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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 Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylatedfor effects in the environment:

 

The chemical Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated (CAS no. 25322-68-3)is used as water-soluble lubricants for rubber molds, textiles, metalworking, and ceramics production. It is also used in food packaging, water-based paints, polishes, paper coatings, ointments, suppositories, dispersing agents, and chemical intermediatesetc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, 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 does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

On the basis of experimental study result for the test chemical Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated (CAS no. 25322-68-3), it indicates thatchemicalPoly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylatedcan be considered to be readily biodegradable in water and thus likely to be not persistent (not P) in nature.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 69.4%). In soil,Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylatedwas expected to have moderate mobility based upon a Log KOC value of 1.856, respectively. The half-life in soil (30 days estimated by EPI suite) indicates that the chemical is not persistent in soil and the exposure risk to soil dwelling animals is moderate to low.

 

If released in to the environment, 30.6% of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). However, the half-life (15 days estimated by EPI suite) indicates that the chemical is not persistent in water and the exposure risk to aquatic animals is moderate to low.

 

Moreover, its persistent characteristic is only observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% i.e. reported as 0.0688% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated is not 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 databases was determined to beranges from 1 to 3.162, respectively and the octanol water partition coefficient of the test chemical was determined to be ranges from -0.958 to -0.698, 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 and invertebrates for the substancePoly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylatedindicates the LC50/EC50 value to be in the range > 100 mg/L and on the basis ofthe various experimental studies of shortterm eco-toxicity data for algaeof the structurally and functionally similar read across chemical (including the biodegradability of read across chemical) and applying the weight of evidence approach, the EC50 value was determined to be ranges from > 100 to 1000 mg/L, respectively. These value suggest that the substance is likely to be not hazardous to aquatic organisms at environmentally relevant concentrations and can be considered to be ‘not classified’ as per the CLP regulation.

 

On the basis ofthe various data oflong term eco-toxicity data for fish and aq. invertebrates, the NOEC value was determined to be 13671.5 to 17475.2 mg/l and LC50 value was determined to be 1150 mg/l, respectively. 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 does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.