Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Environmental Fate

It should be noted that the test substance is not considered as posing a hazard to the aquatic environment.

 

The test substance, H112339, is a solid under all environmental conditions and is highly soluble in water (310,000 mg/l). It has a low volatility (based on a vapour pressure result of < 10E-05 hPa at 25 °C) and a low affinity for soil / sediment (based on the soil adsoption coefficient value of Log Koc 3.57). As such, any environmental release will result in virtually all of the substance compartmentalising into water compartments, with little release directly to atmosphere or compartmentalising to soil/sediment compartments.

 

Any potential exposure to the environment is predicted to result in rapid redistribution to water; due to its low volatility, high water solubility and partitioning values it is indicated that the majority of the substance would eventually partition to water rather than to soil and sediment should it be released to the environment. 

 

H112339 displays no biodegradability in that it achieved 0% biodegradation in a 28-day study closed bottle test, indicating that it is unlikely to achieve a half life of less than 40 or 60 days within fresh water attributed to ready biodegradation alone. In addition, the substance showed no hydrolysis at environmentally relevant pH’s (t1/2 > 1 year at pH7), precluding the potential for significant removal by hydrolysis. . Studies on direct phototransformation in water are not available but it is assumed on the basis of chemical structure and nature of use that the substance is not degraded by direct photolysis. It is concluded, therefore, that abiotic and biotic processes would not contribute significantly to the depletion of the substance within the environment. 

 

H112339 has a measured log Pow of -5.7. This value indicates that possible bioaccumulation in the food chain is not anticipated. A study of bioaccumulation in fish demonstrated that the substance does not have the potential to bioaccumulate, based on a BCF of < 3.3. This compliments the indications from the physico -chemical studies, particularly the fat solubility study (with results of < 0.009 mg in 100 g fat at 37 deg C) indicate that bioaccumulation within body tissues is unlikely. Given the fact that the substance is subject to hydrolysis at biologically relevant pH’s, it is anticipated that bioaccumulation of the substance itself would not occur, as hydrolytic effects in association with metabolic effects would result in removal of the substance.

 

Adsorption to soil is deemed to be low, based on the very low soil adsorption coefficient value and high water solubility. Such a low potential indicates that the substance is unlikely to bind tightly to soils and sediments and instead partition almost exclusively to water. As such, significant exposure related effects to sediment and soil dwelling organisms are considered to be negligible.

 

 Based on its high water solubility, low partition coefficient and it can be concluded that it is unlikely that H112339 could potentially be persistent within the environment. However assessment of the bioaccumulation potential of the substance indicates that the substance is not bioavailable to organisms. As such, significant contact with organisms via the food chain is not anticipated and can be considered to be minimised. 

 

Finally, H112339 demonstrates low acute toxicity in mammalian studies therefore in the event of exposure to environmental organisms, effects due to secondary poisoning can be excluded.

 

Reliability.

The studies have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were all conducted to GLP in compliance with recognised guidelines.

 

Justification for classification or non classification

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).