Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic, n-decanoic, n-heptanoic, and n-octanoic acids

PBT assessment

PBT assessment: overall result

Reference

Name:

Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid

Reference substance:

Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid

Reference substance:

Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid

Reference substance:

Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid

Reference substance:

Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid

Reference substance:

Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid

Reference substance:

Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid

PBT status:

the substance is not PBT / vPvB

Justification:

Assessment of PBT / vPvB properties has been conducted in accordance with the guidance provided in Annex XIII of Regulation 1907/2006 (as amended by Commission Regulation No 253-2011 of 15 March 2011). The substance is not considered to be a PBT or a vPvB substance.

 

Persistence

The available data from the read across substances suggest ready biodegradability of the substance. The ready biodegradability of the read across substances was conducted in accordance with OECD test guideline 301B and EU-Method C.4-C.The result of the studies showed that the overall degradation in 28 days was between 78-96% (CO2 evolution), and thus was concluded that the substance is Readily biodegradable and as such does not meet the criterion for Persistant/very Persistant.

 

Bioaccumulation

Based on the available information from the read across substances, the substance is expected to have a high Kow value (> 8 at 20°C). In accordance with the screening criteria for bioaccumulation in the ECHA Guidance (Chapter R.11 PBT Assessment) the substance would screen as a potential bioaccumulative substance. The likely reliability of the log Kow is however, considered to diminish above a value of 6, as noted in Appendix R.11-1 Annex 1 of ECHA guidance on PBT assessment. Substances with log Kow between 4.5 and 6 are considered likely to be highly accumulating; however no substantial bioconcentration is assumed having a log Kow value greater than 6. For compounds having a log Kow greater than 6, a gradual decrease of BCF is observed and it has been hypothesised within the published literature that a high log Kow is more an effect of solubility than a tendency of the substance to be lipophilic.

This was coincided with the data from peer reviewed publications, articles and read across substances; where the BCF value was indicative of low bioaccumulation potential (BCF < 500).

On the basis of the available information the substance is not considered to be bioaccumulative.

 

Toxicity

The substance is not considered to be toxic above the limit of solubility on the basis of the available ecotoxicity studies available from read across substances. All L(E)C50 data are determined to be in excess of water solubility. No toxicity to aquatic species was observed at or below the water solubility of the substance.

The available data determine that the substance is not mutagenic or clastogenic and is not classified as a reproductive toxin. No carcinogenicity studies have been conducted, however there is no evidence from the available information to suggest that the substance would be carcinogenic.

The repeat dose toxicity studies available from the read across substances the substance is not expected to induce chronic toxicity.

The substance is therefore not classified as carcinogenic, mutagenic, toxic to reproduction, cause chronic toxicity or specific target organ toxicity following repeated or prolonged exposure. The substance does therefore not meet the toxicity criterion.

Conclusions

In conclusion Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid, isononanoic acid, and octanoic acid CAS 118685-22-6 is not considered to be a PBT or vPvB substance.