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Exposure related observations in humans: other data

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exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A published study containing sufficient details to regard it as reliable for use in hazard assessment. Limited experimental detail provided.

Data source

Reference Type:
The safety of propylene glycol and other humectants
Motoyoshi et al
Bibliographic source:
Cosmetics and Toiletries 99, 83-91

Materials and methods

Type of study / information:
Human skin irritation study
Endpoint addressed:
skin irritation / corrosion
Test guideline
no guideline required
Principles of method if other than guideline:
48 hr patch test
GLP compliance:
not specified

Test material

Details on test material:
EC Number 203-919-7
EC Name 2-(2-ethoxyethoxy)ethanol
CAS Number 111-90-0
Molecular formula C6H14O3
IUPAC Name 2-(2-ethoxyethoxy)ethanol
Type of substance
Composition mono constituent substance
Origin organic
Trade names DEGEE, diethylene glycol methyl ether
diethylene glycol monoethyl ether (Wako Junyaku). Unknown impurities.


Ethical approval:
not specified
Details on study design:
48 hr occlusive patch tests were conducted in 34 health Japanese male adults .
The size of lint used in the patch tests was a 15mm2 and the amount of substance applied was 0.05ml/patch of a 50% (w/w) solution on the upper back. Skin was scored 30 minutes after patch removal.
Exposure assessment:
not specified

Results and discussion

45% of those tested showed erythema, edema or vesicles. An additional 20 % had definite erythema and approximately 35% had possible erythema.

No other details were reported.

Applicant's summary and conclusion

The substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol is an analogue of the test substance used in the study.The test substance was a skin irritant under the conditions of this study.
Executive summary:

The substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol is an analogue of the test substance used in the study.In a 48hr occlusive patch irritation study in Japanese subjects, 0.05ml of 50% (w/w) 2 -(2 -ethoxyethoxy)ethanol induce irritation observed as erythema, edema or vesicles in most subjects. Similar results were seen with other tested substances such as propylene and dipropylene glycol.