4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride for effects in the environment:

 

The chemical4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride(CAS no. 6358-36-7) is used in dyestuff applications.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride. 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

35-days Closed Bottle test following the OECD guideline 301D to determine the ready biodegradability of the test item 4,4'-carbonimidoylbis[N,Ndiethylaniline]monohydrochloride, CAS No. 6358-36-7. The test system included control, test item and reference item. The concentration of test and reference item ( Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % Degradation was calculated using the values of BOD and ThOD for test item and reference item. The BOD35 value of 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride, CAS No. 6358-36-7 was observed to be 0.52 mgO2/mg. ThOD was calculated as 2.31 mgO2/mg. Accordingly, the % degradation of the test item after 35 days of incubation at 20 ± 1°C according to Closed Bottle test was found to be 22.51%. Based on the results, the test item, under the test conditions, was considered to be primary inherent biodegradable.

 

Thus, based on the above available information, it has been concluded that4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochlorideis likely to be not 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 BCF value from authoritative database was determined to be ranges from 22-22.33, respectivelyand the octanol water partition coefficient of the test chemical ranges from 1.757 to 2.55, 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 estimations for fish, invertebrates and algae for the substance indicates the LC50/EC50 value to be in the range 0.116 – 1.925 mg/L. 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 ‘Chronic Category 1’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations for4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride. 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 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.