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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence: Based on a reliable study to determine the ready biodegradability for the test substance, it was concluded that e-Caprolactone, oligomeric reaction products with 2,2’-oxydiethanol is readily biodegradable with >90% degradation in 28 days. The substance is not P or vP.

Bioaccumulation: The weighted average Log Pow value of e-Caprolactone, oligomeric reaction products with 2,2’-oxydiethanol is 1.8 indicating the potential for bioaccumulation is low. In addition, the test substance is readily and rapidly biodegradable indicating the potential to remain in water and accumulate through aquatic food chains is low.The substance is not B or vB.

Toxicity: There are three reliable (Klimisch 1 and 2) studies available for three trophic levels; fish, aquatic invertebrates and algae. The lowest short-term toxicity EC/LC50 was determined to be 33.14 and 6.29 mg/l to aquatic algae, based on geometric mean measured concentrations of the two measured components of the test substance and these do not meet the T criterion.

One long-term endpoint is available from the algal study, but the EC10 values are not biologically relevant for adverse effects on algal growth with a mean inhibition of growth at 4.7% due to the low substance stability in the test medium. The substance is rapidly biodegradable (meets the 10-day window) and not considered to pose a long-term hazard to aquatic organisms. The acute toxicity data for the three trophic levels of organism are relied upon for the PBT assessment of the test substance. Also, based on the available toxicological information available, the substance does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008. The substance does not meet the criteria for classification as specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008. Therefore, the substance is not T.

The overall conclusion is that the test substance, e-Caprolactone, oligomeric reaction products with 2,2’-oxydiethanol is not PBT or vP/vB.