Dibenzoyl peroxide

Endpoint summary

Description of key information

The acute oral toxicity of benzoyl peroxide is low: LD50 in mice >2,000 mg/kg, and in rats 5,000 mg/kg. No deaths occurred in male rats following inhalation of 24.3 mg/l.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study was conducted according to OECD guideline and according to GLP. The report is in korean but the summary tables and the individual data are reported in English. It is to be noted that the study was used as key study in the SIDS report (2002) and was quoted Kilimish 1.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

ICR

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age of animals: 5 weeks

Route of administration:

oral: gavage

Vehicle:

other: 0.5 percent methylcellulose sol.

Details on oral exposure:

Volume administered : 10 ml/kg

Doses:

2 000 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsyof all dosed animals

Statistics:

not applicable

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality

Mortality:

No mortality

Clinical signs:

other: The only clinical symptom observed in 2000 mg/kg dose groupe was piloerection. This symptom was reversible after one day.

Gross pathology:

No abnormal finding was observed in all dosed animals at necropsy.

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Under the experimental conditions, the oral LD0 of dibenzoyl peroxide is higher than 2000mg/kg in ICR mouse.

Executive summary:

The Acute oral toxicity of dibenzoyl peroxide was evaluated in rats according to OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female ICR mouse were given a single oral dose of 2000 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14).

During exposure, the only clinical sign observed was piloerection. This symptom was reversible after one day. No animal died following exposure. At necropsy, no abnormal finding was observed in all dosed animals.

Under these experimental conditions, the oral LD0 of dibenzoyl peroxide is expected to be more than 2000 mg/kg in ICR mouse.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was conducted in accordance with a recognized scientific procedure for analyzing the acute inhalation toxicity of a test material in experimental animals. However, only males were tested and no gross pathology results were reported.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

only one sex used (males), few data are provided on exposure conditions.

Principles of method if other than guideline:

Federal Hazardous Substances Act, Chapter II, Title 16 CFR

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Spartan albino

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 232-248 g
- Housing: by groups of 5 animals, in metal cages
- Food and water were available ad libitum pre- and post-exposure

ENVIRONMENTAL CONDITIONS
- Temperature and humidity were controlled quarters throughout the pre-exposure and post-exposure periods

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

A single group of 10 male rats were placed in a sealed 59.1 liter glass chamber and exposed for 4 hours to a dynamic atmosphere of test material.

Analytical verification of test atmosphere concentrations:

no

Remarks:

Concentrations were calculated

Duration of exposure:

4 h

Concentrations:

24.3 mg/l (the physical properties of the test material prohibited exposure of the test rats to highest atmospheric concentrations).

No. of animals per sex per dose:

10 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (then the rats were sacrified)
- Frequency of observations and weighing: during the expsoure period, the rats were observed continuously for changes in behavior and/or appearance
- Necropsy of rats who died during or after the exposure: yes
- Necropsy of survivors performed: no

Statistics:

not applicable

Preliminary study:

not applicable

Sex:

male

Dose descriptor:

LC0

Effect level:

24.3 mg/L air

Exp. duration:

4 h

Remarks on result:

other: no mortality

Mortality:

No mortality was observed at a single dose of 24.3 mg/L.

Clinical signs:

other:

Body weight:

Body weight gain was determined to be normal throughout study.

Gross pathology:

not performed (none of the animals died during and after the exposure)

Other findings:

No more data

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

No mortality occured at a concentration of 24.3 mg/L of dibenzoyl peroxid (no highest concentration could be tested, limitations from the physical properties of the substance).

Executive summary:

The acute inhalation toxicity of dibenzoyl peroxide was evaluated in a 4-hour, single-exposure study in rats according to a method similar to the OECD Guideline 403 (May 12^th1981). A limit test was performed: dibenzoyl peroxide was administered to a single group of ten male rats (Spartan strain) via whole-body vapor exposure at concentrations of 24.3 mg/L during 4 hours.

Mortality, clinical observations for clinical signs and body weight changes were evaluated over a 14-day observation period. Detailed clinical observations were conducted immediately following each exposure at 1 day, 2 days, and 5 days post-exposure.

No mortality occured during the exposure and during the post-exposure period.

During the exposure period, eye squint, dyspnea, salivation, lacrimation, erythema, increased and decreased respiratory rates, and increased and decreased motor activity were observed. After 24 hours post-exposure, all rats appeared normal. Observable signs after 48 hours post-exposure were soft stools. All animals appeared normal from day 5 until the end of the study. A few of the rats showed signs of ocular irritation (corneal opacity, ulceration of corneal surface)

Based on the results of this results, LD50 is expected to be more than 24.3 mg/L in rats, Spartan strain following a whole-body exposure to dust during 4 hours.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

24 300 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

The acute oral toxicity of benzoyl peroxide is likely to be low. In a key acute oral toxicity test with ICR mice, a limit test at dose level of 2,000 mg/kg benzoyl peroxide was carried out in a group of 5 males and 5 females using OECD TG 401 (NIER Korea, 2001). There were no deaths in treated animals. No significant findings were observed at necropsy. The only clinical symptom observed in the highest dose group was piloerection. Similar results were obtained in another acute oral study in rats. No mortality, toxic symptoms or signs were reported at the single dose of 5,000 mg/kg (Wazeter and Goldenthal, 1973).

Acute inhalation toxicity:

In an acute inhalation study, a single group of 10 male rats were placed in a sealed 59.1 liter glass chamber and exposed to a dynamic atmosphere containing the dust of benzoyl peroxide for 4 hrs. All the rats exposed to 24.3 mg/l of 78 % benzoyl peroxide, survived during the 14 days observation period. Observable signs during the 4 hr exposure period were eye squint, dyspnea, salivation, lacrimation, erythema, increased and decreased respiratory rates, and increased and decreased motor activity. A few of the rats showed ocular irritation at 5 days after exposure (Wazeter and Goldenthal, 1973).

Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – inhalation endpoint
Key study

Justification for classification or non-classification

According to EU Regulation (EC) N0. 1272/2008 (CLP), dibenzoyl peroxide is not classified for acute oral toxicity (LD50>2000 mg/kg bw) and for acute inhalation toxicity (LC50 >24.3 mg/L).