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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:
ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
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 the various experimental study resultsofbiodegradation studies of 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) performed as per the OECD TG / other test guideline methods;chemical was considered to be inherently biodegradable in water 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 the octanol water partition coefficient of the test chemical was determined to be 3.525 ± 0.006 at 25°Cas per the OECD guideline no. 117, 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

On the basis ofthe available short andlong term eco-toxicity data of the substance 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) for fish, aq. invertebrates and algae, the NOEC value organisms were expected at concentration below 0.01 mg/l.

 

Thus, 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.