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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1990
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
dermal absorption
skin irritation / corrosion
repeated dose toxicity: dermal
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Dermal penetration and irritation study to determine the ability of triethylene glycol monomethyl ether (TGME), triethylene glycol monoethyl ether (TGEE), and TGBE to penetrate human skin and cause systemic toxicity from repeated dermal exposure.
In this experiment, human abdominal whole skin (dermis plus epidermis) samples were assessed in vitro. Skin samples were mounted in a glass diffusion apparatus that exposed 2.54 sq. cm of epidermal area for chemical absorbtion determinations.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: human abdominal whole skin (dermis plus epidermis) samples were assessed in vitro.
Subjects:
In this experiment, human abdominal whole skin (dermis plus epidermis) samples were assessed in vitro. Skin samples were mounted in a glass diffusion apparatus that exposed 2.54 sq. cm of epidermal area for chemical absorbtion determinations. Samples were tested for integrity (tritiated water diffusion through the skin prior to exposure), diffusion of glycol ethers through the skin, and epidermal damage after chemical exposures (increase in tritiated water diffusion following exposure).
Ethical approval:
confirmed, but no further information available
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
Dermal penetration and irritation study to determine the ability of triethylene glycol monomethyl ether (TGME), triethylene glycol monoethyl ether (TGEE), and TGBE to penetrate human skin and cause systemic toxicity from repeated dermal exposure.
In this experiment, human abdominal whole skin (dermis plus epidermis) samples were assessed in vitro. Skin samples were mounted in a glass diffusion apparatus that exposed 2.54 sq. cm of epidermal area for chemical absorbtion determinations. Samples were tested for integrity (tritiated water diffusion through the skin prior to exposure), diffusion of glycol ethers through the skin, and epidermal damage after chemical exposures (increase in tritiated water diffusion following exposure).
Examinations:
Dermal penetration and irritation study to determine the ability of triethylene glycol monomethyl ether (TGME), triethylene glycol monoethyl ether (TGEE), and TGBE to penetrate human skin and cause systemic toxicity from repeated dermal exposure.
Human abdominal skin (2.54 cm2) was mounted in a glass diffuison apparatus and the diffusion of TEGBE into the donator chamber was monitored during a 12 h-period using gas chromatography.

Results and discussion

Results of examinations:
No systemic effects were observed.
The mean steady state of absorption for triethylene glycol monobutyl ether was 22.2 ug/cm sq/hr (SD +/- 8.59), which was 100-fold less than that of ethylene glycol monomethyl ether. Test material did not increase permeability of the membrane (damage ratio of 1.26).
In this experiment, human abdominal whole skin (dermis plus epidermis) samples were assessed in vitro. Skin samples were mounted in a glass diffusion apparatus that exposed 2.54 sq. cm of epidermal area for chemical absorbtion determinations. Samples were tested for integrity (tritiated water diffusion through the skin prior to exposure), diffusion of glycol ethers through the skin, and epidermal damage after chemical exposures (increase in tritiated water diffusion following exposure). The three compounds crossed human epidermis at molar rates 170-330 times slower than the corresponding monoethylene glycol ethers. The skin damage ratio for TGME, however, was comparable to that of ethylene glycol monomethyl ether, indicating that the diffusion barrier function of the skin was slightly diminished after 12 hours of exposure.

Any other information on results incl. tables

In this experiment, human abdominal whole skin (dermis plus epidermis) samples were assessed in vitro. Skin samples were mounted in a glass diffusion apparatus that exposed 2.54 sq. cm of epidermal area for chemical absorbtion determinations. Samples were tested for integrity (tritiated water diffusion through the skin prior to exposure), diffusion of glycol ethers through the skin, and epidermal damage after chemical exposures (increase in tritiated water diffusion following exposure). The three compounds crossed human epidermis at molar rates 170-330 times slower than the corresponding monoethylene glycol ethers. The skin damage ratio for TGME, however, was comparable to that of ethylene glycol monomethyl ether, indicating that the diffusion barrier function of the skin was slightly diminished after 12 hours of exposure.

Applicant's summary and conclusion

Conclusions:
The three compounds crossed human epidermis at molar rates 170-330 times slower than the corresponding monoethylene glycol ethers. The skin damage ratio for TGME, however, was comparable to that of ethylene glycol monomethyl ether, indicating that the diffusion barrier function of the skin was slightly diminished after 12 hours of exposure.
No systemic effects were observed.
Executive summary:

Human abdominal skin (2.54 cm2) was mounted in a glass
diffuison apparatus and the diffusion of TEGBE into the
donator chamber was monitored during a 12 h-period using gas
chromatography. The diffusion rate of TEGBE was determined
to be 22 óg/cm2/h indicating a low skin permeability of the
compound.