvB
Justification:

1.Persistence Assessment:

The BOD5/COD ratio for FAT 40061/A and FAT 40061/D was below 0.5. Further, 0 % bioelimination was observed for FAT 40061/D in a Zahn Wellens. Hence, based on experimental data the Reactive Yellow 039 is considered to be niether readily nor inherently biodegradable. Thus, it could not be denied that it may persist in the environment.

2.Bioaccumulation Assessment:

The partition coefficient n-octanol/water of FAT 40061/F at 20 °C, calculated from the individual solubility in water and n-octanol, was determined to be log Pow = -4.74. According to the screening criteria for bioaccumulation (B for bioaccumulative, vB for very bioaccumulative) given in the technical guidance provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance does not fulfil the B and the vB criterion if its log Kow ≤4.5. Hence, Rective Yellow 039 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. According to the screening criteria provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance has to be considered to fulfil the criteria for toxicity (T for toxicity) if the EC50 or LC50 of a short-term aquatic toxicity test is below 0.1 mg/L. For the substance under consideration, the EC50/L50 values were >100 mg/L. Further, there is no evidence of chronic toxicity from the available combined repeated dose and reprotoxicity/developmental screening study (OECD 422) and it is not classified as carcinogenic, mutagenic or toxic for reproduction. 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.

Conclusion:

Reactive Yellow 039 may be considered to be persistent, however it does not fulfil the bioaccumulation as well as toxicity criteria, hence it is not considered to be PBT/vPvB.