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PBT assessment

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PBT assessment: overall result

Reference
Name:
2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS No. 28510-23-8) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

 

Persistence

2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS No. 28510-23-8) is considered to be inherently biodegradable. This assumption is based on a degradation rate ≥ 20% after 28 determined in a study following OECD 301B which is regarded as evidence of inherent, primary biodegradability (as stated in ECHA Guidance on information requirements and chemical safety assessment, Chapter 7b, p 180 ). Further evidence for inherent biodegradation is given by a second study performed according to OECD 301B with an extended incubation time of 85 days. In this test a degradation rate of 60% (CO2 evolution) was determined after 62 - 69 days (74% after 85 days). So after a prolonged lag phase, observed in both tests, the substance was biodegraded. Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

 

Bioaccumulation

The bioaccumulation potential of 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS No. 28510-23-8) is expected to be low. The bioavailability of the substance is presumably low due to the assumed environmental fate. Furthermore the substance is rapidly metabolised and excreted by organisms and thus an accumulation is not expected. This is supported by calculated low BCF/BAF values (BCF: 15.5 L/kg, BAF 16.5 L/kg; Arnot-Gobas estimate, upper trophic). Thus the substance is not considered to be B or vB.

Toxicity

2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS No. 28510-23-8) is considered to be not toxic to aquatic species at or below the limit of water solubility by acute exposure to fish, Daphnia and algae and chronic exposure.  The substance displays no genotoxicity or mutagenic response suggesting also a low tendency towards potential carcinogenic effects. Finally the substance is not toxic by subacute exposure and not reprotoxic. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is currently considered to be not T.