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BENZOYL PEROXIDE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Benzoyl peroxide is a white, granular, crystalline solid with a slightly bitter odor similar to almonds.

Specific Substances

    1) Dibenzoyl peroxide
    2) Benzoyl superoxide
    3) Oxylite
    4) Benoxyl Lucidol
    5) CAS 94-36-0
    6) DIBENZOYL PEROXID (GERMAN)
    7) DIBENZOYL PEROXIDE, NOT MORE THAN 62% WITH NOT LESS THAN 28% INERT SOLID AND NOT LESS THAN 10% WATER
    8) PANOXYDERM
    9) PANOXYDEX
    1.2.1) MOLECULAR FORMULA
    1) C14H10O4

Available Forms Sources

    A) FORMS
    1) Benzoyl peroxide exists as a white, granular, crystalline solid (Bingham et al, 2001; CHRIS , 2000; Lewis, 2000; ITI, 1995; Sittig, 1991). It is tasteless (Lewis, 2000; ITI, 1995) and has been described both as having a slightly bitter odor similar to almonds (Bingham et al, 2001; ITI, 1995) and as being odorless (CHRIS , 2000; Lewis, 2000).
    2) Benzoyl peroxide is available in 98% grade in the dry form, in grades ranging from 70% to 78% wet, and is available in the form of varied dibenzoyl peroxide and liquid plasticizer (such as tricresyl phosphate and silicon oil) pastes (CHRIS , 2000; HSDB , 2000).
    B) SOURCES
    1) Benzoyl peroxide is formed by:
    a) Reaction of sodium peroxide with benzoyl chloride in water (Bingham et al, 2001).
    b) Interaction of benzoyl chloride and a cooled solution of sodium peroxide (HSDB , 2000; Budavari, 1996).
    c) Reaction of sodium hydroxide, benzoyl chloride, and hydrogen peroxide (HSDB , 2000).
    d) Reaction of benzoyl chloride and hydrogen peroxide (dehydrochlorination) (HSDB , 2000; Ashford, 1994).
    2) Benzoyl peroxide is not known to exist as a product of nature and is thought to be purely of anthropogenic origin (HSDB , 2000).
    C) USES
    1) Benzoyl peroxide is used in varied capacities, including the manufacture of pharmaceuticals and cosmetics (HSDB , 2000; Lewis, 1997; ITI, 1995). It possesses antibacterial properties that make it effective as a topical application for acne treatment (Bingham et al, 2001). This compound is commonly utilized in the form of a 2.5% to 10% topical preparation for treatment of inflammatory acne, decubital and stasis ulcers, and pyoderma gangrenosum (HSDB , 2000).
    2) Benzoyl peroxide is used in industry as an oxidizing agent in the processes of bleaching flour, oils, waxes, and fats (Bingham et al, 2001; HSDB , 2000; Lewis, 1997; Budavari, 1996; ITI, 1995; Ashford, 1994; ACGIH, 1991; Sittig, 1991), and is used for drying unsaturated oils and in cheese manufacturing (HSDB , 2000; Lewis, 1997; ITI, 1995).
    3) This compound is employed as a polymerization initiator, a catalyst in the plastics industry, a curing agent for silicone rubbers and thermoset polyesters, a hardening catalyst for some fiberglass resins, and in vinyl flooring embossing (proprietary) (HSDB , 2000; Lewis, 1997; Budavari, 1996; ITI, 1995; Ashford, 1994; Kohler & Meyer, 1993; ACGIH, 1991).
    4) Benzoyl peroxide is utilized as a source of free radicals in organic synthesis, and is used in dental resin cement, for automobile body putty, in roof bolting, and in the mining industry (Bingham et al, 2001; HSDB , 2000; Budavari, 1996).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Benzoyl peroxide is commonly utilized as a 2.5% to 10% topical preparation for treatment of inflammatory acne, decubital and stasis ulcers, and pyoderma gangrenosum. Benzoyl peroxide is used in industry as an oxidizing agent, a polymerization initiator, a catalyst, and a curing agent. Benzoyl peroxide is utilized as a source of free radicals in organic synthesis, and is used in dental resin cement, for automobile body putty, in roof bolting, and in the mining industry.
    B) PHARMACOLOGY: Benzoyl peroxide has antimicrobial activity.
    C) TOXICOLOGY: Benzoyl peroxide is irritating to skin and mucous membranes. Allergic dermatitis may occur.
    D) EPIDEMIOLOGY: Overdose is rare and clinically significant toxicity has not been reported.
    E) WITH THERAPEUTIC USE
    1) Adverse effects include contact dermatitis, xeroderma, erythema, and skin peeling.
    F) WITH POISONING/EXPOSURE
    1) No overdoses resulting in significant toxicity have been reported.
    0.2.20) REPRODUCTIVE
    A) Benzoyl peroxide is classified as FDA pregnancy category C. There are no adequate and well-controlled studies of benzoyl peroxide use in pregnant women. It is not known if benzoyl peroxide is excreted in the breast milk.

