Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

The ready biodegradability of the source substance (R/S)-1,3-butanediol was studied in a Modified Sturm Test following OECD 301B. The test substance was degraded to 81% (CO2/ThCO2) after 29 days. The 10-days window was met. The source substance 1,3-butanediol is readily biodegradable according to OECD criteria.  

It is considered appropriate and scientifically justifiable to use the available ready biodegradability data for the source substance to address the ready biodegradability endpoint for the target substance. In this regard, based on the results of a key GLP-compliant study that was conducted according to OECD guideline 301 B / EU Method C.4-C, the target substance can be concluded to be readily biodegradable.  

REACH regulation requires an assessment of the environmental stability characteristics of the substance as part of the environmental stability hazard assessment; further studies can be provided if necessary. A review of the chemical structure of (R)-(-)-butane-1,3-diol shows that it is a glycol, possessing only alcohol functional groups. Since alcohols are generally resistant to hydrolysis, (R)-(-)-butane-1,3-diol is not expected to hydrolyse in water (Lyman, et al., 1990) - (study scientifically not necessary). Investigation into further forms of environmental stability need to be conducted.

 

The biodegradation in water - simulation testing on ultimate degradation in surface water and sediment simulation testing studies do not need to be conducted because the substance is readily biodegradable (study scientifically not necessary). Identification of degradation products does not need to be conducted because the substance is readily biodegradable - [study scientifically not necessary]

 

The biodegradation in soil: simulation testing study does not need to be conducted because the substance is readily biodegradable (study scientifically not necessary). Identification of degradation products does not need to be conducted because the substance is readily biodegradable - [study scientifically not necessary].

 

REACH regulation requires an assessment of the aquatic bioaccumulation characteristics of the substance as part of the environmental bioaccumulation hazard assessment; further studies can be provided if necessary. The aquatic bioaccumulation study does not need to be conducted because the substance has a low potential for bioaccumulation based on log Kow ≤ 3 (study scientifically not necessary). Investigation into further forms of environmental transport or distribution need not be conducted.

 

REACH regulation requires an assessment of the soil adsorption / desorption characteristics of the substance as part of the environmental transport and distribution hazard assessment; further studies can be provided if necessary. The adsorption / desorption: screening study does not need to be conducted because the substance and its relevant degradation products decompose rapidly (study scientifically not necessary). Investigation into further forms of environmental transport or distribution need not be conducted.

Additional information