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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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Name:
Propyl gallate
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Name:
Boundary composition
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Propyl gallate was tested according to OECD 301F to be not readily biodegradable. Based on this available information, the test substance is considered to be vP (and P).

Propyl gallate has a partition coefficient (log Pow) of 1.8 hence lacks any bioaccumulation potential.

Pseudokircheneriella subcapitata were identified as most sensitive organism in the tests for aquatic toxicity with a 72-h ErC50 of 0.37 mg/L. In this test, the chronic effect level (ErC10, 72-h, growth rate) is 0.17 mg/L. Since the EC50 and EC10 are above 0.01 mg/L, the substance is not considered to fulfil the toxicity criterion T. Furthermore, the substance is neither classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A or 1B, or 2), nor is there other evidence of chronic toxicity, as identified by the classifications "STOT RE 1, or STOT RE 2" according to CLP Regulation.

In conclusion, propyl gallate is not readily biodegradable, not bioaccumulating, and does not fulfil any of the T-criteria. Therefore, the substance does not qualify for classification as PBT.