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Toxicity to soil microorganisms

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toxicity to soil microorganisms
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely

Description of key information

According to ECHA guidance Chapter R.7c: Endpoint specific guidance, Version 3.0 – June 2017, Section R.7.11.2 the following applies: QUOTE: "In the case of readily biodegradable substances which are not directly applied to soil it is generally assumed that the substance will not enter the terrestrial environment and as such there is no need for testing of soil organisms is required." UNQUOTE.

The substance (R)-(-)-butane-1,3-diol was shown to be readily biodegradable, is fully miscible in water and does have a negative log Pow (-0.9). Finally, no direct application to soil is known and indirect exposure of soil is also unlikely. The substance is used as intermediate and monomer in industrial processes, making exposure to soil very unlikely. The professional and consumer uses in cosmetic, washing and cleaning and pharmaceutical products do result in aqueous emissions to sewage treatment plants, in which due to the ready biodegradability the substance would be entirely biodegraded and thus, exposure to soil through these uses of the substance is unlikely too. Thus, long-term exposure to soil is not of concern and no testing for long-term toxicity to soil microorganisms is required, based on exposure considerations.

Key value for chemical safety assessment

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