Laboratory Monitoring

    A) The L929 mouse fibroblast cell line may exhibit similar benzoyl peroxide exposure characteristics as human eye fibroblasts. Thus the L929 cell line may have application for testing the cytotoxic vapor effects from benzoyl peroxide containing dental products.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Significant toxicity is not expected after benzoyl peroxide overdose.
    C) DECONTAMINATION
    1) Gastrointestinal decontamination is not indicated.
    D) AIRWAY MANAGEMENT
    1) Airway compromise is not expected in isolated benzoyl peroxide ingestions.
    E) ANTIDOTE
    1) None
    F) ENHANCED ELIMINATION
    1) Not indicated.
    G) PATIENT DISPOSITION
    1) HOME CRITERIA: Asymptomatic patients and patients with isolated skin irritation and erythema can be managed at home with observation.
    2) OBSERVATION CRITERIA; Patients with severe skin symptoms and non-skin symptoms, and patients with deliberate overdoses should be referred to a health care facility for observation and treatment.
    3) ADMISSION CRITERIA: Patients are not expected to develop toxicity requiring admission.
    4) CONSULT CRITERIA: Consult a poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    H) PITFALLS
    1) Missing an ingestion of another chemical or other possible etiologies for a patient’s symptoms.
    I) PHARMACOKINETICS
    1) Following application of a 10% preparation to excised human skin, 3% of the total dose was absorbed within 8 hours. Topically applied benzoyl peroxide is metabolized to benzoic acid within the skin.
    0.4.3) INHALATION EXPOSURE
    A) Move patient to fresh air. Monitor for respiratory distress. If cough or difficulty breathing develops, evaluate for respiratory tract irritation, bronchitis, or pneumonitis. Administer oxygen and assist ventilation as required. Treat bronchospasm with inhaled beta-2 agonist and oral or parenteral corticosteroids.
    0.4.4) EYE EXPOSURE
    A) Irrigate exposed eyes with copious amounts of room temperature water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist, the patient should be seen in a healthcare facility.
    0.4.5) DERMAL EXPOSURE
    A) OVERVIEW
    1) Remove contaminated clothing and wash exposed area extremely thoroughly with soap and water. A physician may need to examine the area if irritation or pain persists after washing.

Range Of Toxicity

    A) TOXICITY: Human exposure equal to or greater than 12.2 mg/m(3) produces nose and throat irritation.

Clinical Effects

Summary Of Exposure

    A) USES: Benzoyl peroxide is commonly utilized as a 2.5% to 10% topical preparation for treatment of inflammatory acne, decubital and stasis ulcers, and pyoderma gangrenosum. Benzoyl peroxide is used in industry as an oxidizing agent, a polymerization initiator, a catalyst, and a curing agent. Benzoyl peroxide is utilized as a source of free radicals in organic synthesis, and is used in dental resin cement, for automobile body putty, in roof bolting, and in the mining industry.
    B) PHARMACOLOGY: Benzoyl peroxide has antimicrobial activity.
    C) TOXICOLOGY: Benzoyl peroxide is irritating to skin and mucous membranes. Allergic dermatitis may occur.
    D) EPIDEMIOLOGY: Overdose is rare and clinically significant toxicity has not been reported.
    E) WITH THERAPEUTIC USE
    1) Adverse effects include contact dermatitis, xeroderma, erythema, and skin peeling.
    F) WITH POISONING/EXPOSURE
    1) No overdoses resulting in significant toxicity have been reported.

Heent

    3.4.5) NOSE
    A) WITH POISONING/EXPOSURE
    1) IRRITATION: Inhalation causes irritation of nose and throat.

