1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts

PBT assessment

PBT assessment: overall result

Reference

Name:

E104 Quinoline Yellow

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Related composition:

E104 Quinoline Yellow

Reference substance:

E104 Quinoline Yellow

Reference substance:

E104 Quinoline Yellow

Reference substance:

E104 Quinoline Yellow

Reference substance:

E104 Quinoline Yellow

Reference substance:

E104 Quinoline Yellow

Reference substance:

E104 Quinoline Yellow

PBT status:

the substance is not PBT / vPvB

Justification:

The PBT assessment for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT/ vPvB assessment” (ECHA, 2017).

 

Persistence

The substance is not readily biodegradable. Hydrolysis in environmental conditions is also not expected. Thus, the test substance meets the screening criterion for persistence and it could be considered to be P or vP.

 

Bioaccumulation

The substance is not expected to bio-accumulate based on the low LogKow and on the predicted BCF value. The uptake of an organic substance is driven by its hydrophobicity. For organic substances with a Log Kow value below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 (based on wet weight of the organism, which refers to fish in most cases) (Chapter R.11, version 3.0, June 2017). The substance has a LogKow≤-2 and the predicted BCF of the substance (estimated using EPisuite BCFBAF v 3.01) is much lower than BCF threshold value for bioaccumulation (2000 L/kg). Thus, the substance is not considered to be B or vB.

 

Toxicity

No long-term toxicity data are available for the aquatic organisms. In the short-term aquatic toxicity studies, no hazard is identified. Studies on the acute oral toxicity of the substance showed that it is not expected to be toxic after an acute exposure. The substance is not classified for repeated dose toxicity, reproductive toxicity, carcinogenicity or mutagenicity. Therefore, the substance is not considered to be T(oxic).

 

The substance is not considered as PBT as, although meeting the criterion for Persistency (P), does not meet the criteria for Bioaccumulation (B) and Toxicity (T).