4-O-α-D-glucopyranosyl-D-glucitol

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

Maltitol

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Maltitol

Reference 2

Name:

Maltitol

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Maltitol

PBT status:

the substance is not PBT / vPvB

Justification:

The substance maltitol is readily biodegradable in OECD 301 test, so it is not considered as persistent or very persistent . Due to its hydrophilic properties, maltitol shows a low log Kow and it is not suspected to be bioaccumulable or very bioaccumulable. The maltitol shows no adverse effect to fish, daphnia and algae with LC0/NOEC ≥ 1020 mg/L (active ingredient measured concentration) in acute tests. So it is not considered as toxic to aquatic organisms. Since no data are available to evaluate the reproduction toxicity, the carcinogenicity and the chronic toxicity, hence no classification is determined. Based on the available genotoxicity data, the substance should not be classified for mutagenicity according to CLP. In conclusion Maltitol is not toxic. Maltitol is not P/vP, not B/vB and not toxic. So maltitol is neither PBT, nor vPvB

Likely routes of exposure:

Due to its low vapour pressure and high water solubility, the aquatic compartment will be the target compartment. However since Maltitol is readily biodegradable it will be biodegraded in sewage treatment plant before it is released into the environment. Moreover due to its low log Kow, this substance is not suspected of bioaccumulation into organisms of the environment.