Registration Dossier
Registration Dossier
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EC number: 201-297-1 | CAS number: 80-62-6
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- report has partly been reported in Betts et al., 2006
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The absorption of neat methyl methacrylate through human epidermis in vitro was examined under occluded and unoccluded conditions.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl methacrylate
- EC Number:
- 201-297-1
- EC Name:
- Methyl methacrylate
- Cas Number:
- 80-62-6
- Molecular formula:
- C5H8O2
- IUPAC Name:
- methyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Human abdominal whole skin (dermis plus epidermis) was obtained post-mortem from subjects of various ages.
Administration / exposure
- Type of coverage:
- other: occlusive or open
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 10 h
- Doses:
- 9430 mg/cm2
- No. of animals per group:
- 3 samples per treatment
- Control animals:
- no
Results and discussion
Percutaneous absorptionopen allclose all
- Time point:
- 1 h
- Dose:
- 9430 mg neat MMA/cm2
- Parameter:
- percentage
- Absorption:
- 2.41 %
- Remarks on result:
- other: occlusive conditions
- Time point:
- 1 h
- Dose:
- 9430 mg neat MMA/ cm2
- Parameter:
- percentage
- Absorption:
- 0.48 %
- Remarks on result:
- other: open conditions
- Time point:
- 10 h
- Dose:
- 9430 mg neat MMA/cm2
- Parameter:
- percentage
- Absorption:
- 15 %
- Remarks on result:
- other: occlusive conditions
- Time point:
- 10 h
- Dose:
- 9430 mg neat MMA/cm2
- Parameter:
- percentage
- Absorption:
- 0.56 %
- Remarks on result:
- other: open conditions
Any other information on results incl. tables
Significant levels of MMA were detected in the receptor fluid within 10 min of treatment in the presence or absence of occlusion. Under both conditions, maximal rates of absorption were recorded within the first hour of exposure, with higher values recorded following application under occlusion compared with open exposure (274 compared with 107 mg/cm2/hr). The absorption rate for open application of MMA decreased very rapidly and profoundly thereafter, with an average rate of 3.5 mg/cm2/hr recorded over the 10-hr period. A less marked decrease in absorption rate was recorded over the same time period for occluded epidermis (152 mg/cm2/hr). The differences in absorption rate were paralleled by differences in the mean percentage dose of MMA absorbed. Within 1 hr of treatment, considerably more MMA had been absorbed from occluded, compared with unoccluded, tissue (2.41% and 0.48%, respectively). Given that the rate of absorption from unoccluded epidermis decreased very markedly 1 hr after application, it is not surprising that the total percentage of the dose absorbed after 10 hr had risen to only 0.56%. In contrast, after 10 hr of occlusion, 15% of the total applied dose of MMA was detected in the receptor fluid. Given the volatility of this material, the marked reduction in absorption of MMA under unoccluded conditions is likely to be a result of the loss, by evaporation, of MMA from the epidermal surface.
Applicant's summary and conclusion
- Conclusions:
- MMA absorption rate through occluded human epidermis was 152 mg/cm²/hr, representing a percentage of 2.4% of the applied amount after 1 h. The absorption rate though unoccluded (open) application decreased very rapidly after 10 minutes to an average rate of 3.5 mg/cm²/hr. The differences in absorption rate were paralleled by differences in the mean percentage dose of MMA absorbed and most likely reflected evaporation.
- Executive summary:
MMA absorption rate through occluded human epidermis was 152 mg/cm²/hr, representing a percentage of 2.4% of the applied amount after 1 h. The absorption rate though unoccluded (open) application decreased very rapidly after 10 minutes to an average rate of 3.5 mg/cm²/hr. The differences in absorption rate were paralleled by differences in the mean percentage dose of MMA absorbed and most likely reflected evaporation.
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