3-chloroperbenzoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

In vivo in albino rabbits

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The test was started on April 13, 1987 and completed on May 6, 1987.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive 84-449, Annex V, Part B: Methods for the determination of toxicity, B.4. Acute toxicity, skin irritation, dated September 1984.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-chloroperbenzoic acid

EC Number:

213-322-3

EC Name:

3-chloroperbenzoic acid

Cas Number:

937-14-4

Molecular formula:

C7H5ClO3

IUPAC Name:

3-chlorobenzene-1-carboperoxoic acid

Test material form:

liquid - solid: mixture of

Remarks:

The substance in its marketed form is not in solid or granular form. The marketed product contains 18% water and is thus a wet, paste-like consistency.

Specific details on test material used for the study:

Two 50 g samples of the test substance were received from the sponsor on April 9, 1987. Each sample was designated: "metachlooperbenzoe zuur", Ch 04.87.006J. The test substance was named m-chloroperoxybenzoic acid.
Just prior to application, the test substance was moistened with water in a ratio of 1: 1 (w/w) , to ensure good contact with the skin of the rabbits.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Healthy male, young adult, New Zealand White albino rabbits obtained from ENKI-Konijnenfarm, Someren, the Netherlands, were used as the experimental animals. The body weight range was 2500-3500 g. The animals were identified by earmarking, and subsequently housed individually in suspended, galvanized cages, fitted with a wire-mesh floor and front. The cages were placed in a room, controlled for light (12 hours light/12 hours dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour) ,and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water were provided ad libitum.

Test system

Type of coverage:

not specified

Preparation of test site:

clipped

Remarks:

Electric clippers were used to remove the hair from the back and flanks of the animal.

Vehicle:

water

Remarks:

0.5 g of test material was moistened with 0.5 g of water.

Controls:

no

Amount / concentration applied:

Just prior to application, the test substance was moistened with water in a ratio of 1: 1 (w/w) , to ensure good contact with the skin of the rabbits.

Duration of treatment / exposure:

Exposure period: 4 hrs

Observation period:

Initial skin reaction was observed after 1 hr. Further readings were made after 24, 48 and 72 hours, and after 8,14 and 23 days.

Number of animals:

1 rabbit.

Details on study design:

The study was started with one rabbit. Depending on the severity of the skin effects observed in this animal it would be decided to conduct a full study with three rabbits or to use no more than one rabbit. After an acclimatization period of six days, i.e. one day prior to the start of the experiment, the hair was removed from the back and flanks of the animal using electric clippers in a way as to avoid abrasions.
An amount of 0. 5 g test substance moistened with 0. 5 g water was brought on a small area of intact skin under a plastic cup with a diameter of about 1 inch. The cup was fixed to the application site by means of adhesive tape and the entire trunk of the rabbit was wrapped with an impervious material to maintain the cup in position and to retard evaporation of volatile substances.
After an exposure period of 4 hours the cup and the test material applied were removed and one hour later, the resulting skin reactions were evaluated by the method of Draize et al. (J. Pharmacol. Exp. Ther. 82 (1944) 377-390).
One hour after treatment, the resulting skin effects were of a severe degree. Therefore, it was decided not to continue the study with another two rabbits.
Further readings were made after 24, 48 and 72 hours, and after 8,14 and 23 days.

EVALUATION OF SKIN REACTIONS (DRAIZE ET AL., 1944)
Value
A. Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness); eschar formation
(injuries in depth) 4

B. oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 millimeter) 3
Severe oedema (raised more than 1 millimeter,
extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 hr

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

Irritation was assessed also at 1 hour due to expected corrosive nature of the substance

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 hr

Score:

> 2 - <= 4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

Irritation was assessed also at 1 hour due to expected corrosive nature of the substance.

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 2 - <= 4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Skin irritation scores recorded at 1-72 hours after removal of the test substance are shown in table 1.

At 1 hour, and at 24, 48 and 72 hours after removal of the test substance, skin effects such as erythema could not be observed because of the ischemic necrosis or incrustation which was present on the entire site of the application.

The following skin effects were observed up to 72 hours after removal:

slight or severe oedema

- moderate to severe or severe ischemia

- slight haemorrhages

- moderate to severe incrustation

After 8 days, severe incrustation was observed.

After 14 days, slight incrustation and scar tissue formation were observed.

After 21 days, scar tissue was still observed.

TABLE 1 - SKIN IRRITATION SCORES OF M-CHLOROPEROXY BENZOIC ACID AT 1-72 HOURS AFTER A SINGLE 4-HOUR DERMAL EXPOSURE

Rabbit no.	Hours after removal of the test material
	1 hr		24 hr		48 hr		72 hr
	A	B	A	B	A	B	A	B
4423	4	4	4	4	4	2	4	2

A= erythema (including ischemia, haemorrhages and incrustation)

B = oedema

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

On the basis of the results obtained it is concluded that, according to the EEC-standards (as published in the Official Journal of the European Communities, L 257, Volume 26, 16 September 1983), m-chloroperoxybenzoic acid is irritating and corrosive to skin.

Executive summary:

1. A sample of m-chloroperoxybenzoic acid was examined for acute dermal irritating/corrosive properties in an experiment with one albino rabbit. The test substance was moistened with water, in a ratio of 1:1, before it was applied to the skin. The dermal exposure period was 4 hours.

2. The dermal effects and skin reactions observed consisted of severe oedema, severe ischemic necrosis, slight haemorrhages, severe incrustation and scar tissue formation. Because of the severe degree of the effects observed it was decided to use only one rabbit instead of three.

3. On the basis of the results obtained it was concluded that, according to the EEC-standards, m-chloroperoxybenzoic acid is irritating and corrosive to skin.