2-(2-(2-methoxyethoxy)ethoxy)ethanol

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptably documented study which meets basic scientific principles and contains sufficient detail to be able to judge the results reliable as a contribution to the understanding of the toxicokinetics of this substance.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Triethylene glycol ethers: Evaluation of in vitro absorption through human epidermis, 21 day dermal toxicity in rabbits and a developmental screen in rats

Author:

Leber AP, Scott RC, Hodge MCE, Johnson D, Krasavage WJ

Year:

1990

Bibliographic source:

J Am Coll Toxico, 9 (5) 507-15

Reference 2

Reference Type:

secondary source

Title:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

Author:

OECD

Year:

1996

Bibliographic source:

OECD SIAM 4, Tokyo, Japan

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 428 (Skin Absorption: In Vitro Method)

Deviations:

not specified

Principles of method if other than guideline:

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. Further reference in the Leber publication is given to the method of Dugard et al (Env Hlth Persp, 17, 193, 1984)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

EC Number:

203-962-1

EC Name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

Cas Number:

112-35-6

Molecular formula:

C7H16O4

IUPAC Name:

2-[2-(2-methoxyethoxy)ethoxy]ethan-1-ol

Details on test material:

- Name of test material (as cited in study report): Poly-solv TM
- Physical state: liquid
- Analytical purity: 99.9% pure
- Supplier: Olin Corporation, New Haven, CT

- Control substance: Ethylene glycol monomethyl ether, ex ICI, UK. 100% pure.

Radiolabelling:

no

Test animals

Species:

human

Strain:

not specified

Sex:

not specified

Administration / exposure

Details on in vitro test system (if applicable):

SKIN PREPARATION
- Source of skin: human, obtained post mortem, predominantly from females of varied age.
- Ethical approval if human skin:
- Type of skin: abdominal whole skin (dermis plus epidermis).
- Preparative technique: samples of epidermis separated from dermis following immersion in water at 60C for 45-60s.
- Membrane integrity check: tested using tritiated water in 0.9% saline monitored over 3-6 hours

PRINCIPLES OF ASSAY
- Diffusion cell: Epidermal sample mounted in a glass diffusion apparatus. 2.54cm2 area of exposure. Measurements made over 12 hours in triplicate
- Receptor fluid: 0.9% saline
- Solubility of test substance in receptor fluid: fully miscible
- Reference substance(s): ethylene glycol methyl ether

Results and discussion

Any other information on results incl. tables

Diffusion rate determined to be 34 +/-7.7ug/cm2/hr (n=6). (Figure for reference compound ethylene glycol methyl ether was 2200ug/cm2/hr.) Damage ratio 3.36 indicating no some effect on skin barrier properties following exposure resulting in a slight diminition of the barrier properties of the skin following exposure. This diffusion rate is 1.5% of that obtained for 2 -methoxyethanol.

Applicant's summary and conclusion

Executive summary:

An in vitro study determined that the permeability of 2-(2-(2 -methoxyethoxy)ethoxy)ethanol to human skin is quite low. The permeability co-efficient was determined to be 34 +/-7.7ug/cm2/hr, which is around 1.5% of the skin penetration rate of the shorter chain glycol ether ethylene glycol methyl ether. Exposure to the substance caused slight deterioration of skin barrier properties as quantified by the damage ration (rate of permeation of tritiated water through the skin before and after exposure.).