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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
PBT status:
the substance is not PBT / vPvB

Classification of 2-amino-4-nitrophenolfor effects in the environment:


The chemical 2 -amino-4 -nitrophenol (CAS no. 99 -57 -0) is used in dyestuff synthesis. It is also used as an intermediate in organic synthesis. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 2 -amino-4 -nitrophenol.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

On the basis of various experimental result of the test chemical 2-amino-4-nitrophenol from peer reviewed journals and predicted data, it indicates that the test chemical is not readily biodegradable in water.


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


Thus, based on the available information, it indicates that chemical 2-amino-4-nitrophenol can 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 estimated BCF value from authoritative and modelling databases was evaluated to be ranges from 1 to 5, respectivelyand the octanol water partition coefficient of the test chemical was determined to be 1.26, 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 classified for carcinogenicity in ‘Category 2‘ as per the CLP Regulation.


The tested chemical is regarded to be not classified for 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, aq. invertebrates and algae for the substance2-amino-4-nitrophenolindicates the LC50/EC50 value to be in the range 0.039 mg/l to 90.98 mg/L, respectively. These value suggests 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/ Aquatic Chronic Category 1’ as per the CLP regulation.


There are no available long-term toxicity evaluations for chemical 2-amino-4-nitrophenol. 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.