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EC number: 202-327-6 | CAS number: 94-36-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limitations in the design and reporting of the study. Howevet, it was considered and evaluated by WHO/JEFCA (Kroes et al., 2006) for the toxicological assessment of benzoyl peroxide as food additive.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Study of the Biological Effects of benzoyl Peroxide
- Author:
- Sharratt M, Frazer AC and Forbes OC
- Year:
- 1 964
- Bibliographic source:
- Fd. Cosmet. Toxicol., 2:527- 538
- Reference Type:
- secondary source
- Title:
- BENZOYL PEROXIDE. Safety evaluation of certain food additives / prepared by the sixty-third meeting of the Joint FAO/WHO Expert Committee on Food Additives (JEFCA).
- Author:
- Kroes R, DiNovi M and Bend JR
- Year:
- 2 006
- Bibliographic source:
- WHO food additives series, 54:17-35. World Health Organization, Geneva [https://extranet.who.int/iris/restricted/bitstream/10665/43265/1/9241660546_eng.pdf]
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Feeding toxicity and carcinogenicity study
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Dibenzoyl peroxide
- EC Number:
- 202-327-6
- EC Name:
- Dibenzoyl peroxide
- Cas Number:
- 94-36-0
- Molecular formula:
- C14H10O4
- IUPAC Name:
- diphenylperoxyanhydride
- Details on test material:
- Novaldelox (commercial powder containing 18 percent Benzoyl peroxide)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Diet composition: 100% whole meal flour, 56; dried skimmed milk, 20; fish meal, 11; alfalfa meal, 2; dried yeast and yeast extract, 1 each; cod liver oil, 3; salt mixture, 4. The remaining 2% was a triturate in whole meal flour of benzoyl peroxide added in the form of Novadelox, a commercial powder containing 18% benzoyl peroxide, 78% calcium sulphate and 4% magnesium carbonate.
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 120 weeks
- Frequency of treatment:
- ad libitum
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.0157, 0.157 and 1.57 % of Novadelox in diet
Basis:
other: nominal in diet (groups F3, F2 and F1, respectively)
- Remarks:
- Doses / Concentrations:
28, 280, 2,800 mg BPO/kg diet
Basis:
other: nominal in diet (groups F3, F2 and F1, respectively)
- Remarks:
- Doses / Concentrations:
Male: 1.9, 19 or 190 mg/kg bw/d
Basis:
other: actual ingested, calculation (Kroes et al., 2006)
- Remarks:
- Doses / Concentrations:
Female: 2.3, 23 and 230 mg/kg bw/d
Basis:
other: actual ingested, calculation (Kroes et al., 2006)
- No. of animals per sex per dose:
- 25
- Control animals:
- other: yes, concurrent no treatment (FC group)
Examinations
- Observations and examinations performed and frequency:
- Body wt gains of rats were noted weekly for 18 weeks, and then monthly. The animals were examined twice daily with regard to their general health
- Sacrifice and pathology:
- Animals that were moribund were killed. All animals that were killed or that died were autopsied. Benign and malignant tumours were analysed.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Some statistically significant differences were found between the mortality rates of control and experimental groups, but the importance of these findings is doubtful. The mortality of female rats fed on diet F2 was greater than the controls (group FC) at 78 weeks, whereas before and after this period no significant difference was found. There was no increased mortality in males receiving this diet or in males and females receiving the diet containing a higher concentration of Novadelox.
BODY WEIGHT AND WEIGHT GAIN
The rate of body weight gain was depressed (<10%), in several cases to a significant extent, in male and female rats consuming the flour diets containing the two highest levels of Novadelox. The effect, which was most noticeable during the first 8 months with diet F1, could have been due to (1) a diminished acceptability of the diet to rats, (2) a marginal nutritional deficiency caused by the action of benzoyl peroxide on flour, or to (3) the toxic action of Novadelox or its reaction products.
HISTOPATHOLOGY: NON-NEOPLASTIC
Many and varied gross and microscopic changes were found in all groups. Except for testicular atrophy, pathological abnormalities occurred to an equal extent in experimental and control animals or, because of a low incidence, occurred randomly in control or experimental groups. Infective changes were common, particularly in the lungs of both sexes of rat, and in the uterus of female rats. More than one lesion caused by infection was found per animal in rats. Local vascular damage frequently accompanied infective lesions. Degenerative changes were found most frequently in the liver, kidney, testes and adrenals of rats. Ulceration of the stomach was not found in control rats, while it occurred in 2 of the 96 examined which received the highest dosage level of benzoyl peroxide in flour diet.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
The overall tumour incidence was not significantly different between the experimental and control groups in rats. Most tumoun were found in rats which were examined after 100 weeks treatment, the occurrence being low before that time.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 19 - 23 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect at this dose level
- Dose descriptor:
- NOAEL
- Effect level:
- 190 - 230 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- histopathology: non-neoplastic
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Sharratt et al. (1964) conducted a study on the treatment of whole meal flour with benzoyl peroxide. Albino rats (groups of 25 animals/sex/ species; strain and age were unspecified) were fed a diet with increasing amount of Novadelox, a commercial powder containing 18% benzoyl peroxide (purity unspecified). Control groups received a diet lacking Novadelox. According to the authors, treatment groups received 10, 100 or 1,000 times the daily intake, for 120 weeks. The estimated doses of benzoyl peroxide amounted to 28, 280 and 2,800 mg/kg diet (equal to approximately 1.9, 19 or 190 mg/kg bw for males, and 2.3, 23 and 230 mg/kg bw for females). Body weight gain was depressed in male and female rats consuming the diets containing the highest levels of benzoyl peroxide. The authors speculated that these weight depressions of about 10% were caused by marginal nutritional deficiencies, because an increased intake of food reversed the phenomenon. A part from the 280 mg/kg diet group, in which there was a large number of accidental deaths, there was no significant difference between experimental and appropriate control groups in the mortality rate of the animals. Testicular atrophy was increased at the highest concentratrion. The authors suggested that this atrophy was caused by benzoyl peroxide, which probably marginally decreased the amount of vitamin E in the diet. No evidence for benzoyl peroxide-related carcinogenicity was observed. Based on the limited and/or indirect effects observed, the highest concentration of 2,800 mg/kg diet, equivalent to ca. 200 mg/kg bw/day, can be considered as the NOAEL.
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