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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

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Administrative data

exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Standard well reported study conducted according to GCP.

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of study / information:
Skin tolerability
Endpoint addressed:
skin irritation / corrosion
Test guideline
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:
Good Clinical Practice

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
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


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:
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

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

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.