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PBT assessment

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PBT assessment: overall result

Reference
Name:
Food Yellow 13
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium saltsfor effects in the environment:

 

The chemical 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts (CAS no. 95193-83-2) is used as a food colour in baked goods, meat and poultry products, soft drinks, beverages, confectionary etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models. Here follows a description of the PBT assessment.

 

Persistence assessment

The tested substance fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

On the basis of experimental result of biodegradation study conducted as per the OECD test guideline 301F for the target chemical 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts (CAS no. 95193-83-2), its percentage degradation was determined to be 2.8% using oxygen consumption as a parameter within 28 days. Thus, it indicates that chemical 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts was considered to be not readily biodegradable in water and hence, likely to be persistent (P) in nature.

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

The octanol water partition coefficient of the test chemical was determined to be -1.548±0.063 at 25°C as per the OECD guideline no. 117, which is less than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

Toxicity assessment

The tested substance does not fulfil the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).

 

Aquatic organisms

All of the available short-term eco-toxicity data for fish, invertebrates and algae for the substance 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts indicates the LC50/EC50 value determined to be > 100 mg/L. These value suggest that the substance is not likely to be hazardous to aquatic organisms at environmentally relevant concentrations and hence, considered to be ‘not classified’ as per the CLP classification criteria.

 

There are no available long-term toxicity evaluations for 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts. By speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above

 

The chemical was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII for PBT assessment.

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound fulfils the P criterion but does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.