N,N-diethylaniline

PBT assessment

PBT assessment: overall result

Reference

Name:

N,N-diethylaniline

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

N,N-diethylaniline

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of N, N-diethylaniline for effects in the environment:

 

The chemical N, N-diethylaniline (CAS no. 91-66-7) is used in the synthesis of pharmaceuticals and dyes. It is also used for other organic synthesis.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forN, N-diethylaniline.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

The first experimental study have been reviewed from authoritative database (J-check) in this study the test chemical was subjected to biodegradation test by taking sludge as inoculums at 30 mg/L concentration. Biodegradation was analyzed by using two parameters that are BOD and TOC. The initial concentration of test chemical was 100 mg/L and study design was of standard type. After 2 weeks test chemical showed 0.0%, and 1.0 % degradation by   BOD and parameter respectively in two weeks (14 days).On the basis of % degradation values it is concluded that test chemical is not readily biodegradable.

 

Next study was reviewed from Sewage and Industrial Wastes journal (1955) in this study the biodegradation experiment was performed by using to OECD test guideline 301C. The percent degradation of test chemical was determined to be 0.0% in 14 days by using activated sludge as inoculum. On the basis of percent degradation value it is concluded that test chemical is not readily biodegradable in nature.

 

Another study was reviewed from secondary source in this study the percent biodegradation of test chemical was determined to be 0.0% by using BOD as parameter and sewage as inoculums in 5 days at 20⁰C. On the basis of percent degradation value it is concluded that test chemical is not readily biodegradable in nature.

 

Thus, based on the available information, it indicates thatchemicalN, N-diethylanilinecan 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:

 

The BCF value from authoritative databases was determined to be 16 to 161 dimensionless, respectivelyand the octanol water partition coefficient of the test chemical was determined to be 3.90, 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 evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), in ‘Category 2’ (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) as per the CLP Regulation.

  

Aquatic organisms

All of the available short-term eco-toxicity data for fish, invertebrates and algae for the substanceN, N-diethylanilineindicates the LC50/EC50 value to be in the range 2.8 to 42.25 mg/L, respectively. Whereas on the basis ofthelong term eco-toxicity data for fish and aq. Invertebrates, the NOEC value was evaluated to be ranges from 0.936 to 1.252 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 chronic category 2’ as per the CLP regulation.

 

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