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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification relevant information

Biodegradation

Readily biodegradable based on:

- Read-across from Isomaltulose (CAS 13718-94-0): 90% in 28 d (CO2 evolution, OECD 301 B)

- QSAR prediction for both components of Isomalt, i.e. 1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-glucitol (=6-O-α-D-glucopyranosyl-D-sorbitol) (1,6-GPS)

 

Bioaccumulation

log Kow= -4.2 to -3.7 (HPLC method)

 

Aquatic acute toxicity

Fish

LC50 (96 h) = 13765 mg/L (QSAR prediction for both components of Isomalt, i.e.1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-glucitol (=6-O-α-D-glucopyranosyl-D-sorbitol) (1,6-GPS))

 

Aquatic invertebrates

EC50 (48 h) > 100 mg/L (nominal, OECD 202; read-across from Isomaltulose (CAS 13718-94-0))

 

Aquatic algae

EC50 (96 h) = 34200 g/L (QSAR prediction for both components of Isomalt, i.e.1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-glucitol (=6-O-α-D-glucopyranosyl-D-sorbitol) (1,6-GPS))

 

Aquatic chronic toxicity

Fish

ChV (30 d) = 1.41E8 mg/L (QSAR prediction for both components of Isomalt, i.e.1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-glucitol (=6-O-α-D-glucopyranosyl-D-sorbitol) (1,6-GPS))

 

Aquatic invertebrates

ChV (16 d) = 1.2E7 mg/L ChV (16 d) = 1.2E7 mg/L (QSAR prediction for both components of Isomalt, i.e.1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-glucitol (=6-O-α-D-glucopyranosyl-D-sorbitol) (1,6-GPS))

 

Aquatic algae

ChV (chronic value) (96 h) = 1770 g/L (QSAR prediction for both components of Isomalt, i.e.1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-glucitol (=6-O-α-D-glucopyranosyl-D-sorbitol) (1,6-GPS))

 

Conclusion on CLP

Based on the data above the substance is considered to be rapidly degradable and has a low potential for bioaccumulation based on low log Kow. Moreover, no effects on aquatic organisms were identified. Thus, the substance does not need to be classified according to the consolidated version of Regulation (EC) No 1272/2008 including further amendments (ATPs).