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
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:
1958
Report Date:
1958

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The substance was applied (90% in water) in the form of a paste for 1, 5, 15 minutes or 20 hours to the rabbit skin on the back.
GLP compliance:
no
Remarks:
pre-GLP

Test material

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

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
other: untreated skin of same animal
Amount / concentration applied:
90% in water in the form of a paste (amount not specified)
Duration of treatment / exposure:
1 minute, 5 minutes, 15 minutes and 20 hours
Observation period:
8 days
Number of animals:
5 in total; substance has been applied on the skin of the back of all 5 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: concentrated Lutrol and 50% lutrol
- Time after start of exposure: see duration of exposure; 1 minute, 5 minutes, 15 minutes and 20 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Remarks:
(1, 5 and 15 minutes of exposure)
Basis:
mean
Time point:
other: 24 hours and 8 days
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
(1, 5 and 15 minutes of exposure)
Basis:
mean
Time point:
other: 24 hours and 8 days
Score:
0
Max. score:
4
Irritation parameter:
other: observations regarding skin irritation in case of 20 hours exposure
Basis:
mean
Remarks on result:
other: Slight erythema with individual hemorrhages at 24 hours. Circumscribed crusts (lentil-sized); fallen off at 8 days.
Irritant / corrosive response data:
The application for 1, 5 or 15 minutes on the back led to no findings within 8 days. After application for 20 hours, on the back, slight erythema was recorded with individual hemorrhages at 24 hours. Circumscribed crusts (lentil-sized; fallen off) were recorded at day 8 of the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met