2-isopropoxyethanol

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: Recent study, well reported in open literature.

Data source

Reference

Reference Type:

publication

Title:

Venier M, Adami G, Larese F, Maina FG, Renzi N.

Author:

Venier M, Adami G, Larese F, Maina FG, Renzi N.

Year:

2004

Bibliographic source:

Toxicology in Vitro 18, 665–671.

Materials and methods

Principles of method if other than guideline:

Absorption across full thickness human skin was evaluated in vitro. Skin membranes were placed in static diffusion cells and both neat and 50% water diluted substance was included in the donor chamber for 8 h. Concentrations in the receptor chamber were measured by GC/FID.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-isopropoxyethanol

EC Number:

203-685-6

EC Name:

2-isopropoxyethanol

Cas Number:

109-59-1

Molecular formula:

C5H12O2

IUPAC Name:

Propan-2-ol

Details on test material:

Source: BDH Laboratories Supplies (Poole, England).
Purity: >98%.

Radiolabelling:

no

Administration / exposure

Vehicle:

other: 50% in 0.9% NaCl in water.

Details on in vitro test system (if applicable):

SKIN PREPARATION
- Source of skin: Surgical waste. Male and females, 47–62 years old.
- Ethical approval if human skin: no information.
- Type of skin: Human abdomen full thickness.
- Preparative technique: Subcutaneous fat removed and hair shaved.
- Thickness of skin (in mm): 1mm average.
- Membrane integrity check: Method of storage shown not to change permeability in separate studies (Franz, 1975; Lawrence, 1997).
- Storage conditions: -25 C for a period up to 4 months.

PRINCIPLES OF ASSAY
- Diffusion cell: static diffusion cells following the Franz Method. 3.29cm2 exposed skin area.
- Receptor fluid: 14ml 0.9% NaCl solution in water, stirred continuously.
- Solubility of test substance in receptor fluid: fully miscible.
- Static system: yes
- Test temperature: 32C (comparable to hand temperature.)
- Occlusion: yes
- Other: Substance was applied as neat liquids (0.2ml) or as 50% (v/v) aqueous solutions under infinite dose. Aliquots of 1.5 ml drawn from receiving solution of each cell by syringe at 0.5, 1, 2, 4 and 8 hr. This volume was immediately replaced by adding fresh saline solution. The samples were frozen until analysis by GC/FID analysis.

Results and discussion

Percutaneous absorption

Percutaneous absorption 1

Remarks on result:

other: Average flux

Remarks:

Neat compound: 240±62µg/cm2/hr

Percutaneous absorption 2

Remarks on result:

other: Average flux

Remarks:

50% aqueous solution: 246±22µg/cm2/hr

Any other information on results incl. tables

Other reported data:

Parameter	Neat solution	50% aqueous solution
Lag time (h)	1.32±0.63	1.97±0.20
Kp (µm/h)	27±18	044±10
Total recovered dose inreceptor fluid (% of dose)	0.91	1.55

Applicant's summary and conclusion

Executive summary:

In an in vitro skin permeation study, the rate of isopropyl glycol ether penetration in vitro through human skin was determined. The rate of flux of neat substance was measured at 240 ± 62ug/cm2/hr. The rate of flux did not change when the substance was present as a 50% aqueous solution.