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) DERMATITIS
    1) WITH THERAPEUTIC USE
    a) Moderate erythema, irritation and edema have followed topical exposure to 10% solutions (Morelli et al, 1989).
    B) GENERALIZED EXFOLIATIVE DERMATITIS
    1) WITH THERAPEUTIC USE
    a) Cutaneous side effects are greatest with benzoyl peroxide (5% gel) alone in the early weeks of treatment: erythema, peeling, dryness, burning, itching (Tucker et al, 1984).
    C) SEBORRHEA
    1) WITH THERAPEUTIC USE
    a) Benzoyl peroxide (2.5% to 10%) topically induces an increase in sebum excretion rate in the second month of treatment (Pierard-Franchimont et al, 1984).
    D) HYPERSENSITIVITY REACTION
    1) WITH THERAPEUTIC USE
    a) Skin contact causes primary irritation (Vasarinsh, 1968) and sensitization dermatitis (Fisher, 1989; van Joost et al, 1990). Benzoyl peroxide has been reported to be an allergen responsible for skin allergy in humans in approximately 1% to 2.5% of patients (Pace, 1965; Eaglestein, 1968).
    b) Patch test reactions in acne patients may be negative in patients allergic to benzoyl peroxide (Balato et al, 1984).
    c) Negative results may be explained by rapid degradation of benzoyl peroxide in patch test materials. Fresh preparations may be more likely to produce a positive result (Mora Morillas et al, 1987), or direct irritation.
    d) Dermatitis has also been reported in patients with prostheses that contained benzoyl peroxide as a catalyst (Vincenzi et al, 1991).
    2) WITH POISONING/EXPOSURE
    a) Allergic contact dermatitis may occur from airborne exposure, as in a church worker who was exposed via candles treated with benzoyl peroxide (Bonnekoh & Merk, 1991) and in an electrician who was sawing through insulation plastics, cables, and wires, and became exposed to benzoyl peroxide-treated plastic particles (Quirce et al, 1993).

