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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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Name:
Boundary Composition
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
Name:
Legal Entity Composition: Reaction Mass of (4R)-4-isopropenyl-1-methylcyclohexene and (4R)-4-(2-methoxypropan-2-yl)-1-methylcyclohexene
Type of composition:
legal entity composition of the substance
State / form:
liquid
Related composition:
Composition 2
>= 64 - <= 93 % (w/w)
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
This impurity is considered relevant for the classification and labelling of the substance
PBT status:
the substance is not PBT / vPvB
Justification:

The substance does not meet the criteria for PBT or vPvB. Whilst the registrant can not rule out persistence, the substance is not considered bioaccumulative or toxic.

The substance has been tested for biodegradability at the screening level (OECD 301D), with 40 % biodegradation achieved after 28 days and 43 % biodegradation achieved after 60 days. For n-octabol/water partition coefficient, some of the constituents have measured log Pow values >4.5, indicating a potential for bioaccumulation. However, these substance are known not to be bioaccumulative and/or PBT, supported by BCF predictions indicating that all constituents have BCF values significantly <2,000, which are also submitted in this dossier. Therefore the conclusion for the substance is that it is not bioaccumulative in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11. While a full dataset on chronic aquatic toxicity data is not available, the substance is not considered toxic based on consideration of the acute aquatic toxicity data (including results of studies in algae, daphnia and fish per OECD 201, 202, and 203), which do not fulfill the screening criteria for toxicity based on the EC50 values of these studies. Based on the available information, the substance is not classified as having CMR properties, nor does it show other evidence of toxicity criteria based on a sub-acute toxicity study in animals.

In conclusion, the substance is considered neither PBT nor vPvB.