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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US FDA, 21 CFR, Part 191, Hazardous substances test for eye irritants
- Deviations:
- yes
- Remarks:
- Few data on experimental conditions and no individual animal data reported
- GLP compliance:
- not specified
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
- Test material form:
- other: granules
- Details on test material:
- Benzoyl peroxide, purity = 78 percent, white granules
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2563-3217 grams
- Diet and Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye served as the untreated control for each rabbit.
- Amount / concentration applied:
- Dosed used : 0.1 ml of test material was instilled into the everted lower eye lid of one eye of each rabbit.
The average weight of the test material was 111.4 (group I, 5 minute wash) and 120.7 mg (group II, 24 hours wash). - Duration of treatment / exposure:
- Rinced after 5 min (Group I) and not rinced (Group II)
- Observation period (in vivo):
- Observation period : Eyes were examined at 1, 24, 48, 72 hours and 7 days after washing. 14 and 21 day examination were precluded by the absence of ulceration or opacity at 7 days.
- Number of animals or in vitro replicates:
- 5 rabbits in Group I (5-min exposure) and 3 rabbits in Group II (24-hour exposure).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes, following the exposur period, with a continuous stream of water over a 2 minute period.
- Time after start of exposure: 5 min ou 24 hours
SCORING SYSTEM: OECD grading
Examination were perfored 1 hour following was, then at 24 hours, 48 hours, 72 hours, 7 days, 14 days and 21 days.
TOOL USED TO ASSESS SCORE: fluorescein. The fluorescein was not used in the group 1 for examination at 48 hours and in the group 2 for scoring 1 hour and 48 hours after exposure.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: not rinced
- Irritation parameter:
- iris score
- Basis:
- animal: #1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: not rinced
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- for the 3 animals together
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: not rinced
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- for the 3 animals together
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: not rinced
- Irritant / corrosive response data:
- Group I : benzoyl peroxide produced very minor redness (conjunctivitis) and swelling (chemosis) in 1/5 and 2/5 rabbits, respectively, but it was clear in 24 hours. No corneal opacity was observed.
Group II : there was grade 1 opacity in 3/3 at 24 hours but it was clear at 48 hours. No iritis. There was grade 2 redness in 2/3 at 48 hours, degrading to grade 1 in 1/3 at 72 hours ; clear by day 7.
Any other information on results incl. tables
GROUP 1 (5 min wash):
-Cornea: no ulceration or opacity: at 1, 24, 48, 72 hours and 7 days for all the animals (5/5)
-Normal iris: at 1, 24, 48, 72 hours and 7 days: 5/5
-Conjunctivae: vessels normal at 1 and 24 hours: 4/5 (grade 1 for 1/5); and at 48, 72 hours and 7 days: normal for 5/5
-Chemosis: at 1 hour: 2/5 with no swelling, 2/5 with grade 1 and 1/5 with grade 2; at 24, 48,72 hours, and 7 days: no swelling for 5/5
GROUP 2 (24 hours wash):
-Cornea: no ulceration or no opacity for 3/3 at 1, 48 and 72 hours, grade 1 at 24 hours for 3/3 animals
- Iris: normal for all animals for all time observation
-Conjunctivae : redness
- at 1 hour and 24 hours: grade 1 for 1/3 and grade 2 for 2/3
- at 48 hours: grade 1 for 2/3 and grade 2 for 1/3
- at 72 hours: vessels normal for 2/3 and grade 1 for 1/3
- at 7 days: vessels normal for 3/3
-Chemosis:
- at 1 hour: grade 1 for 1/3 and grade 2 for 2/3
- at 24 hours: grade 1 for 1/3, grade 2 for 1/3 and grade 3 for 1/3
- at 48 hours: no swelling for 1/3, grade 1 for 1/3 and grade 1 for 1/3
- at 72 hours: grade 1 for for 1/3 and grade 2 for 2/3
-
at 7 days: no swelling for 3/3 Fluorescein examination:
3/3 positive damage at 24 hours, 1/3 at 48 hours and 0/3 after 7 days
Blanching of the conjunctival tissue was observed for one animal only
after one hour.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Benzoyl peroxide was neither irritating not corrosive to the eyes of albino rabbits if it was washed out within 5 minutes, but if 78 % benzoyl peroxide was not washed out until 24 hours later, it proved to be moderately irritating to rabbit eyes. It was not considered corrosive because corneal opacity lasted less than 6 days. Moreover, all the signs were reversible for 7 days.
- Executive summary:
The potential of dibenzoyl peroxide to induce ocular irritation was evaluated in rabbits according to a method similar to OECD (No. 405, 24th April 2002) guideline.
A single dose of 0.1 mL of dibenzoyl peroxide (purity, 78 %) was instilled into the right conjunctival sac. The left eye was not treated and served as control.The substance was administered to 5 New Zealand White rabbits for 5 minutes, then the eye was washed. Moreover, the substance was adminstered to 3 New Zealand White rabbits for 24 hours, the eye was not washed.
Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours and 7 days after the administration of the substance. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were not calculated for each animal, but global scores for these effects were reported.
In group 1 (duration exposure: 5 minutes), benzoyl peroxide produced very minor redness (conjunctivitis) and swelling (chemosis) in 1/5 and 2/5 rabbits, respectively, but it was clear in 24 hours. No corneal opacity was observed.
In group 2 (duration exposure: 24 hours), there was grade 1 opacity in 3/3 rabbits at 24 hours ; clear in 3/3 at 48 hours. No iritis was observed. There was grade 2 redness in 2/3 at 48 hours, degrading to grade 1 in 1/3 at 72 hours ; clear by day 7. Even a clear irritative response was observed, all the signs were reversible within 7 days.
At fluorescein examination, corneal damage was observed in all animals after 24 hours, in one animal after 72 hours, and in no animal after 7 days.
Under these experimental conditions, the test item was moderately irritant when administered by ocular route to rabbits.
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