Reproductive

    3.20.1) SUMMARY
    A) Benzoyl peroxide is classified as FDA pregnancy category C. There are no adequate and well-controlled studies of benzoyl peroxide use in pregnant women. It is not known if benzoyl peroxide is excreted in the breast milk.
    3.20.2) TERATOGENICITY
    A) ANIMAL STUDIES
    1) BENZOYL PEROXIDE/ADAPALENE: Rats treated with oral doses of adapalene 0.15 to 5 mg/kg/day, up to 25 times the maximum recommended human dose (MRHD) (mg/m(2)/day) of 2 g of adapalene/benzoyl peroxide gel showed no teratogenic effects. Teratogenic effects, such as cleft palate, microphthalmia, encephalocele, and skeletal abnormalities (in rats) and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities (in rabbits) were observed when treated with oral doses of adapalene (greater than or equal to 25 mg/kg/day), 123 and 246 times the MRHD. Rats and rabbits showed no fetotoxicity and minimal increases in supernumerary ribs, and delayed ossification (in rabbits) when treated with doses of adapalene 0.6 to 6 mg/kg/day (25 to 59 times (mg/m(2)) the MRHD in dermal teratology studies (Prod Info EPIDUO(R) topical gel, 2013).
    3.20.3) EFFECTS IN PREGNANCY
    A) LACK OF INFORMATION
    1) BENZOYL PEROXIDE: There are no adequate and well-controlled studies of benzoyl peroxide use in pregnant women. Until further data are available, it is recommended that benzoyl peroxide be administered to a pregnant woman only if the benefit to the mother justifies the risk to the fetus (Prod Info NEOBENZ(R) NEOBENZ(R)SD topical cream, topical cream, single dose, 2007).
    2) BENZOYL PEROXIDE/ADAPALENE: There are no adequate and well-controlled studies of benzoyl peroxide/adapalene use in pregnant women. Until further data are available, it is recommended that benzoyl peroxide/adapalene be administered to a pregnant woman only if the benefit to the mother justifies the risk to the fetus (Prod Info EPIDUO(R) topical gel, 2013).
    3) BENZOYL PEROXIDE/CLINDAMYCIN: There are no adequate or well-controlled studies of benzoyl peroxide/clindamycin phosphate use in pregnant women (Prod Info Acanya(R) topical gel, 2014).
    B) PREGNANCY CATEGORY
    1) The manufacturer has classified benzoyl peroxide, benzoyl peroxide/adapalene, and benzoyl peroxide/clindamycin as FDA pregnancy category C (Prod Info Acanya(R) topical gel, 2014; Prod Info EPIDUO(R) topical gel, 2013; Prod Info NEOBENZ(R) NEOBENZ(R)SD topical cream, topical cream, single dose, 2007).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) BREAST MILK
    1) It is unknown whether benzoyl peroxide, benzoyl peroxide/adapalene, or benzoyl peroxide/clindamycin is excreted in human milk after topical application. Exercise caution when administering this drug to a woman who is breastfeeding (Prod Info Acanya(R) topical gel, 2014; Prod Info EPIDUO(R) topical gel, 2013; Prod Info BENZOYL PEROXIDE GEL 2.5% 5% 10% topical gel, 2010).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS94-36-0 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) IARC Classification
    a) Listed as: Benzoyl peroxide
    b) Carcinogen Rating: 3
    1) The agent (mixture or exposure circumstance) is not classifiable as to its carcinogenicity to humans. This category is used most commonly for agents, mixtures and exposure circumstances for which the evidence of carcinogenicity is inadequate in humans and inadequate or limited in experimental animals. Exceptionally, agents (mixtures) for which the evidence of carcinogenicity is inadequate in humans but sufficient in experimental animals may be placed in this category when there is strong evidence that the mechanism of carcinogenicity in experimental animals does not operate in humans. Agents, mixtures and exposure circumstances that do not fall into any other group are also placed in this category.
    3.21.3) HUMAN STUDIES
    A) CARCINOMA
    1) Although benzoyl peroxide has been reported to be carcinogenic (Kurokawa et al, 1984) and co-carcinogenic (Slaga et al, 1981) other mutagenicity tests have been negative (Jackson, 1986). It may be a tumor promoter (Hogan, 1991; IARC, 1999).
    2) There have been two cases of lung cancer reported in persons working with BP and other substances (Sakabe & Fukuda, 1977).
    B) MELANOMA MALIGNANT
    1) CASE SERIES - A case-control study in 372 subjects showed no association between the use of topical benzoyl peroxide for acne and development of malignant melanoma (Cartwright et al, 1988).
    3.21.4) ANIMAL STUDIES
    A) CARCINOMA
    1) BP was an equivocal tumorigenic agent when applied to the skin of mice (RTECS, 1996). It was a strong promoter, enhancing the carcinogenicity of other substances (Kurokawa et al, 1984; Slaga et al, 1981; Iversen, 1986).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) The L929 mouse fibroblast cell line may exhibit similar benzoyl peroxide exposure characteristics as human eye fibroblasts. Thus the L929 cell line may have application for testing the cytotoxic vapor effects from benzoyl peroxide containing dental products.

Methods

    A) The effects of a 5 and 10 minute exposure to the vapor produced from a 10 microL aliquot of benzoyl peroxide was studied in the mouse fibroblast cell L929 line and human eye fibroblast cells. A linear decrease in cell viability was seen in both cell lines. Linear regression analysis revealed an r(2) = 0.99 and 0.94 for the mouse and human fibroblasts, respectively. The authors concluded that the mouse L929 line was as sensitive to benzoyl peroxide vapors as human eye tissue. Thus the mouse fibroblast could be a surrogate for testing the effects of benzol peroxide vapor toxicity on human eye tissue (Bester et al, 2003).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Patients are not expected to develop toxicity requiring admission.
    6.3.1.2) HOME CRITERIA/ORAL
    A) Asymptomatic patients and patients with isolated skin irritation and erythema can be managed at home with observation.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Consult a poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) Patients with severe skin symptoms and non-skin symptoms, and patients with deliberate overdoses should be referred to a health care facility for observation and treatment.

Monitoring

    A) The L929 mouse fibroblast cell line may exhibit similar benzoyl peroxide exposure characteristics as human eye fibroblasts. Thus the L929 cell line may have application for testing the cytotoxic vapor effects from benzoyl peroxide containing dental products.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) Gastrointestinal decontamination is not indicated. Wash exposed skin and irrigate exposed eyes.
    6.5.2) PREVENTION OF ABSORPTION
    A) Gastrointestinal decontamination is not indicated.
    6.5.3) TREATMENT
    A) SUPPORT
    1) Treatment is symptomatic and supportive. Significant toxicity is not expected after benzoyl peroxide overdose.

