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PBT assessment

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PBT assessment: overall result

Reference
Name:
Butyl benzoate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

An evaluation of the inherent properties of butyl benzoate is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2014) were applied.

 

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in a guideline study on ready biodegradability following the OECD 301B (IES, 2018). A 28-d ready biodegradability test (OECD 301F) using unadapted activated sludge from a predominantly domestic waste water treatment plant indicated that butyl benzoate was readily biodegradable under the conditions of the test (initial concentration 100 mg/L). The test substance showed 74% biodegradation (test bottle 1 and 2, respectively, based on % ThCO2). It can therefore be concluded that based on the criteria mentioned above the substance is not persistent in the environment. The substance is concluded to be not P/vP.

 

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation.The available evidence on the bioaccumulation potential for the substance indicates that the screening criteria for bioaccumulation potential (B and vB) are not met. Based on a log Pow of 3.30 at neutral pH, a low BCF can be estimated. Since the log Pow of the substance is < 4.5, the screening criteria for bioaccumulation are not fulfilled and the substance is concluded not to have a bioaccumulative potential (not B / not vB).

 

The toxicity assessment is based on the screening criteria in Annex XIII of the REACH Regulation. Based on an OECD 201 study (Envigo, 2018) it is concluded that the test item does not meet the Toxic (T) criteria since the EC10 was 1.5 mg/L. The test substance is not classified as carcinogenic (Cat. 1 or 2), as mutagenic (Cat. 1 or 2), or as reproductive toxicant (Cat. 1, 2, or 3), nor as STOT RE Cat. 1 or 2 according to the Regulation EC N° 1272/2008. Hence, it does not fulfill the criteria to be considered as Toxic (not T).

 

Taking into account the conclusions that the substance is not P/vP, not B/vB and not T, the substance should not be considered as a PBT/vPvB substance.