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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)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) saltsfor effects in the environment:

 

The chemicalFerrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts(CAS no. 12237-62-6) is used as a pigment in ink, toner and colorant products etc.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forFerrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine 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 fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

28-days biodegradation test following the EU Method C.5 (Degradation: Biochemical Oxygen Demand) was performed to determine the ready biodegradability of the test chemical. Bacteria was used as a test inoculum for the study. Bacteria was collected from activated sludge of the sewage treatment plant of CH-4106 Therwil on 16/10/89 The preparation was carried out according to the method described in the guideline. Aniline (20 mg//l) was used as a reference substance for the study. 1200 ml of the mineral solution with the inoculum were aerated for 24 hours in the test vessel. In 300 ml mineral solution 0.5 ml Nonylphenol 10EO5PO (solution of 30 mg in 100 ml bidist. water) and 16.3 rsp. 47.1 mg of test substance were added and homogenized. This solution was given to the test vessel which was immediately connected to the CO2 traps. The CO2 formed by biodegradation was absorbed with NaOH and determined on a carbon analyzer. Due to the poor solubility of the test substance in water, an emulsifier was used to achieve a better distribution in the medium. Determination of the initial CO2 of the 0.05 N sodium hydroxide and the CO2, absorbed in the absorbers filled with 200 ml 0.05 N sodium hydroxide was carried out on the days 3, 7, 10, 13, 17, 20, 24, 27 and 28, respectively. The biodegradation was calculated on the basis of the theoretical carbon content of the test substance and the cumulative quantities of carbon dioxide determined on the days of measurements. The percentage degradation of test substance was determined to be 6.0 and 4.0% (using 10.9 and 30.4 mg/l conc. of test substance) by using CO2 evolution parameter in 28 days. Thus, based on percentage degradation, test chemical is considered to be not readily biodegradable in nature.

 

Thus, based on the available information, it indicates thatchemicalFerrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) saltscan be considered to be not readily biodegradable in water and thus 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:

 

Theoctanol water partition coefficient of the test chemical was determined to be 4.66 as per OECD Guideline No. 117, which is close to 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 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, invertebrates and algae for the substanceFerrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) saltsindicates the LC50/EC50 value to be in the range 6.5 mg/l to 14 mg/L, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations and hence, considered to be classified in ‘Aquatic chronic category 2’ as per the CLP regulation.

 

On the basis ofthelong term eco-toxicity data for fish and aq. Invertebrates, the NOEC value was evaluated to be 3 and 1.9 mg/l, respectively. 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.

 

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 hence, therefore not been classified as a PBT compound within Annex XIII.