Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 72 hours (treatment/observation: October 1, 1991 to October 4, 1991).
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A reliability rating of K2 was given due to minor deficiencies e.g., non-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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Di-(4-Methylbenzoyl)-peroxid (INTEROX PMBP)
- IUPAC Name:
- Di-(4-Methylbenzoyl)-peroxid (INTEROX PMBP)
- 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
- Storage condition of test material: In the original container; protected from light at room temperature (approx. 20 degrees C)
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- IN-LIFE DATES:
Acclimatization: September 27 to 30, 1991
Treatment/Observation: October 1 to 4, 1991
Termination: October 4, 1991
Reported: October 24, 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: 2.9 kg; females: 2.9 - 3.0 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 analysisfor 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of each animal remained untreated and served as the reference control
- Amount / concentration applied:
- 0.1 g of the test article (undiluted)
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Rationale: Ocular contact is one of the probable routes of human exposure.
TREATMENT: The eyes of the animals were examined once, one day prior to test article administration. Only those animals with no signs of ocular injury or irritation were used on the test. On test day 1, 0.1 g of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission Washington, D.C. 20207 was used for additional control purposes.
Viability/Mortality and Clinical Signs**: Daily.
Body Weights: At the start of acclimatization, at day 1 of test (application day) and at termination of observation.
** Viability/mortality was recorded together with clinical signs on-line at the
same time intervals. It is not specifically indicated in the computer system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- (Mean)
- Basis:
- mean
- Remarks:
- of animals # 34M, 35F & 36F
- Time point:
- other: 1 hr
- Score:
- 1.67
- Irritation parameter:
- overall irritation score
- Remarks:
- (Mean)
- Basis:
- mean
- Remarks:
- of animals # 34M, 35F & 36F
- Time point:
- other: 24 hrs
- Score:
- 0.67
- Irritation parameter:
- overall irritation score
- Remarks:
- (Mean)
- Basis:
- mean
- Remarks:
- of animals # 34M, 35F & 36F
- Time point:
- other: 48 hrs
- Score:
- 0
- Irritation parameter:
- overall irritation score
- Remarks:
- (Mean)
- Basis:
- mean
- Remarks:
- of animals # 34M, 35F & 36F
- Time point:
- other: 72 hrs
- Score:
- 0
Any other information on results incl. tables
RESULTS
VIABILITY / MORTALITY AND CLINICAL SIGNS:
No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred.
IRRITATION:
Di-(4-Methylbenzoyl)-peroxid (INTEROX-PMBP) showed a primary irritation score
of 0.58, when applied to the conjunctival sac of the rabbit eye.
COLORATION:
In the area of application no staining of the cornea and conjunctivae by pigment or coloring of the test article was observed.
CORROSION:
Generally slightly diffuse corneal opacity was observed in one animal (female
no. 36) in the first hour after test article application.
BODY WEIGHTS:
The body weight gain of all rabbits was similar.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article, Di-(4-Methy1benzoyl)-peroxid (INTEROX-PMBP), had to be classified as not irritant to the rabbit eye.
- Executive summary:
SUMMARY
The purpose of this primary eye irritation study was to assess the possible irritation potential when a single dose of Di-(4-Methylbenzoy1)-peroxid (INTEROX-PMBP) was placed in the conjunctival sac of NZW rabbit eyes. This study should provide a rational basis for risk assessment in man. This GLP study was conducted according to OECD 405 and EEC B5 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.
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:
Animal Mean values 24 - 72 hours
No. Cornea Iris Conjunctivae
opacity Redness Chemosis
34 M 0.00 0.00 0.33 0.00
35 F 0.00 0.00 0.00 0.00
36 F 0.00 0.00 0.33 0.00
Mean cumulative score: 0.22; Primary irritation score: 0.58 (mean of 24, 48, and 72 hr scores)
Under the conditions of this GLP-certified experiment, Di-(4-Methylbenzoyl)-peroxid was found to cause a primary irritation score of: 0.58 when applied to the conjunctival sac of the rabbit eye. No staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed. Generally slightly diffuse corneal opacity was observed in one animal (female animal No. 36) in the first hour after test article application. Body weight gain of all rabbits was similar.
Conclusion: Due to the results described above, the test article (Di-(4-Methy1benzoyl)-peroxid (INTEROX-PMBP) had to be classified as not irritant to the rabbit eye.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.