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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
other: expert assessment
Adequacy of study:
key study
Study period:
2018
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

Data source

Reference
Reference Type:
other: Expert assessment
Title:
Unnamed
Year:
2019
Report date:
2018

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
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Propenoic acid, 2-methyl-, tetracosyl ester, branched
EC Number:
292-146-9
EC Name:
2-Propenoic acid, 2-methyl-, tetracosyl ester, branched
Cas Number:
90552-24-2
Molecular formula:
C28H54O2
IUPAC Name:
2-Propenoic acid, 2-methyl-, tetracosyl ester(branched)
Test material form:
liquid

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
Adsorption via the oral is expected and was confirmed by experimental data. Dermal absorption is expected to be slow and limited but was not confirmed by experimental data.
Type:
distribution
Results:
The substance is expected to accumulate in adipose tissues.

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Oral exposure: 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) is a highly hydrophobic and lipophilic substance (Log Kow > 6). These properties suggest that absorption of the substance would occur by micellar solubilisation following an exposure via the oral route. In addition the substance has a molecular weight below 500 Da which favours absorption in the gastrointestinal tract. Two animal studies were conducted via the oral route, one showing a dose-related, statistically significant increase in chloride level in male animals, suggesting that absorption occurred following an oral exposure

Inhalation exposure: 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) has a vapour pressure < 0.75 mmHg at 20°C therefore no exposure via inhalation to the substance as a vapour is expected. There is no data available on the effects of the substance following an inhalation exposure.

Dermal exposure: Since 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) has a molecular mass < 500 Da, it can theoretically be absorbed following a dermal exposure. 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) is poorly soluble in water (<< 1 mg/L) and has a high Log Kow (> 6). 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 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched), penetration across the skin is expected to be limited and very slow. 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) 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. There is no data available on the systemic effects of the substance following a dermal exposure.
Details on distribution in tissues:
2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) is a highly lipophilic substance. Following absorption it can therefore be expected to distribute into cells and to accumulate in adipose tissues. Two animal studies were performed 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched). Some general clinical signs were observed during them, however there were no specific signs of toxicity that would allow to comment on the distribution of the substance in a mammalian body.
Details on excretion:
There is no data available on the elimination of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched).

Metabolite characterisation studies

Metabolites identified:
not measured
Details on metabolites:
There is no data available on the metabolisation of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched).

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:

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-Propenoic acid, 2-methyl-, tetracosyl ester(branched).

However, it can be expected that the substance will be absorbed following an exposure via the oral route, which is supported by results of two animal studies performed on 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) using this route of exposure. No exposure to the substance via inhalation as a vapour is expected. In regards to the dermal route, absorption is expected to be negligible considering the properties of the substance.

Available data on 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) do not allow to assess the distribution, metabolisation and elimination of the substance.