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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
3-aminophenol
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
3-aminophenol
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of 3 -Aminophenol for effects in the environment:

 

The chemical 3-Aminophenol (CAS no. 591-27-5) is used as a dye intermediate and intermediate for the synthesis of pharmaceuticals. It is used as a stabilizer of chlorine-containing thermoplastics. Also used in hair dyes and an ingredient in chelating resins for removing heavy metal ions from industrial water water etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for3-Aminophenol. 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 results of biodegradation studies for the target chemical3-Aminophenol(CAS no. 591-27-5), it indicates that3-Aminophenolcan 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 database was determined to be ranges from 4 to 40 L/Kg, respectivelyand the octanol water partition coefficient of the test chemical was determined to be ranges from0.15 to 0.22, 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 does not fulfil 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 data for fish, invertebrates and algae for the substance 3-Aminophenolindicates the LC50/EC50 value to be in the range 0.267 to 160 mg/L, respectively and on the basis of long term eco-toxicity data for fish and aq. invertebrates, the LC50 value was determined to be ranges from 0.116 to > 100 mg/l, respectively and NOEC value was determined to be in the range 0.05 to 50 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 Acute Category 1’ and ‘Aquatic Chronic Category 1’ 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 criterion but does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.

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