Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In a reliable in vivo skin irritation study New Zealand White rabbits were exposed to the substance by dermal application. Severe oedema, severe ischemic necrosis, slight haemorrhages, severe incrustation and scar tissue formation were observed. On the basis of the results obtained it was concluded that, according to the substance is irritating and corrosive to skin.

In a reliable in vivo eye irritation study New Zealand White rabbits were exposed to the substance by instillation of the substance into one eye. The corresponding eye of the same animal was left untreated and acted as concurrent control. The substance produced very severe eye lesions, such as complete corneal opacity and ischemic necrosis of the conjunctivae. No significant recovery of the cornea lesions was expected to occur. On the basis of the results obtained it was concluded that, under the conditions of this study the substance is severely irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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
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.
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.
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
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
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
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.
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

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

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was started on April 13, 1987 and terminated on April 16, 1987.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Guideline/protocol followed not stated.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Two 50 g samples of the test substance received from the sponsor on April 9, 1987. Each sample was designated: "metachlooperbenzoe zuur", Ch 04.B7.006J. The test substance was named m-chloroperoxybenzoic acid.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
An amount of 0.1 g of the undiluted test substance was allowed to fall on the everted lower lid of the right eye of the rabbit.
Duration of treatment / exposure:
After administration the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.
Observation period (in vivo):
The control eye and test eye were examined after one hour and after 24, 48 and 72 hours.
Number of animals or in vitro replicates:
Only 1 animal was used in this study.
Details on study design:
The study was started with one rabbit. Depending on the severity of the eye 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.
The eyes of the rabbits provisionally selected were examined within 24 hours before testing. One animal without observable eye effects was used.
An amount of 0.1 g of the test substance was allowed to fall on the everted lower lid of the right eye of the rabbit. After administration the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The left eye remaining untreated, served as a control.
The test eye was not washed out following administration and the animal was released immediately.
After 24 hours, the resulting eye effects were very severe. Therefore, it was decided not to complete the study with another two rabbits. Ocular reactions were judged using the scoring scale which is given in an appendix at the end of this report (see page 11).
The control eye and test eye were examined after one hour and after 24, 48 and 72 hours.

Scale for scoring ocular lesions
Cornea:
Opacity-degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4

Iris
Normal 0
Folds above normal, congestion, swelling, circumcorneal
injection (any or all of these or combination of any thereof)
iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any
or all of these) 2

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not
easily discernible 2
Diffuse beefy red 3

Chemosis
No swelling 0
Any swelling above normal (including nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hr
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks:
The study was terminated after 72h due to considerable discomfort for the animal.
Remarks on result:
probability of severe irritation
Remarks:
Irritation was assessed also at 1 hour due to expected corrosive nature of the substance.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks:
The study was terminated after 72h due to considerable discomfort for the animal
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hr
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks:
The study was terminated after 72h due to considerable discomfort for the animal.
Remarks on result:
probability of severe irritation
Remarks:
Irritation was assessed also at 1 hour due to expected corrosive nature of the substance.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks:
The study was terminated after 72h due to considerable discomfort for the animal.
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Remarks on result:
not measured/tested

After 1-72 hours, eye effects such as redness of the conjunctivae could not be observed because ischemic necrosis was present on the entire surface of the conjunctivae (including the nictitating membrane). In addition, after 24-72 hours, also eye effects such as iritis could not be observed because complete corneal opacity was present.

After one hour, the eye effects which could be observed consisted of moderate corneal opacity, slight iritis, ischemic necrosis of the conjunctivae, and moderate swelling of the conjunctivae.

After 24 hours, the eye effects consisted of complete corneal opacity, ischemic necrosis of the conjunctivae, and severe swelling of the conjunctivae.

After 48 and 72 hours, the eye effects consisted of complete corneal opacity, ischemic necrosis of the conjunctivae, and moderate swelling of the conjunctivae.

These severe eye effects resulted in considerable discomfort for the test animal. Since, moreover, the cornea lesions were expected to be irreversible (on the basis of comparable results obtained in earlier studies conducted in this Institute), it was decided to kill the animal after the 72-hour observation.

INDIVIDUAL SCORES AWARDED TO THE OCULAR LESIONS ELICITED BY M-CHLOROPEROXYBENZOIC ACID

Time point (hours)

Rabbit Number

Cornea Opacity

Iris

Conjuctiva

Redness

Chemosis

1

4405

2

1

?1.)

2

24

4405

4

n.d.2.)

?

3

48

4405

4

n.d.

?

2

72

4405

4

n.d.

?

2

1) redness could not be scored because ischemic necrosis of the conjunctivae( including the nictitating membrane) was present on the entire surface of the conjunctivae

2) n.d.= not discernible

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
On the basis of the results obtained it is concluded that, under the conditions of this study and according to the EEC-standards (as published in the Official Journal of the European Coimm.mities, L 257, Volume 26, 16 September 1983), undiluted m-chloroperoxybenzoic acid is severely irritating to eyes.
Executive summary:

1. A sample of m-chloroperoxybenzoic acid was examined undiluted for acute eye irritating properties in an experiment with one albino rabbit.

2. The undiluted test substance caused very severe eye lesions, such as complete corneal opacity and ischemic necrosis of the conjunctivae. Since no significant recovery of the cornea lesions was expected to occur and for humane reasons, it was decided to use only one rabbit instead of three and to kill the animal after the 72-hour observation.

3. On the basis of the results obtained it was concluded that, under the conditions of this study and according to the EEC-standards, undiluted m-chloroperoxybenzoic acid is severely irritating to eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the findings of reliable in vivo dermal and eye irritation studies conducted on the substance, classification of the substance is justified.