Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 273-868-3 | CAS number: 69103-01-1
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
Description of key information
Two key studies have been used in a weight-of-evidence approach:
In a study carried out according to OECD 301 F and GLP (Kreutzer, 2010), Neobergamate forte biodegraded 44% biodegradation after 28 days and 61% after 60 days.
In a study carried out according to OECD 301 B and GLP (King, 1996), Neobergamate forte biodegraded 59% biodegradation after 28 days.
According to both tests, the substance should be regarded as not readily biodegradable but as inherently biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- inherently biodegradable
Additional information
The ready biodegradability of Neobergamate Forte has been investigated using two standard ready screening methods, the OECD 301F Manometric Respirometry Test (Kreutzer 2010) and a modified OEC301B test in sealed vessels (King 1996). The average level of biodegradation achieved after 28 days was 44% and 59 % respectively. Therefore, Neobergamate Forte cannot be regarded as readily biodegradable.
The slower rate of biodegradation observed in the OECD 301F test compared to the sealed OECD 301B test is likely attributed to the higher test concentration used (100mg/L compared to 10 mg/L).
The result from the modified 301B sealed test of 59% is only just below the pass level criterion of 60%. Such results can be used to prove inherent biodegradability (ECHA Guidance, Chapter R.7b, Version 2.0 - November 2014, p197). This is also the case when the pass level criterion is fulfilled in an extended ready biodegradability test. The OECD 301F test was prolonged beyond 28 days because the curve showed that a plateau had not been reached. The level of degradation achieved after 60 days was 61%. Therefore, Neobergamate Forte should be regarded as inherently biodegradable.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
