Sorbitan monostearate, ethoxylated

PBT assessment

PBT assessment: overall result

Reference

Name:

Sorbitan monostearate, ethoxylated

Type of composition:

boundary composition of the substance

State / form:

liquid

Reference substance:

Sorbitan monostearate, ethoxylated

Reference substance:

Sorbitan monostearate, ethoxylated

PBT status:

the substance is not PBT / vPvB

Justification:

Classification ofSorbitan monostearate, ethoxylated for effects in the environment:

 

The chemical Sorbitan monostearate, ethoxylated (CAS no. 9005-67-8) is used as a flavoring agent, emulsifier, boiler water additive, surface-active agent, and stabilizer or thickener for foods. It is also used in cosmetics, pharmaceuticals, as a lubricant and finish emulsifier for textile and leather manufacture, laboratory reagent, and flavouring etc.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forSorbitan monostearate, 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 the various experimental results of biodegradation studies for the test chemical Sorbitan monostearate, ethoxylated (CAS no. 9005-67-8), it indicates that chemical Sorbitan monostearate, ethoxylated can be considered to be inherently 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 83.8%). In soil,Sorbitan monostearate, ethoxylatedwas expected to have slow mobility based upon a Log KOC value of 3.08, 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, 15.1% 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 2% i.e. reported as 1.02% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that Sorbitan monostearate, 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 be184.1 L/Kg, respectively and the octanol water partition coefficient of the test chemical was estimated to be 3.93, 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 for the substance Sorbitan monostearate, ethoxylated indicates the LC50/EC50 value to be in the range 240 to > 1000 mg/L, respectively and on the basis ofthe various experimental studies ofshort term eco-toxicity data for aq. invertebrates and aq. 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 > 13 to 150 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 of the various experimental studies oflong term eco-toxicity data for fish and aq. Invertebratesof the structurally and functionally similar read across chemical (including the biodegradability of read across chemical) and applying the weight of evidence approach, the NOEC value was determined to be ranges from 0.48 to > 5 mg/l and EC50 value was determined to be ranges from 0.55 to > 50 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.