Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

PBT assessment

PBT assessment: overall result

Reference

Name:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Type of composition:

legal entity composition of the substance

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Reference substance:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

PBT status:

the substance is not PBT / vPvB

Justification:

Persistence

The test item attained 62% biodegradation at 28 days. Under the strict terms and conditions of OECD Guideline No. 301B the test item cannot be considered to be readily biodegradable as the test item failed to satisfy the 10-Day window validation criterion, whereby 60% biodegradation must be attained within 10 days of the biodegradation exceeding 10%. 

 

According to the CLP criteria if a substance is identified as a UVCB substance or as a complex, multi- constituent substance with structurally similar constituents and where there is sufficient justification, the 10-day window condition may be waived and the pass level applied at 28 days. (CLP Annex 1- 4.1.2.9.5)

 

Test item H-32 is considered as a UVCB substance where all components are structurally similar and study data confirms H-32 did achieve greater than 60% biodegradation within the 28-day time period. On this basis H-32 can be considered as readily biodegradable.

 

Further evidence to support biodegradation is predictions using the BIOWIN models

1, 2, 3, 5 and 6. According to the Biowin helpfile, the criteria for an overall YES or NO prediction are as follows: If Biowin 3 (ultimate survey model) result is “weeks” or faster (e.g. days or days to weeks) AND Biowin5 (MITI linear model) is readily biodegradable, then the prediction is YES(readily biodegradable). (Chapter R-7b endpoint specific guidance)

 

For test item H-32, the result under Biowin model 3 is “days-weeks” and the result under Biowin 5 is readily biodegradable. Results are attached in section 13 of the dossier.

 

Based on all available data listed above biodegradation is confirmed and it may be concluded that the substance does not possess P or vP properties

 

Bioaccumulation

Experimentally derived Log Kow was found to be 6.5 therefore on the basis of the screening criteria it must be considered that the substance could possess B or vB properties, although no data are currently available to confirm this conclusion.

 

Toxicity

The substance is also considered non toxic as none of the available data indicates toxic properties. For mutagenic effects all three in-vitro genetic toxicity studies (Mouse lymphoma assay, Chromosome Aberration and Ames) were all concluded with a negative result therefore indicating that the substance in unlikely to cause mutagenic activity in the absence or presence of metabolic activity.

 

There are no carcinogencity data available however in the absence of genetic toxicity as noted above it is considered that there is no concern for carcinogenic effects..

 

In the reproductive toxicity screening study no reproductive effects were seen and no development effects were seen in the absence of possible toxic effects seen in maternal animals. Also no toxicity was seen in the 28 day repeated dose oral toxicity study.

 

Based on the available information there is no indication of P or T properties therefore the substance cannot be considered a PBT substance.