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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:

Classification of for Tris(5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-)) dialuminium effects in the environment:

 

Tris(5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-)) dialuminium(CAS no. 68475-50-3) is used in dyestuff application. The aim of the PBT assessment was to evaluate whether this chemical fulfils the PBT criterion within Annex XIII. The PBT assessment were based on toxicological information in conjunction with standardized environmental fate- and bioaccumulation 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

Biodegradation in water ability was predicted for the test substance Tris(5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-)) dialuminium (CAS no. 68475-50-3) using the OECD QSAR prediction model. The ready biodegradability of the test substance Tris(5-amino-4- hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-))dialuminium was estimated as 0.8% in 28 days by using BOD parameter. This result indicates that Tris(5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-)) dialuminium was estimated to be not readily biodegradable in water.

 

The ultimate biodegradation estimate in the Biowin model (EPI suite version 4.1) shows thatTris(5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-)) dialuminiumis not readily biodegradable (Biowin 2= 0.0000, BIOWIN 3= 2.1910, BIOWIN 6= 0.0000).

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 74.7%). The Koc-value was estimated to 41950 at 25ºC (KOCWIN program) indicating negligible mobility and very high adsorption potential.

The tested chemical is therefore not expected to leach from soil. The half-life in soil (120 days estimated by EPI suite) indicates that the exposure risk to soil-dwelling organism should therefore be moderate to high.

 

If released in to the environment, 19.1 and 6.11 % of the chemical will partition into sediment and water respectively, according to the Mackay fugacity model level III in EPI suite version 4.1 (2016). However, the half-life (541.66 days in sediment and 60 days in water estimated by EPI suite) indicates that the exposure risk to sediment dwelling and aquatic animals is moderate.

 

On the basis of the above mentioned half-life values, the chemical is classified as a persistent chemical (P) but not very persistent (not vP) since only estimated half-life values for the same are available.

                                                                                                      

Bioaccumulation assessment

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

 

The BCF value is estimated to be 3.162 L/kg (calculated by EPI suite version 4.1, 2016) and the estimated Log Kow values are 0.4845 at 25ºC (EPI suite version 4.1, 2016). 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 available short-term eco-toxicity estimation for fish, invertebrates and algae for the substance indicates the LC50/EC50 value are above 100 mg/L indicating that the substance is classified as non-hazardous as per the CLP criteria.These values suggest classification for aquatic toxicity will not be applicable for all of the tropic levels.The chemical was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

 

Conclusion

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