Propane-1,2,3-triyl 3,5,5-trimethylhexanoate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

According to Regulation (EC) No. 1907/2006, a substance must fulfil all three criteria for persistence, bioaccumulation and toxicity to be considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil the criteria for persistence and bioaccumulation stated in part 2 of Annex XIII to be considered vPvB. 

Data for the definitive conclusion on the PBT or vPvB properties according to the criteria set in Regulation (EC) No. 1907/2006, Annex XIII, parts 1 and 2, are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2012) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.

 

Persistence (P) Assessment:

Propane-1,2,3-triyl 3,5,5-trimethylhexanoate (CAS No. 56554-53-1) reached 60% biodegradation after 28 days, however the 10-day window criterion was not fulfilled and the substance cannot be considered as readily biodegradable. Nevertheless, according to the Guidance on information requirements and chemical safety assessment, Chapter R.11 (ECHA, 2012), due to the stringent nature of the ready biodegradability test, if the pass level is reached (60% biodegradation in 28 days), the substance can be considered as not P.

Based on the available information, propane-1,2,3-triyl 3,5,5-trimethylhexanoate does not meet the P or vP criteria.

 

Bioaccumulation (B) Assessment:

According to the Guidance on information requirements and chemical safety assessment, Chapter R7.c (ECHA, 2012), the potential for bioaccumulation can be estimated from the log Kow value of the substance as a screening approach. Generally, at log Kow values > 6 a decrease in BCF values is observed, probably caused by the reduced uptake with the expected increasing molecular size of such substances. Even though experimental data evaluating bioaccumulation for substances with log Kow > 10 (such as propane-1,2,3-triyl 3,5,5-trimethylhexanoate) is not known, these substances are expected to have BCF values < 2000 L/kg (criterion used to consider a substance Bioaccumulative)(Guidance on information requirements and chemical safety assessment, Chapter 11 (ECHA, 2012).

Based on the available information, the substance does not meet the B or vB criteria.

 

Toxicity (T) Assessment:

Propane-1,2,3-triyl 3,5,5-trimethylhexanoate (CAS No. 56554-53-1) is considered to be not toxic. The assessment is based on a chronic toxicity study on Daphnia magna according to OECD 211 determining a NOEC (21 d) of 100% v/v. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals. The criteria for “T” based on mammalian effects are therefore not met.

 

Propane-1,2,3-triyl 3,5,5-trimethylhexanoate (CAS No. 56554-53-1) is considered not to be PBT or vPvB.