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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 4 - July 8, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Part B, Method B4, Commission Directive 92/69/EEC, Acute Toxicity (Skin Irritation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
414-490-2
EC Name:
-
Cas Number:
154212-59-6
Molecular formula:
C11H9ClN2O5S
IUPAC Name:
4-nitrophenyl 1,3-thiazol-5-ylmethylcarbonate hydrochloride

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Labs, Montreal, Canada
- Age at study initiation: 10 - 15 weeks approx.
- Weight at study initiation: 2 - 3kg
- Housing: Individual stainless steel ventilated hanging cages
- Diet (ad libitum): Certified High Fibre Rabbit Chow®
- Water : ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65 - 70°
- Photoperiod (hrs dark / hrs light): 12 hour daily light cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: slightly moistened with water
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4hr
Observation period:
½hr, 24hr, 48hr and 72hr after dressing removed, plus days 4, 7, 10 and 14.
Number of animals:
6
Details on study design:
100 x 100mm area of dorso-lumbar region clipped on day prior to treatment. Wetted material placed under 25 x 25mm gauze pad. Animals were not restrained during the exposure period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0-14 days
Score:
0
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: value at end of observation period 1; se comments
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0-10 days
Score:
0
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
Small scabs and/or dark (bluish green) spots were observed at the site of exposure in 4 rabbits over numerous observation periods and in 1 rabbit at a single observation period.
The largest spots or scabs were about 0.5cm in diametre. Very slight erythema and/or edema was noted at times at the outer edge of the scabs or spots.
All signs of dermal irritation at the exposure site were completely reversible in 5 of the rabbits by day 14. In the remaining rabbit, very slight erythema and small scabs were still noted on day 14.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was classified as irritating to the skin.