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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
other: Expert assessment
Adequacy of study:
key study
Study period:
2020
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

Data source

Reference
Reference Type:
other: Expert assessment
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Objective of study:
toxicokinetics
Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butoxyethyl methacrylate
EC Number:
236-885-7
EC Name:
2-butoxyethyl methacrylate
Cas Number:
13532-94-0
Molecular formula:
C10H18O3
IUPAC Name:
2-butoxyethyl 2-methylprop-2-enoate
Test material form:
liquid

Results and discussion

Main ADME resultsopen allclose all
Type:
excretion
Results:
No data investigating the excretion of 2-butoxyethyl methacrylate were identified.
Excretion via urine is very likely due to its low molecular weight (< 300 g/mol) and water solubility.
Type:
metabolism
Results:
No data investigating the metabolisation of 2-butoxyethyl methacrylate were found.
Small quantities of methacrylates may readily be metabolized by saponification into methacrylic acid and alcohol.
Type:
distribution
Results:
2-butoxyethyl methacrylate is a hydrophilic substance with a low molecular weight, therefore, it is expected to be well-distributed in a mammalian body through the water compartments but is not expected to accumulate in tissues
Type:
absorption
Results:
Adsorption via the oral route is expected and was confirmed by experimental data. Dermal absorption through skin is likely to occur. However, its penetration into the skin is expected to be limited. No absorption via inhalation is expected

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Oral exposure: 2-butoxyethyl methacrylate is an organic substance with a low molecular weight (186.25 g/mol) and moderate solubility in water (395.7 mg/L). It can be expected that 2-butoxyethyl methacrylate is absorbed passively through GI epithelial tissue.
A Log Kow of 2.47 was predicted for 2-butoxyethyl methacrylate using a QSAR model. This value is between -1 and 4 and therefore supports the fact that the substance is likely to be absorbed by passive diffusion following oral exposure.
An acute toxicity study was performed on 2-butoxyethyl methacrylate via the oral route. At necropsy, signs of systemic toxicity were observed indicating that the substance has been absorbed.

Inhalation exposure: 2-butoxyethyl methacrylate has a vapour pressure of <0.99 hPa=0.099 kPa and a boiling point of 228°C at 101.325 kPa. According to ECHA (2017), only highly volatile substances (with vapour pressure greater than 25 kPa and boiling point of <50°C) may be available for respiratory absorption. Therefore, no exposure via inhalation to this substance is expected.
There is no data available investigating the toxicokinetic behaviour of the substance following an inhalation exposure.
There is no data available on the effects of the substance following an inhalation exposure.

Dermal exposure: The substance has a molecular mass of 186.25 so it could theoretically be absorbed following dermal exposure (Bos et al., 2000). However, its dermal penetration would be limited by its molecular mass being above 100 Da (ECHA, 2017).
According to ECHA (2017), the acrylate group may decrease the uptake of the substance due to binding to skin components.
Water solubility of the 2-butoxyethyl methacrylate (395.7 mg/L) is in the range of 100-1,000 mg/L which indicates a moderate to high absorption through skin.
The 2-butoxyethylmethacrylate is irritant to skin, therefore, irritation may increase the dermal absorption of this substance.
Considering the physicochemical properties of the 2-butoxyethyl methacrylate, absorption through skin is likely to occur. However, its penetration into the skin is expected to be limited because stratum corneum has a lipophilic nature that resists penetration of hydrophilic compounds. There is no data available on the systemic effects of the substance following a dermal exposure.
Details on distribution in tissues:
Since 2-butoxyethyl methacrylate is a hydrophilic substance with a low molecular weight, it is expected to be well-distributed in a mammalian body through the water compartments but is not expected to accumulate in tissues (ECHA, 2017).
An acute toxicity study performed on the substance showed mottled lungs and discoloured liver, indicating exposure of these organs to the substance
Details on excretion:
No data investigating the excretion of 2-butoxyethyl methacrylate were identified.
Excretion via urine is very likely due to its low molecular weight (< 300 g/mol) and water solubility.

Metabolite characterisation studies

Metabolites identified:
not measured
Details on metabolites:
No data investigating the metabolisation of 2-butoxyethyl methacrylate were found.
Small quantities of methacrylates may readily be metabolized by saponification into methacrylic acid and alcohol. Methacrylic acid forms an acetyl-coenzyme A derivative which then enters the normal lipid metabolism (Clayton and Clayton, 1981-1982).

Applicant's summary and conclusion

Conclusions:
An assessment of the toxicokinetics behaviour of the substance was performed using results from
existing toxicological studies.
Executive summary:

An expert review of the toxicokinetic profile of the test substance was assessed based on physicochemical profile and availabel 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, metabolisation and excretion of 2-Butoxyethyl methacrylate.


However, it can be expected that the substance will be absorbed following an exposure via the oral route, which is supported by a result on an animal study performed on the substance using this route of exposure. No exposure to the substance via inhalation as a vapour is expected. In regards to the
dermal route, partition coefficient and water solubility of 2-butoxyethyl methacrylate (395.7 mg/L) indicates a moderate to high absorption through skin.


Absorbed test substance is expected to be excreted via the kidneys into the urine due to its low molecular weight (< 300 g/mol) and water solubility.


There is no expectation that the test substance will preferentially distribute to particular organs or tissues in the body. 2-butoxyethyl methacrylate is expected to be well-distributed in the human body due to its low molecular weight and high-water solubility but it is not expected to accumulate. Available animal data on the substance do not provide evidence to support this prediction.