2-(2-ethoxyethoxy)ethanol

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Standard well reported study conducted according to GCP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Type of study / information:

Skin tolerability

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Evaluation of cutaneous irritation after a single application of test substance under occlusion for 48 consecutive hours in healthy volunteers.

GLP compliance:

yes

Remarks:

Good Clinical Practice

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-ethoxyethoxy)ethanol

EC Number:

203-919-7

EC Name:

2-(2-ethoxyethoxy)ethanol

Cas Number:

111-90-0

Molecular formula:

C6H14O3

IUPAC Name:

2-(2-ethoxyethoxy)ethan-1-ol

Details on test material:

- Name of test material (as cited in study report): Transcutol
- Physical state: Translucent liquid
- Lot/batch No.: 75412
- Storage condition of test material: Minimum 19C

Method

Ethical approval:

confirmed and informed consent free of coercion received

Details on study design:

Test substance is applied once only. After 48hrs the patches are removed and any remaining test substance on the surface of the treated area eliminated using a hydrophilic square pad. The cutaneous examinations were performed about 30 minutes after removal of the patches.
As well as the test substance , test chambers without the test article were also applied under the same conditions to act as negative control.
Standard inclusion/exclusion criteria applied to the volunteers.

Exposure assessment:

estimated

Details on exposure:

Application of test substance, about 0.02 ml per volunteer in a 10% (w/v) dilution in sterile water, on a surface of about 50mm2 located to the left of the spine. The test substance was placed in a 'Finn Chamber' which is an isolation chamber that ensures a good occlusion limited to the application area of the test substance. It is composed of an aliminium disc 8mm in diameter covering a contact surface of 50mm2. Each disc is individually mounted onto an adhesive tape. The test liquid is applied first onto a disc of filter paper (7mm) previously inserted into the disc, so that it absorbs a volume of about 0.02ml.

Results and discussion

Results:

14 volunteers were recruited and selected for the realisation of the study.
10 of them came to the testing facility and all were admitted and participated in the whole study. Their ages were from 19 to 41 years old.
No reaction of pathological irritation or significant cutaneous intolerance was noted.

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Conclusions:

The test substance was well tolerated under the conditions of this study

Executive summary:

The single epicutaneous application of 0.02ml of 2 -(2 -ethoxyethoxy)ethanol at 10% w/v in water under an occlusive patch test

for 48hrs in 10 healthy adult volunteers was well tolerated and shows low irritancy potential.