Registration Dossier
Registration Dossier
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EC number: 701-405-1 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
A CO2 evolution test was used to assess the ready biodegradability in water. The test item attained0% biodegradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301B. Care should be taken in the interpretation of the results due to the inhibitory nature of the test item to the activated sewage sludge micro-organisms used in the study. It should also be noted that the test substance is a UVCB containing multiple carbon chain components and as a consequence current biodegradation tests may not be appropriate.
Although the presence of ester bonds would suggest that the substances may be susceptible to hydrolysis, no degradation was apparent during a ready biodegradability study on BADGE-EDA, thereby suggesting that hydrolysis will not occur. Furthermore, available data on potential hydrolysis products (bisphenol A and the ethylene amines) have shown ready biodegradability providing supporting evidence of no hydrolysis.
The substances BADGE-EDA, BADGE-DETA and BADGE-TETA are considered to be inherently biodegradable.
A reliable (Klimisch 1), GLP experimental partition coefficient study using the HPLC method was conducted for BADGE-EDA according to the OECD Guideline No. 117 which showed log Pow values between 3.9 and 5.4 (95.9% of test item at 5.4), thereby indicating that BADGE-EDA is considered potentially bioaccumulative (B or vB). However, available shake-flask studies for BADGE-DETA and BADGE-TETA showed log Pow values of 0.704 and 0.292 respectively and therefore the substances are not considered potentially bioaccumulative (i.e. not B or vB). A weight of evidence approach has been supplied with the dossier. It is concluded that the LogKow derived using the OECD 117 HPLC method is likely to be an anomalous poor estimate and is not supported by the experimental/in-silico data data presented within the submitted weight of evidence document. It is concluded that the determined LogKow range of 3.9 - 5.4 for BADGE-EDA should not be considered. It is proposed that the experimentally derived LogKow of 1.97 determined for BADGE-TETA is used as a conservative estimate for regulatory purposes.
Reference
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