Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

Classification of 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride for effects in the environment:


The chemical 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride (CAS no. 6441-82-3) is used in inks, paper, textile and agrochemicals etc. Also used for making inks, typewriter ribbons and dyeing leather.It is mainly used to dye the wool, acrylic fiber acrylic scattered and compared acrylic fibers, also can be used in the two vinegar and acrylic fiber direct printing.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride. 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

Biodegradation study was conducted to determine the degradation of chemical 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3- trimethyl-3H-indolium chloride by methanogenic bacteria. Anaerobic granular sludge was used in the test. Serum vials with butyl rubber stoppers were used to test biodegradability of the dyes. Basal medium M9 was used in the study. Test conducted at various conc. 0, 300, 600, 1200 & 2400 mg/l. For each dye and each conc. 4 replicate vials were prepared. Methane & hydrogen production were monitored in each vial every 24 h for 3 or 4 days. As chemical shows high toxicity on methanogenic bacteria (anaerobic granular sludge) & kill 100% bacterial growth at all concentrations after 72hrs, no biodegradation was observed by the bacteria. Based on result, 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3- trimethyl-3H-indolium chloride was not biodegradable.


EPI Suite was run to predict biodegradation potential of compound   2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl- 3H-indolium chloride in presence of mixed populations of environmental micro-org. The biodegradability of substance was calculated using 7 different models. The results indicate that chemical 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl] -1,3,3-trimethyl-3H-indolium chloride is expected to be not readily biodegradable.


Biodegradability of 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride is predicted using OECD QSAR toolbox v 3.3 with logKow as primary descriptor. Test substance undergoes 0.58000 % degradation by BOD in 28 days. Thus, based on % degradation, 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride was estimated to be not readily biodegradable in water.


Experimental results from read across substances (CAS: 127-90-2 & 2939-80-2) also indicate that they are not readily biodegradable.

Based on the available information, it has been concluded that 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride is likely to be 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 in the range 3.162 to 636, respectively and the octanol water partition coefficient of the test chemical is 2.6672 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 does not fulfil the T criterion within Annex XIII based on the assessment that here follows:



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 invertebrates and algae for the substance indicates the LC50/EC50 value to be in the range 195.2– 279.64 mg/L, respectively and the EC0 value for fish toxicity was determined to be 5.0 mg/l, respectively. These value suggest that the substance is not likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be ‘not classified’ as per the CLP regulation.


By speculation, long-term NOEC for aquatic organisms were not expected for the substance 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride 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.



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