Inhalation Exposure

    6.7.1) DECONTAMINATION
    A) Move patient from the toxic environment to fresh air. Monitor for respiratory distress. If cough or difficulty in breathing develops, evaluate for hypoxia, respiratory tract irritation, bronchitis, or pneumonitis.
    B) OBSERVATION: Carefully observe patients with inhalation exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    C) INITIAL TREATMENT: Administer 100% humidified supplemental oxygen, perform endotracheal intubation and provide assisted ventilation as required. Administer inhaled beta-2 adrenergic agonists, if bronchospasm develops. Consider systemic corticosteroids in patients with significant bronchospasm (National Heart,Lung,and Blood Institute, 2007). Exposed skin and eyes should be flushed with copious amounts of water.

Eye Exposure

    6.8.1) DECONTAMINATION
    A) EYE IRRIGATION, ROUTINE: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, an ophthalmologic examination should be performed (Peate, 2007; Naradzay & Barish, 2006).

Dermal Exposure

    6.9.1) DECONTAMINATION
    A) DECONTAMINATION: Remove contaminated clothing and wash exposed area thoroughly with soap and water for 10 to 15 minutes. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).
    6.9.2) TREATMENT
    A) DERMATITIS
    1) Cool compresses may be of some benefit and there is a possible role for topical corticosteroids.
    B) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

Enhanced Elimination

    A) ENHANCED ELIMINATION
    1) Not indicated.

Range Of Toxicity

Summary

    A) TOXICITY: Human exposure equal to or greater than 12.2 mg/m(3) produces nose and throat irritation.

Minimum Lethal Exposure

    A) According to HSDB (2000), benzoyl peroxide has a potential minimum oral lethal dose of 0.5 to 5 g/kg or 1 ounce to 1 pint (or 1 pound) for a human weighing 70 kilograms (150 pounds) (HSDB , 2000).

Maximum Tolerated Exposure

    A) ADULT
    1) Human exposure equal to or greater than 12.2 mg/m(3) produced nose and throat irritation (ACGIH, 1991; Hathaway et al, 1996).
    2) The general population is most likely to be exposed to benzoyl peroxide by inhalation of benzoyl peroxide-containing products or through dermal contact with benzoyl peroxide-containing cosmetics. Occupational exposure is most likely through inhalation or dermal contact in industrial environments using or producing the chemical (HSDB , 2000).

Workplace Standards

    A) ACGIH TLV Values for CAS94-36-0 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Editor's Note: The listed values are recommendations or guidelines developed by ACGIH(R) to assist in the control of health hazards. They should only be used, interpreted and applied by individuals trained in industrial hygiene. Before applying these values, it is imperative to read the introduction to each section in the current TLVs(R) and BEI(R) Book and become familiar with the constraints and limitations to their use. Always consult the Documentation of the TLVs(R) and BEIs(R) before applying these recommendations and guidelines.
    a) Adopted Value
    1) Benzoyl peroxide
    a) TLV:
    1) TLV-TWA: 5 mg/m(3)
    2) TLV-STEL:
    3) TLV-Ceiling:
    b) Notations and Endnotes:
    1) Carcinogenicity Category: A4
    2) Codes: Not Listed
    3) Definitions:
    a) A4: Not Classifiable as a Human Carcinogen: Agents which cause concern that they could be carcinogenic for humans but which cannot be assessed conclusively because of a lack of data. In vitro or animal studies do not provide indications of carcinogenicity which are sufficient to classify the agent into one of the other categories.
    c) TLV Basis - Critical Effect(s): URT and skin irr
    d) Molecular Weight: 242.22
    1) For gases and vapors, to convert the TLV from ppm to mg/m(3):
    a) [(TLV in ppm)(gram molecular weight of substance)]/24.45
    2) For gases and vapors, to convert the TLV from mg/m(3) to ppm:
    a) [(TLV in mg/m(3))(24.45)]/gram molecular weight of substance
    e) Additional information:

    B) NIOSH REL and IDLH Values for CAS94-36-0 (National Institute for Occupational Safety and Health, 2007):
    1) Listed as: Benzoyl peroxide
    2) REL:
    a) TWA: 5 mg/m(3)
    b) STEL:
    c) Ceiling:
    d) Carcinogen Listing: (Not Listed) Not Listed
    e) Skin Designation: Not Listed
    f) Note(s):
    3) IDLH:
    a) IDLH: 1500 mg/m3
    b) Note(s): Not Listed

