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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:
1993-01-12 to 1993-05-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Version from May 12, 1981
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
EEC Publication No. L251, September 1984
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
SOURCE OF TEST MATERIAL
- CAS No.: 1931-62-0
- Bulk Density: 0.48 g/ml
- Source and lot/batch No.of test material: 221190 ex PDD
- Expiration date of the lot/batch: 1993-07-01
- Purity test date: 1993-01-18
- Purity: approx. 98%


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in refrigerator in the dark
- Stability under test conditions: stable

Specific details on test material used for the study:
The powdery test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal's skin.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren , The Netherlands
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2312 - 2533 grams
- Housing: Individually in label led cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen , The Netherlands)
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm , Hope Farms, Woerden , The Netherlands) approx. 100 gram per day.
- Water (e.g. ad libitum): Free access to tap-water dil uted with decalcified water .
- Acclimation period: Seven days before start of treatment under test conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21.5°C
- Humidity (%): 25-50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
The powdery test substance was moistened with distilled water, immediately before application
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.5 gram of the test substance
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal fur, exposing area of approx. 150 square centimeters
- Type of wrap if used: Scotchpaknon-woven patch (2x3 cm, 3M, St.Paul, U.S.A.) mounted on Micropore tape (3M, St. Paul, U.S.A .).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4 hours, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue

OBSERVATION TIME POINTS
-1, 24, 48 and 72 h after removal of the dressings and remaining test substance

SCORING SYSTEM:
- Scoring system: see table 1 in "Any other information on materials and methods incl. tables"
- Method of calculation: A primary irritation index was calculated by combining the average skin, the degree of irritation can be obtained by the primary irritation index (see table 2 in "Any other information on materials and methods incl. tables) as well as irritation scores for erythema and oedema after 24 and 72 hours . Using the table of primary irritation index (see table 2, chapter "Any other information on materials and methods incl. tables), the degree of irritation was obtained (Draize, J.H. , Woodard, G. and Calvery, H.O., 1944) .

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin irritation and corrosion was caused by the test substance after a 4 h dermal application. No staining of the treated skin by the test substance was observed.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 3: Individual skin irritation scores

Animal No.1, Skin Irritation Scores Post-Application after
Observation 24 h 48 h 72 h average score (24, 48 and 72 hours)
Erythema 0 0 0 0
Oedema 0 0 0 0
Animal No.2, Skin Irritation Scores Post-Application after
Observation 24 h 48 h 72 h average score (24, 48 and 72 hours)
Erythema 0 0 0 0
Oedema 0 0 0 0
Animal No.3, Skin Irritation Scores Post-application after
Observation 24 h 48 h 72 h average score (24, 48 and 72 hours)
Erythema 0 0 0 0
Oedema 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an in vivo acute skin irritation/corrosion study in rabbits according to OECD 404, OO-tert-butyl monoperoxymaleate did not produce any irritating effects.
Executive summary:

In a primary dermal irritation study (OECD 404), young adult White New Zealand male rabbits were dermally exposed to 0.5 gram OO-tert-butyl monoperoxymaleate (98% purity) moistened with distilled water for 4 hours to 150 square centimetres body surface. 4 hours after application, the dressing and the remaining substance has been removed from the skin. Animals then were observed for 72 h. Irritation was scored by the method of Draize. No skin irritation nor corrosion was caused by the test substance after a 4 h dermal application. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Under the condition of the present study, no skin irritation or corrosion was caused by OO-tert-butyl monoperoxymaleate after a 4 h dermal application. In this study, OO-tert-butyl monoperoxymaleate is not irritating to the skin according to CLP criteria.