Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Biodegradation

An OECD 301D (Ready Biodegradability: Closed Bottle Test) study was conducted using the test substance Betadet SHR. Results demonstrate that the test substance can be considered to be readily biodegradable, given that the substance attained 94% degradation after 28 days whilst meeting the 10-day window (showing 25% degradation on day 6 and 77% degradation on day 12 of the study).  

 

The reference substance, sodium benzoate, attained 93% degradation after 28 days, thereby confirming the suitability of the test method and culture conditions. Furthermore, the toxicity control, attained 87% degradation after 28 days, confirming that Betadet SHR was not toxic to the sewage treatment microorganisms used in the study. As such, the study is considered to be valid.

Hydrolysis

Studies would suggest that 1-propanamium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-,N-C12-14 acyl derivs., hydroxides, inner salts is readily biodegradable, therefore hydrolysis studies need not be conducted and may be waived on this basis.

Bioaccumulation

In accordance with REACH Annex VIII column 2, the bioaccumulation studies do not need to be conducted if the substance has a low potential for bioaccumulation based on a Log Kow value of <=3. The Log Kow value of the main constituent of 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts (the propanaminium C12 species) was calculated using KOWWIN (v1.68) to be -2.34, indicating low potential for bioaccumulation.

Adsorption/desorption

Studies would suggest that 1-propanamium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-,N-C12-14 acyl derivs., hydroxides, inner salts is readily biodegradable and will therefore decompose rapidly. Therefore adsorption/desorption screening studies need not be conducted and may be waived on this basis.

Additional information