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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
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:

Classification of Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts for effects in the environment:

 

The chemical Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts (CAS no. 12237-63-7) is used as a colorant in ink, toner and other products etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) 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 does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

On the basis of various experimental study report results of biodegradation studies for the test chemical Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts (CAS no. 12237-63-7), it indicates that chemical Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts can be considered to be primary inherently biodegradable and thus likely to be not persistent (not 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 estimated BCF value from authoritative database was determined to be 3.162 L/Kg and theoctanol water partition coefficient of the test chemical ranges was determined to be 3.525, respectively, 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 fulfils 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 and aq. invertebrates for the substance indicates the LC50/EC50 value to be in the range 0.022 – 52 mg/L, respectively. Whereas on the basis of the various experimental studies of the test chemical and applying the weight of evidence approach, the EC50 value for algaeof the test chemical Ferrate(4 -), hexakis(cyano-C)-, Et 2 -[6 -(ethylamino)-3 -(ethylimino)-2,7 -dimethyl-3H-xanthen-9 -yl]benzoate copper(2 +) salts can be determined to be in the range 0.13 – 0.61 mg/L, respectively and on the basis ofthelong term eco-toxicity estimated data for fish and aq. invertebrates, the NOEC value was evaluated to be ranges from 0.00000412 mg/l to 0.0000179 mg/l, respectively. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be classified in ‘Aquatic Acute Category 1’ and ‘Aquatic Chronic Category 1’ as per the CLP regulation.

 

The chemical was therefore 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 T criterion, but does not fulfil the P and B criterion and has therefore not been classified as a PBT compound within Annex XIII.