Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source; original study report not available.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1970
Report date:
2001

Materials and methods

Principles of method if other than guideline:
The present primary skin Irritation study was conducted with 10 human volunteers (5 men, 5 women) to determine whether the test compound was irritating to human skin or not. The test was conducted according to Shelanski & Shelanski (Occluded Patch Test, 1953).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-oxydiethanol
EC Number:
203-872-2
EC Name:
2,2'-oxydiethanol
Cas Number:
111-46-6
Molecular formula:
C4H10O3
IUPAC Name:
2-(2-hydroxyethoxy)ethan-1-ol
Details on test material:
purity: >96%; no further details provided.

Test animals

Species:
human

Test system

Type of coverage:
occlusive
Preparation of test site:
other: none
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Three areas of 3 cm x 3 cm each, were selected on the skin of the left arm of each individual. 10 mg of the test substance was applied to each area as a finely ground powder. The powder was covered with a lintine disc and secured to the arm by sealing around the edges with Blenderm tape.
Duration of treatment / exposure:
After 2 hours, the cover of one contact area was removed from each subject, the powder was lightly brushed away, and the site examined for skin reactions.
After 4 hours, the second disk was removed and the skin examined.
After 6 hours, the third disk was removed and the skin examined.
All treatment sites were examined immediately after disk removal, and then again at 1, 4 and 24 hour intervals.
Number of animals:
Ten human volunteers (5 men, 5 women)

Results and discussion

In vivo

Results
Irritation parameter:
other: each application site was examined for skin reaction
Basis:
other: each volunteer
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: One male subject exhibited slight erythema at 4 hours and marked erythema at 6 hours. One female subject exhibited slight erythema at 6 hours, and one female subject had marked erythema at 6 hours. All reactions disappeared in less than 24 hours.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
The test compound was able to elicite very mild primary irritation effect on human skin which however was fully reversible within less than 24 hours.