Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

The ready biodegradability of „creatine monohydrate“ was determined according to OECD Guideline 301 E at a nominal concentration of 20 mg DOC/L. Creatine monohydrate degraded by 71.2 % after 10 days of incubation at 21 ± 0.4 °C fulfilling the “10-d window” criterion. Therefore, creatine monohydrate can be classified as"readily biodegradable". This result is used for the classification of creatine (CAS 57 -00 -1) in a read-across approach.

Further biodegradation studies do not have to be conducted:

In accordance with Column 2 adaptation statement of REACH Annex IX, simulation testing on ultimate degradation in surface water (information requirement 9.2.1.2), soil simulation testing (information requirement 9.2.1.3), as well as sediment simulation testing (information requirement 9.2.1.4), do not need to be conducted as the substance is readily biodegradable (CSR section 4.1.2.1.2 Biodegradation in water: screening test). Besides, the test substance entering the water is not likely to sorb onto suspended solids and sediment, and does not have a high potential for adsorption to soil, based upon the measured log Kow. Justification for read-across: For the aquatic REACH endpoint 9.2.1.1 ”Ready biodegradability” the results obtained with creatine monohydrate can be used for the registration of creatine: When dissolved in water there is no chemical difference between “creatine monohydrate” and “creatine”. The crystal water contained in creatine monohydrate does not for the toxicity profile of the substance. Besides, the measurements and results of this ready biodegradability study are not based on mg substance/L, but on mg DOC/L, which is the same for “creatine monohydrate” and “creatine” (both substances have the same carbon content). Therefore, the results obtained for “creatine monohydrate” can directly be used in the REACH substance registration for “creatine”. Therefore, “creatine” can be classified as readily biodegradable.