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PBT assessment

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PBT assessment: overall result

Reference
Name:
Reactive Yellow 095 (meta) (boundary composition of the substance)
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT assessment of the assessed substance is partly based on the analogue approach, where the source chemical (i.e. FAT 40000) is the multiconstituent substance of the meta and para isomers of Reactive Yellow 095.

1.Persistence Assessment:

The source substance is not readily biodegradable nor inherently biodegradable. Therefore, the substance should be regarded as only persistent (P) in the environment and not very persistent (vP) in the environment.

 

2.Bioaccumulation Assessment:

The log Pow value of Reactive Yellow 95 (meta) was determined to be < -3.49 using the shake flask method at 20°C.

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 fulfill the B and the vB criterion if its log Kow ≤4.5.

The octanol-water partition coefficient for the test item is log Pow < -3.49. This value is much below the threshold value of log Kow ≤4.5.

In conclusion, 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.

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 source substance, all aquatic toxicity studies in fish, invertebrates, plant and microorganisms showed LC50/EC50/IC50 values above 100 mg/L.

There is no evidence of chronic toxicity from the available repeated dose toxicity study (NOAEL 200 mg/kg bw/d) and the reproductive/ developmental toxicity screening study (NOAEL 400 mg/kg bw/d). The source substance is neither 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.