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:
13 November 1990 - 16 November 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study with adequate description of species, method, and results, but limited reporting of husbandry and duration of observations limited to 72 hours.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: 16 CFR 1500 Modified
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
According to the protocol animals will be acclimated to the laboratory at least one day prior to testing and will be housed singly in wire meash suspension cages. Purina Laboratory Rabbit Chow (or comparable diet) and tap water will be provided ad libitum. Animals will be maintained on a 12 hour light/dark cycle.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
24 and 72 hours
Number of animals:
2 rabbits
Details on study design:
The animals in this study we also concurrently tested with this substance for eye irritation. Prior to administration to the eye, a 0.5 ml portion of the test material was applied to the intact shaved skin of rabbits and covered with gauze patched heald in place with adhesive tape and wrapped with a rubber dental dam. After 4 hours the wrapping was removed, and the test material was removed. The treated areas were examined at 24 and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
3
Max. score:
4
Reversibility:
not reversible

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation No. 1272/2008, classification of this substance as a skin irritant is required.
Executive summary:

The skin irritation potential of this substance was evaluated in rabbits. The animals in this study also were used to evaluated the eye irritation potential of this substance. Prior to administration to the eye, a 0.5 ml portion of the test material was applied to the intact shaved skin of two rabbits and covered with gauze patched heald in place with adhesive tape and wrapped with a rubber dental dam. After 4 hours the wrapping was removed, and the test material was removed. The treated areas were examined at 24 and 72 hours. The calculated mean 24 -72 hour scores for erythema and edema were 2.5 and 3.0, respectively. The effects were not reversible by the last observation at 72 hours. In accordance with EU CLP Regulation No. 1272/2008 classification as a skin irritant is required.