Registration Dossier
Registration Dossier
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EC number: 249-060-1 | CAS number: 28510-23-8
PBT assessment
Administrative data
PBT assessment: overall result
- 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. Acute toxicity testing towards fish demonstrated no effect of the substance within the range of the water solubility. The substance is not persistent and has a low potential for bioaccumulation. Thus a chronic toxicity of the substance is not expected. Furthermore the substance is not classified for specific target organ toxicity after repeated exposure, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals (See Section 5.9). The criteria for “T” based on mammalian effects are therefore not met. 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.
However, studies on the short-term toxicity to aquatic invertebrates and algae (OECD 202 and 201) and long-term toxicity to daphnia (OECD 211) are ongoing for 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS No. 28510-23-8). The relevance of the existing aquatic toxicity data can only be evaluated, when the results of the ongoing studies are available. The dossier will be updated as soon as possible, and the Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 and the PBT assessment will be re-evaluated based on the outcome of the new studies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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