Registration Dossier
Registration Dossier
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EC number: 606-441-0 | CAS number: 201305-16-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Benzoic acid, 4-hydroxy-, C18-22-alkyl esters (CAS No. 201305-16-0) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).
Persistence
Not readily biodegradable: 34% (O2 consumption) in 28 days
One study according to ISO 10708 resulted in 34% (O2 consumption) biodegradation after 28 days. Thus, persistency in the environment (P and vP) cannot be excluded.
Bioaccumulation
An evaluation of the bioaccumulation potential of Benzoic acid, 4-hydroxy-, C18-22-alkyl esters is presented in chapter 5.3 indicating that bioaccumulation is expected to be low. According to the Guidance on information requirements and chemical safety assessment, Chapter R.11 (ECHA, 2012), For substances with a log Kow value > 10 it is unlikely that they reach the pass level of being bioaccumulative according to the PBT assessment criteria (BCF > 2000 L/kg). This assumption is supported by QSAR calculations using BCFBAF v3.01 performed for benzoic acid, 4-hydroxy-, C18-22-alkyl esters, resulting in BCF/BAF values of 0.98-1.38 L/kg and 16.2-27.1 L/kg (Arnot-Gobas estimate, including biotransformation, upper trophic). Based on the above information, the test substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.
Toxicity
The L(E)50 values reported in the test conducted with aquatic invertebrates is higher than 0.01 mg/L, and the substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC. Therefore, based on the available information, the test substance does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.
In conclusion, Benzoic acid, 4-hydroxy-, C18-22-alkyl esters is considered not to be PBT or vPvB.
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