Registration Dossier
Registration Dossier
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EC number: 701-362-9 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
No experimental toxicokinetic study is available on Ethoxylated bisphenol A diacrylate. However, as per REACH guidance document R7.C (May 2008), information on absorption, distribution, metabolism and excretion may be deduced from the physicochemical properties.
Based on the toxicological data and the physicochemical properties, absorption of the substance is expected by oral route at the high doses, but a low or no absorption is expected by dermal route and by inhalation.
Key value for chemical safety assessment
Additional information
No experimental toxicokinetic study is available on Ethoxylated bisphenol A diacrylate. However, as per REACH guidance document R7.C (May 2008), information on absorption, distribution, metabolism and excretion may be deduced from the physicochemical properties, including:
-Molecular weight: [424 -556] g/mol for 88% of the reaction products
-Water solubility: 0.425 mg/L (20°C)
-Partition coefficient Log Kow: 3.66 -4.16
-Vapour pressure: 0.335 10^-6 Pa (20°C)
ABSORPTION
The value of log Kow (near to 3 and 4) and the low water solubility are in the range suggestive of low absorption from the gastro-intestinal tract subsequent to oral ingestion. Indeed the absorption of highly lipophilic substances may be limited by the inability of such substances to dissolve into GI fluids
This assumption of a low oral absorption is confirmed in the acute toxicity study: no systemic effect or mortality was observed in rats treated at 2000 mg/kg bw. However clinical signs and a minimal liver toxicity were observed in the repeated toxicity study at the highest dose (1000 mg/kg/day). Indeed, Ethoxylated bisphenol A diacrylate seems to be absorption by oral route at the high doses.
With low water solubility, a high value of log Kow and a molecular mass near to 500 g/mol, dermal absorption is anticipated to be low. Moreover, the acrylates are known to bind to skin components, and this binding decreases their dermal absorption. This assumption of a low dermal absorption is confirmed in the dermal acute toxicity study, where no systemic effect or mortality was observed in rats treated at 2000 mg/kg bw. Moreover, Ethoxylated bisphenol A diacrylate showed no allergic reaction in the LLNA.
Based on the molecular mass near to 500 and a log Kow near to 3 -4, a dermal absorption can be estimated to be 50%.
Based on the very low value of the vapour pressure, Ethoxylated bisphenol A diacrylate is not a volatile substance. With the low water solubility, no absorption by inhalation is expected for this substance.
DISTRIBUTION and METABOLISM
The molecule is lipophilic (log Kow near to 3 and 4), it is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues. This assumption is confirmed by the changes shown in the repeated dose toxicity studies following oral application: increase of blood cholesterol levels at 1000 mg/kg/day, which were observed in presence of non-adverse increase of mean liver weight and liver microscopic findings (hepatocellular hypertrophy).
No specific data is available on the metabolism of Ethoxylated bisphenol A diacrylate.
ELIMINATION
Due to the low water solubility and a moderate molecular mass (between 200 and 1000 g/mol), the excretion of Ethoxylated bisphenol A diacrylate in the urines is not expected. An excretion via bile and faeces is possible.
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