    C) Carcinogenicity Ratings for CAS94-36-0 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): A4 ; Listed as: Benzoyl peroxide
    a) A4 :Not Classifiable as a Human Carcinogen: Agents which cause concern that they could be carcinogenic for humans but which cannot be assessed conclusively because of a lack of data. In vitro or animal studies do not provide indications of carcinogenicity which are sufficient to classify the agent into one of the other categories.
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): 3 ; Listed as: Benzoyl peroxide
    a) 3 : The agent (mixture or exposure circumstance) is not classifiable as to its carcinogenicity to humans. This category is used most commonly for agents, mixtures and exposure circumstances for which the evidence of carcinogenicity is inadequate in humans and inadequate or limited in experimental animals. Exceptionally, agents (mixtures) for which the evidence of carcinogenicity is inadequate in humans but sufficient in experimental animals may be placed in this category when there is strong evidence that the mechanism of carcinogenicity in experimental animals does not operate in humans. Agents, mixtures and exposure circumstances that do not fall into any other group are also placed in this category.
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed ; Listed as: Benzoyl peroxide
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS94-36-0 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Listed as: Benzoyl peroxide
    2) Table Z-1 for Benzoyl peroxide:
    a) 8-hour TWA:
    1) ppm:
    a) Parts of vapor or gas per million parts of contaminated air by volume at 25 degrees C and 760 torr.
    2) mg/m3: 5
    a) Milligrams of substances per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is approximate.
    3) Ceiling Value:
    4) Skin Designation: No
    5) Notation(s): Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) References: Clayton & Clayton, 1993 HSDB, 2000 ITI, 1995 Lewis, 1996 RTECS, 2002
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) 250 mg/kg
    b) 206-242 mg/kg
    2) LD50- (ORAL)MOUSE:
    a) 5700 mg/kg
    3) LD50- (ORAL)RAT:
    a) 7710 mg/kg; respiratory cyanosis, other changes in urine composition and liver

Pharmacology Toxicology

Pharmacologic Mechanism

    A) MECHANISM OF ACTION -
    1) Benzoyl peroxide enhances aggregation of human platelets. This is not inhibited by indomethacin (Gwebu et al, 1983).
    2) Vitamin E, propyl gallate and alpha naphthol inhibit the platelet aggregation induced by benzoyl peroxide (Gwebu et al, 1983).
    3) Benzoyl peroxide also has an antibacterial effect secondary to slow release of oxygen, as well as keratolytic, drying, and desquamative effects.

Physicochemical

Physical Characteristics

    A) Benzoyl peroxide exists as a white, granular, crystalline solid which is soluble in acetone, chloroform, and ether, and sparingly soluble in water and alcohol (Prod Info Benzamycin(R) Pak topical gel, 2006; Prod Info BENZAMYCIN(R) topical gel, 2008; CHRIS, 2005; Bingham et al, 2001; ITI, 1995; Lewis, 2000; Sittig, 1991). It is tasteless (ITI, 1995; Lewis, 2000) and has been described both as having a slightly bitter odor similar to almonds (Bingham et al, 2001; ITI, 1995) and as being odorless (CHRIS, 2005; Lewis, 2000).

Molecular Weight

    A) 242.23 (Prod Info Benzamycin(R) Pak topical gel, 2006; Prod Info BENZAMYCIN(R) topical gel, 2008)

Other

    A) ODOR THRESHOLD
    1) Odorless (CHRIS, 2005)

References

General Bibliography

    1) 40 CFR 372.28: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Lower thresholds for chemicals of special concern. National Archives and Records Administration (NARA) and the Government Printing Office (GPO). Washington, DC. Final rules current as of Apr 3, 2006.
    2) 40 CFR 372.65: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Chemicals and Chemical Categories to which this part applies. National Archives and Records Association (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Apr 3, 2006.
    3) 49 CFR 172.101 - App. B: Department of Transportation - Table of Hazardous Materials, Appendix B: List of Marine Pollutants. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Aug 29, 2005.
    4) 49 CFR 172.101: Department of Transportation - Table of Hazardous Materials. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Aug 11, 2005.
    5) 62 FR 58840: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 1997.
    6) 65 FR 14186: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.
    7) 65 FR 39264: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.
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