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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:

Summary and conclusions on persistence

 

Based on biodegradation test data, this substance is not expected to be readily biodegradable. It is very likely that the limited solubility in water would have impaired the rate of biodegradation noted in the ready biodegradation test, but this alone would not account for the low level of response. It must also be noted that easy biological degradation is not desirable in this class of substance as microbial breakdown of lubricants is considered detrimental to their function.This substance fulfills the screening criterion for persistence and is identified as being potentially persistent.

 

Summary and conclusions on bioaccumulation

 

Based on the measured Log Kow data (10.5), large molecular weight (average > 1600 g/mol) and low order of toxicity observed in subchronic animal testing from the similar materials that make up the Epoxidized Oils and Derivatives Chemical Category (SIDS, 2006), this substance is expected to have low bioaccumulation potential. This substance does not meet the criteria of concern for bioaccumulation.

 

Summary and conclusions on toxicity

Based on the available acute and chronic toxicity data in algae, daphnids, and fish, this substance is considered unlikely to have significant effects on aquatic organisms in short and long term scenarios and data demonstrate that this material does not meet the criterion for toxicity as outlined in ANNEX XIII of Regulation (EC) 1907/2006.

Likely routes of exposure:

Dermal route: is considered a principal route for occupational exposure.

Inhalation route:the test material has an extremely low vapour pressure (too viscous to measure analytically), OECD has indicated that inhalation exposure is negligible if the vapour pressure is less than 1 Pa and ECHA guidance places chemicals with less than 0.1 Pa vapour pressure in the low volatility band (OECD 2003; ECHA R15.5). Therefore, under normal use and handling conditions, respiratory absorption of the test material in the form of vapours, gases, or mists is not expected to be relevant or significant.

Oral exposure: oral is not an anticipated route of exposure to workers or the general population.