Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate for effects in the environment:

 

Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate (CAS no. 40754-59-4) has a wide variety of uses such as intermediate for agrochemicals, dyestuff, chemical synthesis, pharma intermediate. The aim of the PBT assessment was to evaluate whether this chemical fulfils the PBT criterion within Annex XIII. The PBT assessment were based on toxicological information in conjunction with standardized environmental fate- and bioaccumulation 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

The biodegradability of the test substance disodium 4-oxo-2-sulfonato-5,8,11,14-tetraoxahexacosan-1-oate (CAS no. 40754-59-4)was calculated using the Estimation Programs Interface Suite (EPI suite, 2017) in the presence of mixed populations of environmental microorganisms. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called as Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that disodium 4 -oxo-2 -sulfonato-5,8,11,14 -tetraoxahexacosan-1 -oate is expected to be readily biodegradable.

 

Experimental study on read across substances (CAS: 5896-54-8; 822-16-2 and 141-17-3) also indicate the substances to be readily biodegradable

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 73.2%). In soil, Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate was expected to have high mobility based upon a Log KOC of 1.29. 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 low.

 

If released in to the environment, 26.8 % 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 (15 days estimated by EPI suite) indicates that 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% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate 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 of the substance is 70.79 L/kg (EPI Suite version 4.1, 2017) and the octanol water partition coefficient of the test chemical is estimated as 3.65 which is less than the threshold of 4.5. Thus, 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

Most 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 8.76 mg/L to 1330 mg/L indicating that the substance can be classified as hazardous but since the substance is determined to be readily biodegradable, test chemical can be considered as non-hazardous to aquatic organisms as per the CLP criteria.

 

There are no available long-term toxicity evaluations for Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate.

 

By speculation, long-term NOEC for aquatic organisms were not expected for Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate 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.