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PBT assessment

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PBT assessment: overall result

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Name:
reaction mass of 2,4,6-trimethyl-4-phenyl-1,3-dioxane isomer 1 and 2,4,6-trimethyl-4-phenyl-1,3-dioxane isomer 2, Composition A
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
Name:
reaction mass of 2,4,6-trimethyl-4-phenyl-1,3-dioxane isomer 1 and 2,4,6-trimethyl-4-phenyl-1,3-dioxane isomer 2, Composition B
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for the test substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).

 

Persistence

The test substance is not readily biodegradable in view of the results of one study conducted according to EU method C.4-E (0% biodegradation after 28 d). Thus, the substance meets the screening criterion for persistency and it is considered to be persistent (P) or very persistent (vP).

 

Bioaccumulation

The test substance has a log Kow of 2.94 - 3.09 (EU Method A.8). Thus, the substance does not meet the screening criterion for bioaccumulation (log Kow ≥ 4.5) and is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

 

Toxicity

A long-term toxicity result for Pseudokirchneriella subcapitata is available with an ErC10 (72 h) of > 43.3 mg/L (nominal). Moreover, the test substance is not classified for toxicity according to the criteria in Annex XIII of Regulation (EC) No 1907/2006 based on Regulation (EC) No 2015/1221 (7th ATP). Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the substance is not considered to meet the T criterion.

 

In conclusion, the test substance is not considered to be PBT or vPvB.