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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 218-664-7 | CAS number: 2212-81-9
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20120-03-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-conducted and document study performed under GLP to current guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- yes
- Remarks:
- No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [1,3-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide
- EC Number:
- 218-664-7
- EC Name:
- [1,3-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide
- Cas Number:
- 2212-81-9
- Molecular formula:
- C20H34O4
- IUPAC Name:
- 1,3-bis[2-(tert-butylperoxy)propan-2-yl]benzene
- Test material form:
- solid: flakes
Constituent 1
Test animals / tissue source
- Species:
- other: cow
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- other: mineral oil
- Controls:
- other: see above
- Amount / concentration applied:
- 0.75 ml of a 20% w/v solution of test material in mineral oil
- Duration of treatment / exposure:
- 240 minutes
- Observation period (in vivo):
- none
- Number of animals or in vitro replicates:
- Twelve corneas were used; three for the test material, three for the negative control, three for the positive control and three for the vehicle control.
- Details on study design:
- Source of Bovine Eyes
Eyes from adult cattle were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee and placed in Hanks' Balanced Salt Solution (HBSS), supplemented with Penicillin/Streptomycin, and transported to the laboratory on ice packs. The eyes were refrigerated on arrival and used within 24 hours of receipt. All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
Preparation of Corneas
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed (epithelial side uppermost) in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders. The anterior and posterior chambers of each BCOP holder were filled with complete minimum essential medium (MEM) and plugged. The holders were incubated at 32 ±1°C for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
Selection of Corneas and Opacity Reading
The medium from both chambers of each holder was replaced with fresh complete MEM. A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer. The average opacity for all corneas was calculated. Three corneas were numerically allocated to the test item formulation. Three corneas were also numerically allocated to the negative control item, three corneas to the positive control item and three corneas to the mineral oil control.
Treatment of Corneas
The MEM was removed from the anterior chamber of the BCOP holder and 0.75 mL of the test item at a concentration of 20% w/v in mineral oil or control items were applied to the cornea. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1°C for 240 minutes.
At the end of the exposure period the test item formulation and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM. Due to the limited solubility in the MEM rinsing solutions, the corneas treated with the mineral oil and the corneas treated with the test item in mineral oil were initially swabbed with 1 % Tween 80 before rinsing with MEM.
The anterior chamber was refilled with fresh complete MEM. A post-treatment opacity reading was taken and each cornea was visually observed.
Application of Sodium Fluorescein and Permeability Determinations
Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (5 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ±1°C for 90 minutes.
After incubation the medium in the posterior chamber of each holder was decanted and retained. 360 µL of medium representing each cornea was applied to a designated well on a 96-well plate and the optical density at 492nm (00492) was measured. If values greater than 1.500 00492 were obtained a 1 in 5 dilution of the medium in complete MEM was performed and the measurement repeated. The modified value was multiplied by 5 to reflect the 1 in 5 dilution.
Histopathology
The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labelled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- Treatment In Vitro Irritancy Score
Test Item 20% w/v in Mineral Oil 0.7
Negative Control 6.1
Positive Control 103.6
Mineral Oil 3.3
Any other information on results incl. tables
Corneal Epithelium Condition Post Treatment
Treatment | Cornea Number | Observation Post Treatment |
Negative Control | 1 | clear |
|
2 |
clear |
3 |
clear |
|
Positive Control |
4 |
cloudy |
|
5 |
cloudy |
|
6 |
cloudy |
Mineral Oil |
7 |
clear |
|
8 |
clear |
|
9 |
clear |
Test Item 20% w/v in Mineral Oil |
10 |
clear |
|
11 |
clear |
|
12 |
clear |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item at a concentration of 20% w/v in mineral oil was considered not to be an ocular corrosive or severe irritant.
- Executive summary:
A study was performed to assess the ocular irritancy potential of the test item to the isolated bovine cornea. The method was designed to be compatible with OECD Guidelines for the Testing of Chemicals No. 437 (2009) "Bovine Corneal Opacity and Permeability Assay" Method.
The test item was applied at a concentration of 20% w/v in mineral oil for 240 minutes. Negative, positive and mineral oil control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
The in vitro Irritancy scores are summarised as follows:
Treatment
In Vitro Irritancy Score
Test Item 20% w/v in Mineral Oil
0.7
Negative Control
6.1
Positive Control
103.6
Mineral Oil Control
3.3
The test item at a concentration of 20% w/v in mineral oil was considered not to be an ocular corrosive or severe irritant.
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.