Registration Dossier
Registration Dossier
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EC number: 946-978-0 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- other: Expert assessment
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An assessment of the toxicokinetics behaviour of the substance was performed using results from existing toxicological studies and its physicochemical profile
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An assessment of the toxicokinetics behaviour of the substance was performed using results from existing toxicological studies and its physicochemical profile
- GLP compliance:
- no
- Type:
- absorption
- Results:
- The substance is not expected to be well-absorbed following exposure via the oral, inhalation and dermal routes, considering its physico-chemical properties and that toxicological studies did not result in any systemic or local effects
- Type:
- distribution
- Results:
- The substance is expected to diffuse across membranes and distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues due to its low-water solubility and lipophilicity.
- Type:
- metabolism
- Results:
- No data is available on the metabolisation of Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate and its two constituents 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate.
- Type:
- excretion
- Results:
- No data investigating the excretion process of the target substance or its two constituents were available. However, owing to its physico-chemical properties. the target substance is expected to be predominantly excreted via faeces
- Details on absorption:
- Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate is a poorly water soluble (0.05 mg/L) and lipophilic substance (Log Kow > 6.5). According to ECHA guidance on specific endpoint R.7c (2017), these properties suggest that absorption of the substance would occur by micellar solubilisation following an exposure via the oral route. However, based on the physicochemical properties of the substance, reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate is expected to be poorly absorbed following an exposure via the oral route. In addition, the substance did not result in any systemic effects up to the limit doses tested in oral toxicology studies in rats, including up to 2000 mg/kg bw in the acute oral toxicity study, and up to 1000 mg/kg bw/day in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening study.
The substance has a vapour pressure of 0.60 hPa at 20°C and a boiling point above 150°C (361 °C), indicating that the substance has a low volatility and may be poorly available for inhalation as a vapour.
As stated above, the substance is poorly soluble in water and lipophilic; according to ECHA guidance on specific endpoint R.7c (2017), for a substance to partition from the stratum corneum into the epidermis, it must have a water solubility above 1 mg/L and a Log Kow < 4. Therefore, considering the physicochemical properties of the substance, penetration across the skin is expected to be low. Furthermore, reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate was not found to be irritant or corrosive to the skin, therefore it is not expected to damage the skin and thus enhance its dermal penetration. Moreover, no sensitisation potential of reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate was observed in a relevant study which only would become apparent when some absorption via the skin is anticipated. - Details on distribution in tissues:
- Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate is a low-soluble water (0.05 mg/L) and lipophilic substance (Log Kow > 6.5). According to ECHA guidance on specific endpoint R.7c (2017), these properties suggest that the substance is likely to diffuse across membranes and distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues. Moreover, lipophilic substances have the potential to accumulate within the body if the dosing interval is shorter than 4 times the whole-body half-life. On this basis, there is the potential for highly lipophilic substances (log P >4) to accumulate in individuals that are frequently exposed (e.g. daily at work) to that substance. Once exposure stops, the concentration within the body will decline at a rate determined by the half-life of the substance.
- Details on excretion:
- No data investigating the excretion process of Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate or its two constituents were available. However, owing to the lipophilic nature of the substance and low water solubility, the substance is expected to be predominantly excreted via faeces.
- Metabolites identified:
- not measured
- Conclusions:
- An assessment of the toxicokinetics behaviour of the target substance was performed using results from existing toxicological studies.
- Executive summary:
An expert review of the toxicokinetic profile of the Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate was assessed based on physicochemical profile and available toxicity data.
The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism, and excretion of the target substance. The target substance is not expected to be well-absorbed following exposure via the oral, inhalation, and dermal routes, considering its low water solubility, Log Kow greater than 6.5, low vapour pressure, and that toxicological studies did not result in any systemic or local effects. Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate is expected to diffuse across membranes and distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues due to its low water solubility and lipophilicity. No data is available on the metabolisation and excretion of Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate and its two constituents 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate. However, the substance is expected to be eliminated predominantly via faeces.
Reference
Description of key information
An expert review of the toxicokinetic profile of the Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate was assessed based on physicochemical profile and available toxicity data.
The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism, and excretion of the target substance. The target substance is not expected to be well-absorbed following exposure via the oral, inhalation, and dermal routes, considering its low water solubility, Log Kow greater than 6.5, low vapour pressure, and that toxicological studies did not result in any systemic or local effects. Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate is expected to diffuse across membranes and distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues due to its low water solubility and lipophilicity. No data is available on the metabolisation and excretion of Reaction mass of 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate and its two constituents 2-dodecylhexadecyl methacrylate and 2-Tetradecyloctadecyl methacrylate. However, the substance is expected to be eliminated predominantly via faeces.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
