Registration Dossier
Registration Dossier
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EC number: 202-436-9 | CAS number: 95-63-6
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline in-vitro experimental study, published in peer reviewed literature, minor restrictions in reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro evaluation of the efficacy of skin barrier creams and protective gloves on percutaneous absorption of industrial solvents
- Author:
- Korinth, G., Geh, S., Schaller, K.H. and Drexler, H
- Year:
- 2 003
- Bibliographic source:
- Int. Arch. Environ. Health, 76, 382-386
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In an in vitro skin permeability study, the permeation of 1,2,4-trimethylbenzene through human skin was determined using static Franz diffusion cells.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,2,4-trimethylbenzene
- EC Number:
- 202-436-9
- EC Name:
- 1,2,4-trimethylbenzene
- Cas Number:
- 95-63-6
- Molecular formula:
- C9H12
- IUPAC Name:
- 1,2,4-trimethylbenzene
- Details on test material:
- - Name of test material (as cited in study report): 1,2,4-trimethylbenzene
- Purity: >99%
- Source; Fluka (Germany)
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Human skin from one donor obtained from a local hospital and stored for approximately 1 week at -20C.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: neat TMB, 10 or 50% TMB in ethanol
- Duration of exposure:
- 8h
- Doses:
- 128 µL/0.64cm3
Results and discussion
- Absorption in different matrices:
- Steady state status had not been attained after 8 h exposure.
64 µg penetrated untreated skin from neat 1,2,4-TMB, 77 µg penetrated from a 50% ethanolic solution of 1,2,4-TMB.
The presence of skin barrier cream enhanced penetration of 1,2,4-TMB from ethanolic solutions.
1,2,4-TMB was detected in the receptor fluid within 30 min of application to glove material.
Percutaneous absorption
- Dose:
- 128 µl/0.64cm2
- Parameter:
- percentage
- Absorption:
- ca. 0.1 %
- Remarks on result:
- other: 8 h
- Remarks:
- value calculated by reviewer = 0.057% (not reported in original publication)
Applicant's summary and conclusion
- Executive summary:
Steady state status had not been attained after 8 h exposure.
64 µg (0.057%) penetrated human skin when 1,2,4-TMB was applied at a rate of 128 µL/0.64 cm2.
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