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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In Annex X of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), it is suggested, that "in the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms.The choice of the appropriate tests depends on the outcome of the chemical safety assessment. In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term. These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely."

Considering its solubility, volatility and resultant Henry’s Law Constant, metformin hydrochlorid is expected, under equilibrium conditions, to exist principally in water.The substance has no industrial release to the compartment soil, has low potential for adsorption (based upon the log Koc), is not bioaccumulative and suggesting little hazardous potential towards soil organisms.Furthermore, results of aquatic tests suggesting little hazardous potential towards soil organisms. Therefore, the equilibrium partitioning method has been used to assess the hazard potential of metformin hydrochlorid for soil organisms.

Exposure assessment shows a RCR < 1 for soil compartment.