Registration Dossier

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:
2003
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2,4-trimethylbenzene
- Purity: >99%
- Source; Fluka (Germany)
Radiolabelling:
no

Test animals

Species:
human
Sex:
not specified
Details on test animals 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.