Registration Dossier

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A study reported in sufficient detail to provide reliable information on the in vitro absorption of methoxyethanol through human skin. The study seems to follow main requirements of the OECD protocol although not all information is included in publication to judge if it is followed exactly.

Data source

Reference
Reference Type:
publication
Title:
Absorption of some glycol ethers through human skin in vitro.
Author:
Dugard PH, Walker M, Mawdsley SJ et al
Year:
1984
Bibliographic source:
Env Hlth Persp, 57 , 193-7

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Principles of method if other than guideline:
Follows principles of OECD428 with following exceptions: The test substance was not radiolabelled therefore there was no attempt at a mass balance. Not enough raw data reported to meet protocol requirements. Some minor detail of experimental methods also lacking.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid
- Source: ICI Petrochemicals and Plastics Division, Wilton, UK
- Analytical purity: >98%

Test animals

Species:
human

Administration / exposure

Vehicle:
other: none. Test carried out with undiluted material
Duration of exposure:
single dose. 8 hours

Results and discussion

Absorption in different matrices:
ABSORPTION:
Steady state was achieved during the experiment; maximum rate was achieved after 5 hours. At 2.5hours the adsorption rate was only half of the 5 hour rate, generally showing a 1-3hour lag time. The permeability constant was calculated at 0.00028cm/hr with a rate of absorption of 2.82 +/-2.63mg/cm2/hr, based on 22 determinations. The damage ration (ratio of tritiated water permeability before and after exposure) was 3.51+/-1.47 (20 determinations) which is higher that the 1-2 figure for controls, indicating slight irreversible effects on barrier function following exposure to methoxyethanol.

Applicant's summary and conclusion

Conclusions:
Methoxyethanol is readily absorbed through human skin.
Executive summary:

An in vitro dermal absorption study using human skin showed that methoxyethanol readily passes through the stratum corneum and causes slight but detectable damage to the skin.