Registration Dossier
Registration Dossier
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EC number: 256-032-2 | CAS number: 42978-66-5
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
No studies are available in which the toxicokinetic properties of the test substance were investigated.
Based on the physico-chemical properties of the substance and available experimental study findings an absorption via the oral, dermal and inhalation exposure route is likely. The test substance may distribute into cells and the intracellular concentration may be higher than extracellular concentration. Metabolism in the liver will consist of ester hydrolysis or acrylic group conjugation with glutathione. The substance may be excreted in the urine taking into consideration the water solubility, molecular weight and Phase II biotransformation. No bioaccumulation potential can be derived based on the available information.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
There were no studies available in which the toxicokinetic properties of the test substance were investigated. Therefore, the following toxicokinetic statement is based on the physico-chemical characteristics of the substance.
The test substance has a molecular weight of 300.35 g/mol and is a liquid with a water solubility of 4 g/l at 25 °C which can be categorized as moderate to high according to ECHA guidance (Chapter R.7c, 2017). Further, it has a low volatility of 0.000044 hPa at 20 °C and a log Po/w of > 2.5 < 2.7 at 23 °C.
Absorption:
As the substance is a liquid and substances in solution are taken up more readily than dry particulates absorption is favored. Moreover, the molecular weight below 500 g/mol as well as the log Po/w of 2 at 25°C favours absorption either across the epidermis, respiratory tract epithelium or GI tract after passive diffusion following dermal, inhalation or oral exposure. This assumption is supported by the available acute toxicity data indicating systemic toxic effects in the animals after oral uptake (studies performed 1980, 1982,1984) as well as dermal uptake (study performed 1980). The default value for skin absorption can be assumed to be 100% based on the substances physico-chemical properties (ECHA guidance, Chapter R.7c, 2017). As the substance caused sensitization reactions after dermal application, bioavailability of the test material via the dermal route is confirmed. No deaths were seen in an inhalation hazard test when rats were exposed to the volatile components of the tested material for 7 hours (1982). Due to the low vapour pressure of the test substance this result cannot be used to exclude absorption after inhalation. Especially, considering the observation of clinical signs of toxicity after ingestion, absorption after inhalation is also likely.
Distribution:
Based on the log Po/w > 2.5 < 2.7 it is likely that TPGDA distributes into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues. Diffusion is likely to be present through aqueous channels and pores.
Metabolism:
Considering the chemical structure of TPGDA, liver metabolism will consist of ester hydrolysis, leading to release of acrylic acid and tripropylene glycol. In blood, e.g., after dermal uptake, ester hydrolysis plays only a very minor role. Instead, the acrylic group is rapidly conjugated with glutathione (Miller et al. (1981); McCarthy et al. (1994)). Available studies on genotoxicity in-vivo (mouse micronucleus assay) were negative, i.e. there is no indication of a reactivity of tripropylene glycol diacrylate or its metabolites under the test conditions.
Excretion:
The substance may be excreted in the urine taking into consideration the water solubility, molecular weight and Phase II biotransformation.
Accumulation:
Considering the log Po/w, the water solubility and the metabolism, accumulation of the substance is considered to be unlikely.
References
European Chemicals Agency, ECHA guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. DOI:10.2823/43472.Version 3.0. June 2017
Miller, Ayres, Rampy, McKenna (1981). Metabolism of acrylate ester in rat tissue homogenates. Fundamental and applied toxicology 1:410 -414
McCarthy, Hayes, Schwartz, Witz (1994). The reactivity of selected acrylate ester toward glutathione and deoxyribonucleosides in vitro: Structure-activity relationships.Fundamental and applied toxicology 22, 543 -548
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