Bisisobutyryl peroxide

Endpoint summary

Description of key information

The results for 30% diisobutyryl peroxide in a phlegmatizer indicates the registered substance is corrosive to the skin. At 30% diisobutyryl peroxide in a phlegmatizer is irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 14, 1989 - August 28, 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performe according to OECD guideline and GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2800 g
- Housing: The animal was housed in a suspended, galvanized cage, fitted with a wire-mesh floor and front
- Diet (e.g. ad libitum): standard laboratory rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): at least 40%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): natural day/night cycle

IN-LIFE DATES: August 14, 1989 - August 28, 1989

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

Skin readings were made at approximately one hour, 24, 48 and 72 hours, and at 8 and 14 days after treatment.

Number of animals:

1, the effects were of a very severe degree. Therefore, it was decided not to continue the study with another two rabbits.

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: 2.5 x 2.5 em patch
- Type of wrap if used: The patch was immediately placed on the intact skin and fixed to the application site by means of adhesive tape (Leukopor, BDF). The entire trunk of the rabbit was wrapped with a self-adhesive-gauze (Fixomull, art. no. 2112, BDF, W.-Germany) to maintain the patch in position.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No details on removal.
- Time after start of exposure: After an exposure period of 4 hours the patch and the material applied were removed.

SCORING SYSTEM: Draize
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: ischemia, haemorrhages, and incrustation) 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:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: scar tissue was observed after 14 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: scar tissue was observed after 14 days

Irritant / corrosive response data:

At 1, 24, 48, and 72 hours after removal, the skin effects observed consisted of severe ischemic necrosis and severe oedema.
At 8 days after treatment, severe incrustation was observed on the entire area of the application site.
At 14 days after treatment, the incrustation had loosened and scar tissue was now observed on the entire area of the application site.

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

The results for 30% diisobutyryl peroxide in a phlegmatizer would result in a classification as corrosive to the skin.

Executive summary:

A 30% dilution of diisobutyIyl peroxide was examined for acute dermal irritating/corrosive properties in an experiment with one albino rabbit. The dermal exposure period was four hours. The test substance caused severe ischemic necrosis, severe incrustation, and severe oedema. At 14 days after treatment, scar tissue was observed on the entire area of the application site. Because of the severe degree of the skin effects, the study was conducted with only one animal instead of three. On the basis of the results obtained it was concluded that, under the conditions of this study, a 30% dilution of diisobutyryl peroxide is corrosive to skin.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 14, 1989 - August 28, 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performe according to OECD guideline and GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2604 g
- Housing: The animal was housed in a suspended, galvanized cage, fitted with a wire-mesh floor and front
- Diet (e.g. ad libitum): standard laboratory rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): at least 40%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): natural day/night cycle

IN-LIFE DATES: August 14, 1989 - August 28, 1989

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye remaining untreated, served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

Ocular reactions were judged at circa one hour, at circa 24, 48, 72 hours, and at 8, and 14 days after treatment

Number of animals or in vitro replicates:

1, 1, the effects were of a very severe degree. Therefore, it was decided not to continue the study with another two rabbits.

Details on study design:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: No data

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: ischemic necrosis of the conjunctivae

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

other: ocular discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14-days

Irritant / corrosive response data:

Approximately one minute after treatment the animal began to scream for about one minute. This screaming is considered to be a clear sign of pain due to treatment with the test substance.
At one hour after treatment, the eye effects observed consisted of moderate redness of the conjunctivae, severe swelling of the conjunctivae. In addition, moderate ocular discharge was observed. At 24 hours after treatment, the eye effects observed consisted of slight corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge. At 48 and 72 hours after treatment, the eye effects observed consisted of moderate corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge. During the following five days, the eye effects partly cleared. At 8 days after treatment, the eye effects observed consisted of slight corneal opacity, slight redness of the conjunctivae, slight swelling of the conjunctivae, and slight ocular discharge. At 14 days after treatment, the eye effects had cleared completely.

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

The results for 30% diisobutyryl peroxide in a solvent would result in a classification as irritating to the eyes.

Executive summary:

A 30% dilution of diisobutyIyl peroxide was examined for acute eye irritating/corrosive properties in an experiment with one albino rabbit.

The test substance caused moderate corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge.

At 14 days after treatment, the eye effects had cleared completely. Because of the severe degree of the effects observed and for ethical

reasons, it was decided to use for this study only one animal instead of three.

On thee basis of the results obtained it was concluded that, under the conditions of this study, a 30% dilution of diisobutyIyl peroxide is irritating, but not corrosive to eyes.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The results for 30% diisobutyryl peroxide in a phlegmatizer would lead to a classification as irritating to the eyes. There is no data for higher concentrated substance. Considering the nature and the severity of the effects at 30% the substance is classified as cat. 2 - causes serious eye irritation. The results for 30% diisobutyryl peroxide in a phlegmatizer would lead to a classification as corrosive to the skin.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the available data the substance is classified as cat. 2, causes serious eye irritation and Cat 1 for skin corrosion.