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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of 4-Nonylphenol, branched, ethoxylated for effects in the environment:

 

The chemical 4-Nonylphenol, branched, ethoxylated (CAS no. 127087-87-0) is used for as a surfactant. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 4-Nonylphenol, branched, ethoxylated. 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:

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 90%). In soil, the substance was expected to have low mobility based upon a Log Koc of 2.63. The half-life in sediment and soil (75 days estimated by EPI suite) indicates that the chemical is not persistent in soil.

 

If released in to the environment, 9.39 % of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2016). However, the half-life (60 days estimated by EPI suite) indicates that the substance can be considered persistent in the medium and the exposure risk to aquatic animals is moderate.

 

Moreover, its persistent characteristic is also observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% when estimated by EPI Suite version 4.1). Hence, the substance can be considered as not persistent in sediment.

 

Hence it has been concluded that 4-Nonylphenol, branched, ethoxylated is 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 (EPI Suite, 2017) was determined to 7.86 L/kg wet wt. 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 estimation for fish, invertebrates and algae for the substance indicates the LC50/EC50 value to be in the range 19.5 – 84.7 mg/L. 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 3 as per the CLP regulation.

There are no available long-term toxicity evaluations for 4-Nonylphenol, branched, ethoxylated. Short term NOEL for read across substance Nonylphenol, ethoxylated (CAS: 9016-45-9) in algae is reported as 8 mg/L and LOEC was reported as 16 mg/L in a 96 hr study based on effects on cell number.

By speculation, long-term NOEC for aquatic organisms were not expected for 4-Nonylphenol, branched, ethoxylated 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.