Registration Dossier
Registration Dossier
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EC number: 429-240-8 | CAS number: 212652-59-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistency assessment
In a DOC Die-Away Test over 28 days conducted according to the OECD Guideline for Testing of Chemicals No. 301 A, FAT 40574/B showed biodegradation of 0 % at the end of the test. The test substance was not readily biodegradable under the test conditions within 28 days. In addition, an inherent biodegradability study conducted according to OECD 302B (Modified Zahn-Wellens test) showed that the substance is not inherently biodegradable (2 % within 28 days). Thus, FAT 40574 was considered to fulfil the persistency criteria.
Bioaccumulation assessment
Due to its very good solubility in water but very poor in n-octanol of the test material, the shake-flask method according to OECD Guideline 107 and EU Method A.8, applicable for salts, was used to determine the partition coefficient resulting in a Log Pow of -5 at 20 °C. Thus, the substance is considered not fulfilling the screening criteria for bioaccumulation and no further testing is required.
Toxicity assessment
The LC50/EC50 for FAT 40574 with fish, Daphnia and Algae was found to be greater than 100 mg/L. Also, it was concluded to not have mutagenic or reproductive toxicity potential based on the available studies. The repeated dose toxicity study did not show specific target organ toxicity, too. Thus, it can be concluded to not fulfil the T-criterion.
Conclusion on PBT
FAT 40574 fulfils the persistency criteria, but the bioaccumulation and toxicity criterias are not fulfiled, hence it is considered to be neither PBT nor vPvB.
Reference
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