Hexadecyl methacrylate

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

other: Thesis

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 428 (Skin Absorption: In Vitro Method)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Lauryl methacrylate

IUPAC Name:

Lauryl methacrylate

Constituent 2

Reference substance name:

2-Propenoic acid, 2-methyl-, C12-16-alkyl esters

EC Number:

292-094-7

EC Name:

2-Propenoic acid, 2-methyl-, C12-16-alkyl esters

Cas Number:

90551-76-1

IUPAC Name:

90551-76-1

Constituent 3

Reference substance name:

Dodecyl methacrylate, CAS 142-90-5

IUPAC Name:

Dodecyl methacrylate, CAS 142-90-5

Details on test material:

- Name of test material (as cited in study report): Lauryl methacrylate
Supplier: Röhm GmbH
- Lot/batch No.: 780803361
Physical state: liquid

Radiolabelling:

no

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Duration of exposure:

48 hrs

Doses:

100 µl / cm²

Details on study design:

The absorption of Lauryl methacrylate was evaluated through rat epidermis and intact skin in an in vitro system. Values for human skin absorption
were extrapolated on the basis of a 14 times more efficient permeation through rat skin obtained in an epidermal PBPK model developed in this study.

Results and discussion

Signs and symptoms of toxicity:

not examined

Dermal irritation:

not examined

Absorption in different matrices:

Absorption of Lauryl methacrylate through rat epidermis:

The substance is readily absorbed through rat epidermis at a constant mean rate of 26.2 µg cm-2 hr-1.
This rate of absorption is virtually constant over the duration of the experiment.
The total amount of chemical that was absorbed during the time of exposure was 0.7 % of the applied dose.

Absorption of Lauryl methacrylate through whole rat skin:

Like the smaller esters investigated, Lauryl methacrylate was also metabolised to methacrylic acid as it was absorbed through whole rat skin. The peak rate of appearance of methacrylic acid was calculated to be 11.8 µg cm-2 hr-1, which occurred between 8 and 24 hours.
0.264 % of the Lauryl methacrylate was depleted from the donor reservoir over the 24 hr exposure period.

Percutaneous absorption

Percutaneous absorption 1

Dose:

100 µl/cm²

Parameter:

percentage

Absorption:

0.7 %

Remarks on result:

other: 24 hrs

Remarks:

Rat epidermis

Percutaneous absorption 2

Parameter:

percentage

Absorption:

0.264 %

Remarks on result:

other: 24 hrs

Remarks:

whole rat skin

Conversion factor human vs. animal skin:

With respect to human skin, 14 times more efficient permeation through rat skin obtained in an epidermal PBPK model developed in this study.

Applicant's summary and conclusion

Conclusions:

Lauryl methacrylate is absorbed through rat skin to a low extent, 0.26 % within 24 hours.
The presence of carboxyl esterases in the skin completely hydrolyses the substance, only the resulting metabolite methacrylic acid was
demonstrated to pass through.
With respect to human skin, 14 times more efficient permeation through rat skin obtained in an epidermal PB-PK model developed in this study.

Executive summary:

The absorption of Lauryl methacrylate (LMA) was evaluated through whole rat skin and rat epidermis in an in vitro system.

The technique measures the rate of absorption of LMA across the rat skin and epidermis. Glass diffusion cells are employed to measure the amount of LMA that is received into a receptor chamber with respect to time, following the application of 100 µl/cm² of LMA to the epidermal surface. The mean rate of absorption was 26.2 µg cm-2 hr-1 for rat epidermis and 7.72 µg cm-2 hr-1 for whole rat skin.

The total amount of chemical that was absorbed during the time of exposure was 0.7 % (rat epidermis) and 0.26 % (rat whole skin) over 24 hours, respectively. LMA appears to be absorbed through rat skin and epidermis to a low extent As indicated by a PB-PK model used in this study, human skin is 14 times less permeable to LMA than rat skin.

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