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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

4,4'-bis(dimethyl amino)-4''-(methyl amino)trityl alcohol
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
4,4'-bis(dimethyl amino)-4''-(methyl amino)trityl alcohol
PBT status:
the substance is not PBT / vPvB

Classification of 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol for effects in the environment:


The chemical 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol (CAS no. 561-41-1) is used as a dye in printing inks and toners.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol. 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

In a prediction done by using the Estimation Programs Interface Suite, the biodegradation potential of the test chemical 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol (CAS no. 561-41-1)in the presence of mixed populations of environmental microorganisms was predicted. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called as Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that chemical 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcoholis expected to be not readily biodegradable.


Experimental results from the read across substances also indicate that they are not readily biodegradable.


Thus, based on the available information, it indicates that chemical 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol can be expected 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 estimated BCF value from authoritative databases was evaluated to beranges from 1 to 835.24, respectively and the octanol water partition coefficient of the test chemical was determined to be 3.447 at 25°C as per OECD TG 117 and from modelling database was estimated to be 3.51, 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:



The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity,

Further, there is evidence of chronic toxicity, as identified and is regarded to be classified in ‘’STOT RE Category 2’’as per theself-classification according to CLP criteria.


Aquatic organisms

All of the available short-term eco-toxicity study as per OECD TG for fish, aq. invertebrate and algae for the substance4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol (CAS no. 561-41-1)indicates the LC50/EC50 value to be 0.257 mg/l to 0.671 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 acute/chronic category 1’ as per the CLP classification criteria.


There are no available long-term toxicity evaluations for the test chemical4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol. By speculation, long-term NOEC for aquatic organisms were 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.



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.