Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The dermal irritation was determined according to the EU Method B.4 and OECD Guideline 404 (Acute Dermal Irritation / Corrosion).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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:
Number of animals: 3
Animal weights: 2.2 to 2.4 Kg
Age of animals: 3-5 Months
Animal housing: in fully air-conditionned rooms
Ambient temperature: 18+-3°C
Relative humidity: 50+-20%
Lighting time: 12 hours per day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
0.5g of 5-Methylisoxazole-4-carboxylic acid pasted with 0.5mL isotonic saline.
The substance was applied over the whole surface of a 2.5*2.5cm cellulose patch on a piece of chirurgical plaster.
The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
Duration of treatment / exposure:
The exposure period was 4 Hours.
Observation period:
Examinations of the skin took place after 30-60 minutes, and 24, 48 and 72 hours after removal of the patches.
Number of animals:
3 Rabbits
Details on study design:
Erythema, eschar formation and oedema were evaluated numerically according to the technique of DRAIZE.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 2 Rabbits
Time point:
other: 30-60 Minutes
Score:
0
Max. score:
4
Reversibility:
fully reversible within: in 1 day
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 Day
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60 Minutes
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 Day
Score:
0
Max. score:
4
Irritant / corrosive response data:
30-60 minutes after removal of the plasters two animals showed very slight erythema. One day after removal of the plasters the irritations were reversible. Based on the result of the study, the test article is not irritating to skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
5-Methylisoxazole-4-carboxylic acid is not classified irritating to skin.