(2R,3S)-butane-2,3-diol

Toxicity to soil microorganisms

Administrative data

Endpoint:

toxicity to soil microorganisms

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
According to REGULATION (EC) No 1907/200, Annex XI, toxicity testing to terrestrial soil microorganisms was waived based on the available data and weight of evidence. Further testing is regarded as scientifically not justified. Based on the information currently available on the substance, the substance is not considered to be a PBT or vPvB. As the substance is ready biodegradable, not assumed to be highly adsorptive to soil (log Kow < 3, no other indications of high adsorption), and of low aquatic toxicity (EC/LC50 > 1 mg/L) the substance was assigned to soil hazard category 1, according to the ITS as described in ECHA Guidance on Information Requirements and CSA, R.7c. Applying EPM to assess the hazard for soil organisms no risks were identified and in conclusion soil toxicity testing is not required. According to the ITS described in ECHA Guidance on Information Requirements and CSA, R.7c, additional testing on soil microbial activity is necessary, where inhibition of sewage sludge microbial activity was observed in REACH Annex VIII testing. No toxic effects on the respiration of microorganisms were observed up to the limit test concentration of 1000 mg/L, and therefore no further testing is required.