Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Stability

According to Table 9.2.2.1 Column 2 of the REACH regulation (1907/2006), a hydrolysis study does not need to be conducted if the substance is readily biodegradable. A reliable ready biodegradability study is available (according to OECD Guideline 301B and EU-method C.4-C) which concluded that ε-Caprolactone, oligometric reaction products with 2,2'-oxydiethanol is readily biodegradable. The hydrolysis data requirement has therefore been waived and further studies are not considered necessary.

Biodegradability

A ready biodegradability study was conducted according to OECD 301B and EU-method C.4-C and in compliance with GLP to investigate the biodegradability of the test item, item ε-Caprolactone, oligometric reaction products with 2,2'-oxydiethanol.

The test item achieved a mean of 90% degradation after 28 days, with a mean of 69% degradation at the end of the 10-day window. Given that the test item is a substance with a complex composition containing different constituents (UVCB) and not a pure substance, the 10-d window consideration may be waived. However, since the test item achieved >60% biodegradation within 28 days and fulfilled the 10 -day window criterion it may be considered to be unambiguously “readily biodegradable within 28 days”.

The test substance, ε-Caprolactone, oligometric reaction products with 2,2'-oxydiethanol is therefore concluded to be readily biodegradable.

Transport and distribution

According to Table 9.3.1 Column 2 of the REACH regulation (1907/2006), an adsorption/desorption screening study does not need to be conducted if, based on the physicochemical properties of the substance, low potential for adsorption is expected (i.e. if the substance has a low octanol-water partition coefficient). Given that the weighted average log Pow value of e-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol is 1.8 (i.e. <3), low adsorption potential is expected and further studies are not considered necessary.

Additional information