N-amidinosarcosine

Toxicity to microorganisms

Link to relevant study record(s)

Reference

Endpoint:

activated sludge respiration inhibition testing

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant

Additional information

In accordance with REACH Annex VIII, column 2, the study does not need to be conducted if there are mitigating factors indicating that microbial toxicity is unlikely to occur.

Creatine is a substance that is produced naturally in the body. As cited in the Hazardous Substances Data Bank (HSDB), 60 to 67 % of the creatine entering muscle and nerve cells gets converted to phosphocreatine via the enzyme creatine kinase. Approximately 2 % of creatine is converted to creatinine. Creatinine and creatine are both excreted by the kidneys. All available toxicity tests do not indicate acute toxic effects of the substance at the maximum concentrations tested (up to 880 mg/L in aquatic tests (acute toxicty to Daphnia magna), and at 2000 mg/kg in an acute oral toxicity test in rats). In a test for ready biodegradability (see IUCLID section 5.2.1) according to OECD 301E, the degradation in the toxicity control that contained both sodium benzoate and the test substance, was not indicative of an inhibition of the microbial activity by the test substance at a concentration of 20 mg DOC/L (equivalent to 54.64 mg creatine/L). What is more, at the production site the waste water from manufacture of creatine is readily used as feed for WWTP microorganisms at the production site. The creatine concentration in the WWTP is 15,000 mg/L.