Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 25, 1977 to September 02, 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: generally accepted scientific principles and well documented study details, acceptable for assessment
Deviations:
not specified
Principles of method if other than guideline:
The skin irritation and/or sensitisation potential of the test substance was evaluated following repeated application under occlusive patch test conditions to the skin of human subjects.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
other: human, healthy volunteers

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Amount / concentration applied:
7.5% preparation of the test substance
Duration of treatment / exposure:
- Preliminary experiment: 24 h
Number of animals:
50
Details on study design:
The skin reactions (erythema, edema as well as other irritation signs) were then scored.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The absence of any visible irritation following an application indicated that the test substance was not acting as a primary irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was concluded to be a non irritating to skin.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance (purity not specified), according to the human repeated insult patch test (HRIPT). In the induction phase, a 7.5% test substance preparation (in distilled water) was applied epicutaneously to 50 healthy volunteers for 24 h under an occlusive type of coverage. The applications were done daily on Monday, Tuesday, Wednesday and Thursday for 3 consecutive weeks. After a rest period of ca. 2 weeks, the test substance was applied under the same conditions to a new site as a challenge. After 24 h, the occluded patch was removed and the site was read for immediate response. Follow-up readings were made 24, 48 and 72 h later. The skin effects were then scored for irritation (erythema, edema as well as other irritation signs). During Week 1 of the induction period, no visible irritation was observed in any of the 50 individuals, indicating that the test substance was not acting as a primary irritant. During the second week, visible irritation (slight erythema) was observed in one individual. During Week 3, irritation was recorded in 2 individuals (slight to marked erythema). This was considered as a manifestation of skin fatigue resulting from the cumulative effect of 11 or more applications. No visible irritation or skin sensitisation response was observed in any of the 50 individuals following challenge. The absence of any visible irritation resulting from the challenge application confirmed that the test substance was not acting as a primary skin irritant. Therefore, under the study conditions, the test substance was concluded to be no irritating to skin (Product Investigation Inc., 1977).