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PBT assessment

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PBT assessment: overall result

Reference
Name:
2,2'-(2-methylpropylidene)bis[4,6-xylenol]
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
2,2'-(2-methylpropylidene)bis[4,6-xylenol]
PBT status:
further information relevant for the PBT assessment is necessary
Justification:

The substance fulfils the T and potentially fulfils the P/vP, B/vB criterion. According to the Guidance on Information Requirements and Chemical Safety Assessment Part C: PBT/vPvB assessment Version 3.0 June 2017 - Table C.4-1 the substance could potentially persistent/very persistent based on the results obtained from the QSAR estimation program Biodegradation Probability Program BIOWIN v4.10.

 

The criteria for determining if a substance is potentially P or vP is: Biowin 6 (MITI non-linear model prediction) and Biowin 3 (ultimate biodegradation

time)Does not biodegrade fast (probability <0.5)(a) and ultimate biodegradation timeframe prediction:months (value <2.25 (to 2.75).

Results obtained: 0.0391 - Not Readily Degradable / - 2.2782 - Weeks-Months).

 

The substance log Pow value has been experimentally determined and is 5.6. The criterion for deciding if a substance is potentially B or vB is: Log Kow > 4.5. Therefore under the REACH Regulation, the substance is potentially B or vB.

 

Toxic criterion has been fulfilled from a 28 day Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test

which was in accordance with OECD guideline 422. Due to the NOAEL: 10 mg/kg/day (based on clinical signs and behavioural changes observed in the functional observations tests) the substance has been assigned the classification STOT RE 2, H373 following the criteria from the CLP Regulation 1272/2008.