OO-tert-butyl monoperoxymaleate

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Version from May 12, 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

EEC Publication No. L251, September 1984

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

OO-tert-butyl monoperoxymaleate

EC Number:

217-691-1

EC Name:

OO-tert-butyl monoperoxymaleate

Cas Number:

1931-62-0

Molecular formula:

C8H12O5

IUPAC Name:

(2Z)-4-(tert-butylperoxy)-4-oxobut-2-enoic acid

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 6

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.