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Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Dipentaerythritol hexa-3,5,5-trimethylhexanoate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Dipentaerythritol hexa-3,5,5-trimethylhexanoate
Reference substance:
Dipentaerythritol hexa-3,5,5-trimethylhexanoate
Reference substance:
Dipentaerythritol hexa-3,5,5-trimethylhexanoate
Reference substance:
Dipentaerythritol hexa-3,5,5-trimethylhexanoate
Reference substance:
Dipentaerythritol hexa-3,5,5-trimethylhexanoate
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

Not P or vP

A substance-specific study is not available. However, experimental investigation has shown close structural analogues to be readily biodegradable and it is therefore considered unlikely that the registered substance will persist in the environment.

Bioaccumulation

Not B or vB

The substance has an estimated BCF of 0.50 L/kg w/w so has a low potential for bioaccumulation. Furthermore, Log Kow has been determined to be > 10.0 and, in accordance with ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 2.0; November 2014), a decreasing relationship between BCF and Log Kow is observed at very high Log Kow (> 6), The aquatic BCF of the substance is consequently expected to be lower than the threshold value of 2000 for bioaccumulation.

Toxicity

Not T

Based on available evidence, and in accordance with Regulation EC No 12/72/2008, analogues of the substance do not meet the criteria for classification as a carcinogen (category 1A or 1B) or germ cell mutagen (category 1A, 1B or 2). No effects relevant to humans were reported in 28-day repeated dose toxicity studies on analogues of the registered substance, classification for specific target organ toxicity (STOT RE 1 or STOT RE 2) is not required and further (90-day) investigation is not applicable because the substance and its analogues are of low toxicological activity. With respect to the environment,results involving readily biodegradable analogues are available from three trophic levels (fish, Daphnia and algae) and do not lead to acute or chronic classification.

Likely routes of exposure:

- Human exposure via the dermal route

- Environmental exposure via water (direct and indirect) and soil (indirect)