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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 Disulfo copper phthalocyanine amine salt for effects in the environment:

 

The chemical Disulfo copper phthalocyanine amine salt (CAS no. 1328-51-4) is used for dyestuff application and as a stain for biological staining. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Disulfo copper phthalocyanine amine salt. 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

Estimation Programs Interface Suite (EPI suite, 2017) was run to predict the biodegradation potential of the test compound Disulfo copper phthalocyanine amine salt (CAS no. 1328 -51 -4) in the presence of mixed populations of environmental microorganisms. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI LInear Model, MITI Non-Linear Model and Anaerobic Model (called as Biowin 1 -7, respectively) of the BIOWIN v4.10 software. The results indicate that Disulfo copper phthalocyanine amine salt is expected to be not readily biodegradable.

Hence it has been concluded that Disulfo copper phthalocyanine amine salt is likely to be persistent in nature.  

 

Bioaccumulation assessment

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

 

The estimated bioconcentration factor (BCF) was reported as 536.1 L/kg (EPI Suite, 2017) and the estimated octanol-water partition coefficient (Log Kow) is reported as 3.86. If this chemical is released into the aquatic environment, there should be a moderate 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 estimation for invertebrates and algae for the substance indicates the LC50/EC50 value are above 100 mg/L. These value suggest that the substance is not likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be not classified as per the CLP regulation.

There are no available long-term toxicity evaluations for Disulfo copper phthalocyanine amine salt

By speculation, adverse effects at environmentally relevant concentrations in freshwater species were not expected for the substance based on the determined acute EC50 above 10 mg/L (from 2 trophic 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 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.