Castor oil, ethoxylated

PBT assessment

PBT assessment: overall result

Reference

Name:

Castor oil, ethoxylated

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

Castor oil, ethoxylated

Reference substance:

Castor oil, ethoxylated

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Castor oil, ethoxylatedfor effects in the environment:

 

The chemical Castor oil, ethoxylated (CAS no. 61791-12-6) is used in water treatment chemicals, biocidal products, lubricants-greases, leather tanning, dyeing, finishing products, cosmetics-personal care products, emulsifiers, washing-cleaning products, metal surface treatment products (including those for galvanizing and electroplating) etc. It is also used as an inert ingredient in non-food pesticide products. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Castor oil, 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:

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 82.3%). In soil,Undec-10-enalwas expected to have negligible mobility based upon a Log KOC value ranging from 7 to 11.2, respectively. The half-life in soil (75 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, 17.7% 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 (37.5 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 0.00393% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that Castor oil, 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 be 3.162 L/kg and the octanol water partition coefficient of the test chemical was determined to be 4.297, 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:

 

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 aq. invertebrates of the substanceCastor oil, ethoxylatedindicates the LC50/EC50 value to be 7.33 to > 25 mg/l, respectively and on the basis ofthe various experimental studies of short term 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 6.61 to 230 mg/l, respectively and on the basis of the available data oflong term eco-toxicity data for fish and aq. Invertebrates of the substance Castor oil, ethoxylated, the NOEC value was determined to be ranges from 0.00000000129 to 0.0000000016 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 chronic category 1’ as per the CLP regulation.

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.

 

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound fulfils the T criterion, but does not fulfil the P and B criterion and has therefore not been classified as a PBT compound within Annex XIII.