Registration Dossier
Registration Dossier
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EC number: 255-901-3 | CAS number: 42594-17-2
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
No experimental toxicokinetic study is available on Triclyclodecane dimethanol diacrylate. However, as per REACH guidance document R7.C, information on absorption, distribution, metabolism and excretion may be deduced from the physicochemical properties and QSAR predictions.
Based on the toxicological data and the physicochemical properties, the absorption of Triclyclodecane dimethanol diacrylate is expected to be 100% by oral route and by inhalation, 10% by dermal route.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 100
Additional information
No experimental toxicokinetic study is available on Triclyclodecane dimethanol diacrylate.
However, as per REACH guidance document R7.C, information on absorption, distribution, metabolism and excretion may be deduced from the physicochemical properties, including:
-Mean molecular weight: 304.4 g/mol
-Water solubility: 9,78 mg/L (20°C)
-Partition coefficient Log Kow: 4,64
-Vapour pressure: 0.0274 Pa (25°C)
ABSORPTION
Oral absorption
The high value of log Kow (>4) and the low solubility (<100 mg/L) of Triclyclodecane dimethanol diacrylate are favorable for a low oral absorption.
Using a model to predict either high or low fraction absorbed for an orally administered, passively transported substance, the rates of absorption of test subtance were 100 and 90% for a dose of 1 and 1000 mg, respectively (Danish QSAR). According to the model "Intestinal absorption (human)" (pkCSM), 97 % of the substance is absorbed after oral exposure.
No clinical effects or mortality were observed after one single administration (2000 mg/kg) of Triclyclodecane dimethanol diacrylate by gavage (oral route) in rats.
For the risk assessment, 100% of oral absorption is taken into account.
Dermal absorption
With a solubility of 9,78 mg/L, dermal absorption is anticipated to be low to moderate. A Log Kow of 4,64 suggests that the rate of penetration of the substance may be limited by the rate of transfer between the stratum corneum and the epidermis. However, a molecular mass smaller than 500 g/mol are favourable to a dermal absorption. The acrylates are known to bind to skin components, and this binding decreases their dermal absorption.
The dermal absorption of the substance is estimated to be low (<= 10%) according to IH SkinPerm (QSAR).
In the dermal acute toxicity study, where no major systemic effect or mortality were observed in rats treated with 2000 mg/kg bw. However, Triclyclodecane dimethanol diacrylate showed allergic reaction in the GPMT: it is evidence that some uptake must have occurred although it may only have been a small fraction of the applied dose.
For the risk assessment, 10% of dermal absorption is taken into account.
Inhalation absorption
Based on the low value of the vapour pressure (<0.1 Pa), Triclyclodecane dimethanol diacrylate is not considered as a volatile substance. Moreover, the absorption by inhalation can be expected to be low for Triclyclodecane dimethanol diacrylatebased on the values of water solubility and log kow.
For the risk assessment, 100% of absorption is taken into account.
DISTRIBUTION
No specific data is available on the distribution of Triclyclodecane dimethanol diacrylate.
According to the QSAR models (pkCSM), the volume of distribution (VD, i.e. theoritical volume that the total dose of a drug would need to be uniformly distributed to give the same concentration as in blood plasma) is moderate, 13.9% of the absorbed dose is unbound in the plasma, and the substance is cross moderately the blood-brain barrier.
No organ toxicity was showed in the repeated toxicity studies.
METABOLISM
No specific data is available on the metabolism of Triclyclodecane dimethanol diacrylate.
ELIMINATION
Due to the low water solubility and the low molecular mass, the excretion of Triclyclodecane dimethanol diacrylate in the urines is expected to be low. An excretion via faeces is possible.
According to the QSAR models (pkCSM), the substance is not a OCT2 substrate : the substance is not transported by this renal transporter.
And the predicted total clearance (hepatic & renal clearance) is low.
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