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EC number: 407-950-9 | CAS number: 895-85-2 INTEROX-PMBP-70W; INTEROX-PMPB-70W
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 days of treatment and observation ( September 9, 1991 to September 12, 1991)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A reliability rating of K2 was given due to minor deficiencies such as the lack of inclusion of CAS number and the Certificate of Analysis of the test material in the Study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(4-methylbenzoyl)peroxide
- EC Number:
- 407-950-9
- EC Name:
- Bis(4-methylbenzoyl)peroxide
- Cas Number:
- 895-85-2
- Molecular formula:
- C16H14O4
- IUPAC Name:
- 4-methylbenzoyl 4-methylbenzene-1-carboperoxoate
- Test material form:
- other: Solid White
- Details on test material:
- - Name of test material (as cited in study report): Di-(4-Methylbenzoyl)-peroxid (INTEROX-PMBP)
- Physical state: solid, white
- Analytical purity: Water damped powder 72% PMBP
- Purity test date: Not provided
- Batch No.: IR 240001
- Stability of test article: Stable
-Expiration date: November, 1991
- Stability of test article dilution: Stable in water for at least 48 hours
- Storage condition of test material: In the original container; protected from light at room temperature (approx. 20 degrees C)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- IN-LIFE DATES:
Acclimatization: September 5 to 8, 1991
Treatment/Observation: September 9 to 12, 1991
Completion: September 12, 1991
Reported: October 16, 1991
Test System: Rabbit, ChbbIbm: NZW (SPF)
Rationale: Recognized by the international guidelines as the recommended test system (e.g. OECD, EEC).
Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414, Fullinsdorf
Number of animals: 1 male, 2 females
Age at start of treatment: male: 15 weeks; females: 16 weeks
Body weight at start of treatment: male: 2.8 kg; females: 2.8 kg
Identification: By unique cage number and corresponding ear tags.
Acclimatization: Four days under test conditions after veterinary examination.
Allocation: Animal Numbers, Male no. 34, and Female nos. 35 – 36
Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour and hourly monitored environment with a temperature of 20±3 degrees centigrade, a relative humidity between 40-70% (values above 70% during cleaning process possible), 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark, music during the light period.
Accommodation
Individually, in stainless steel cages (size: 35.5 x 55.5 x 45 cm) equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, 0-7830 Emmendingen).
Diet
Pelleted standard Kliba 341, Batch 63/91 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum. Results of analysis for contaminants are included in the original study report.
Water
Community tap water from Itingen, ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the original Study report.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
0.5 g of the test article was applied to approx. 6 sq. cm of the intact skin.
VEHICLE
The test article was applied moistened with bi-distilled water. The vehicle used, was found to be the most qualified to assure an optimum
technical application procedure of the test article. - Duration of treatment / exposure:
- 4 hrs
- Number of animals:
- three
- Details on study design:
- Rationale: Skin contact is one of the probable routes of human exposure.
Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration. Only those animals with no signs of skin injury or irritation were used in the test.
On test day 1, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm-tap water.
Viability/Mortality and Clinical Signs : Observed dail y.
(Viability/mortality was recorded together with clinical signs on-line at the same time intervals. It is not specifically indicated in the computer system.)
Body Weights: At the start of acclimatization, day 1 of test (application day) and at termination of observation.
Irritation Scores: Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the following numerical scoring system. (See under "other information on materials and methods" Section.) The skin reaction was assessed at 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article. The corrosive properties of the test article and the staining of the treated skin area related to the test article were described and recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (#34, male)
- Time point:
- other: 1 hr
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Well defined erythema and slight edema, whole area
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (#34, male)
- Time point:
- other: 1 hr
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (#35, female)
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Very slight erythema, edema, whole area
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (#35, female)
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (#36, female)
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Very slight erythema, edema, whole area
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (#36, female)
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Very slight erythema, maculated
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No abnormalities visible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Very slight erythema, edema, maculated
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No abnormalities visible.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No abnormalities visible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Very slight erythema, maculated
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Zero score for all 3 animals at 48 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (#34, male)
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No abnormalities visible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (#35, female)
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No abnormalities visible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (#36, female)
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No abnormalities visible
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Zero score for all 3 animals at 72 hrs
- Irritant / corrosive response data:
- RESULTS
IRRITATION: Di-(4-Methylbenzoyl)-peroxid (INTEROX PMBP) showed a primary irritation score of 0.44 when applied to healthy intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.58 erythema and grade 0.42 edema.
COLORATION: In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.
CORROSION: No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. - Other effects:
- CLINICAL SIGNS AND VIABILITY I MORTALITY: No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred.
BODY WEIGHTS: The body weight gain of all rabbits was similar.
Any other information on results incl. tables
The individual skin irritation scores at 1, 24, 48 and 72 hrs as well as the calculated mean scores for each animal based on 24, 48 and 72 hour observations are provided as two tables under "overall remarks, attachments" (see illustration).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article Di-(4 -Methy1benzoy1)-peroxid (INTEROX PMBP) is classified as not irritant to the skin of rabbits based on the EEC Council Directive,83/467/EEC,July 1983 and67/548/EEC, May 1987, Brussels, Belgium.
- Executive summary:
The purpose of this primary skin irritation study was to assess the possible irritation potential when single doses of Di-(4 -Methy1benzoy1)-peroxid (INTEROX PMBP) were placed (semi-occlusive) on the skin of NZW rabbits. This study should provide a rational basis for risk assessment in man. The GLP study was conducted according to OECD 404 and EEC B4 test guidelines. A reliability rating of K2 was given due to minor deficiencies such as the lack of inclusion of CAS number and the Certificate of Analysis of the test material in the Study report.
Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.58 erythema and grade 0.42 edema. In the area of application, no staining of the treated skin by pigment or coloring of the test article was observed. No corrosive effect occurred on the treated skin of any animal at each measuring interval. Under the conditions of this experiment, Di-(4-Methylbenzoyl)-peroxid (INTEROX PMBP) was found to cause a primary irritation score of 0.44 when applied to healthy intact rabbit skin.
According to EEC Council Directive, 83/467/EEC, July 1983 and 67/548/EEC, May 1987, Brussels, Belgium, the mean value of the scores for each type of lesion, calculated for each animal separately, is the following:
AnimalNo. / Sex Mean 24 - 72 hours
Erythema Edema
34 M 0.33 0.00
35 F 0.00 0.00
36 F 0.67 0.33
Conclusion: Based on the results described above, the test article Di-(4 -Methy1benzoy1)-peroxid (INTEROX PMBP) is classified as not irritant to the skin of NZW rabbits.
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