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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 944-271-1 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
An in vitro skin corrosion study and an ex vivo eye irritation/corrosion study were conducted with DiBrORMA. The results of the studies were:
Not irritation when tested according to OECD 437.
Not corrosive when tested according to OECD 431.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Batch: 653940
- Purity, including information on contaminants, isomers, etc.: No data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: No data
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No data
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No data
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): test article solubilized in tissue culture water
- Preliminary purification step (if any): No data
- Final concentration of a dissolved solid, stock liquid or gel: No data
FORM AS APPLIED IN THE TEST: test article solubilized in tissue culture water - Test system:
- human skin model
- Remarks:
- MatTek EpiDerm™ tissues
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: No data
- Justification for test system used:
- Per OECD 431.
- Vehicle:
- other: See 'Remarks'
- Remarks:
- Tissue culture water
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: EpiDerm™ tissues, Lot No. 27144 Kit O, were received from MatTek Corporation (Ashland, MA) on
03 Oct 2017 and refrigerated at 2-8°C. Before use, tissues were incubated (37±1°C, 5±1% CO2) with
assay medium (MatTek) for a one-hour equilibration. Equilibration medium was replaced with fresh
medium before dosing.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37C
- Temperature of post-treatment incubation (if applicable): No data
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Following exposure to test materials, any test material remaining atop the EpiDerm™ tissues will be discarded. Each insert will be individually rinsed extensively with phosphate buffered saline (PBS) to remove residual test material. For a test article in which the tissue or assay medium undergoes a noticeable color change (due to pH change, staining of the tissue, etc.), an extra rinsing procedure will be performed before the MTT conversion. The tissues will be submerged twice in fresh PBS and then incubated in PBS at room temperature for 3 minutes.
- Observable damage in the tissue due to washing: No data
- Modifications to validated SOP: No data
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: visible range
- Wavelength: 540 to 570 nm
- Filter: No data
- Filter bandwidth: No data
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the mean viability at 3 min is greater than 50% or if the mean viability is less than or equal to 50% at 3 min but the mean viability at 60 min is greater than 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 uL
- Duration of treatment / exposure:
- 3 or 60 minutes
- Duration of post-treatment incubation (if applicable):
- None
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minutes
- Value:
- 95.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Remarks on result:
- other:
- Remarks:
- Non-corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minutes
- Value:
- 91.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Remarks on result:
- other:
- Remarks:
- Non-corrosive
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: None
- Colour interference with MTT: None detected
DEMONSTRATION OF TECHNICAL PROFICIENCY: The CRO running the study is techincally proficient in running OECD 439 with MatTek tissues.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
- Range of historical values if different from the ones specified in the test guideline: Per OECD 431 and MatTek protocol. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The percent viability was 95.5% at 3 minutes and 91.9% at 60 minutes. The test article was non-corrosive.
- Executive summary:
DiBrorma was tested in a GLP-compliant, OECD 431EpiDerm™ Skin Corrosivity Test.MatTek EpiDerm™ tissues were treated in duplicate with the test article, negative control, tissue culture water, and positive control, potassium hydroxide solution, for 3 minutes and 60 minutes. Following treatment, the viability of the tissues was determined using thiazolyl blue tetrazolium bromide (MTT) uptake and conversion, and the absorbance of each tissue was measured at 540 nm. The mean viability was then expressed as a percent of control values. The percent viability was used to determine corrosivity potential. The percent viability was 95.5% at 3 minutes and 91.9% at 60 minutes. The test article was non-corrosive.
Reference
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: SHBH4983V
- Purity, including information on contaminants, isomers, etc.: No data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: Stable for the duration of the study.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No data.
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No data.
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No data.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): 100% ethanol for liquid test articles, and imidazole (20%
solution in 0.9% saline) for powder or solid test articles.
- Preliminary purification step (if any): None. - Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Cattle
- Number of animals: 12 corneas.
- Characteristics of donor animals (e.g. age, sex, weight): at least six months old.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Bovine eyes (at least six months old) will be obtained from an abattoir and will be
transported to the laboratory containing Hanks’ Balanced Salt solution Hanks’
Balanced Salt Solution (HBSS) and penicillin-streptomycin in a refrigerated container.
- Time interval prior to initiating testing: No data.
- Indication of any existing defects or lesions in ocular tissue samples: The eyes will be examined after receipt from the abattoir. Any eye with a cornea
exhibiting evidence of vascularization, pigmentation, opacity or scratches will be
discarded. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit) :0.75 ml
- Concentration (if solution): 10% w/v or v/v in 0.9%
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- All corneas will be incubated at 32 (±1)°C until immediately prior to the two hour scores, at which time the MEM solution in the anterior and posterior
chambers will be removed and the holders refilled with fresh MEM solution. - Number of animals or in vitro replicates:
- 12
- Details on study design:
- NUMBER OF REPLICATES
: 3 corneas per group
NEGATIVE CONTROL USED : Minimal Essential Media (MEM)
SOLVENT CONTROL USED (if applicable) : MEM solution with phenol red
POSITIVE CONTROL USED : Ethanol
APPLICATION DOSE AND EXPOSURE TIME : Surfactants are tested at a concentration of 10% w/v or v/v in 0.9% saline. A 20% (200 mg/ml) solution or suspension of the solid test article in 0.9% saline (or other vehicle as specified by the Sponsor) will be prepared using a mortar and pestle if necessary. 10 minute exposure.
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: yes/no. If YES please specify duration
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After 10 (±1) minutes), the test article, ethanol, or MEM was removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution containing phenol red. A final rinse was made with MEM without phenol red. The anterior and posterior chambers of the holders were then refilled with fresh MEM solution. Opacity measurements were made following the 10-minute exposure and MEM solution refill.
- POST-EXPOSURE INCUBATION:
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490)
- Others (e.g, pertinent visual observations, histopathology): (please specify)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- -0.08
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: See Remarks
- Remarks:
- Corrected Mean Optical Density
- Run / experiment:
- Mean
- Value:
- -0.005
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 0
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein leakage
- Remarks:
- Corneal permeability
- Run / experiment:
- Mean
- Value:
- 0.016
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: None
DEMONSTRATION OF TECHNICAL PROFICIENCY: CRO is technically proficient in running the OECD 437.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values if different from the ones specified in the test guideline: Per OECD 437. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the test, DiBrORMA is not considered an eye irritant.
- Executive summary:
The corneal irritation and damage potential of DiBrORMA was tested in the Bovine Corneal Opacity and Permeability test (BCOP). The study was performed in compliance with EPA GLP 40 CFR 160 and 792, FDA GLP 21 CFR 58, and OECD GLP (1997). The test method was based on OECD 437 (2009). A pretest was performed to measure pre-exposure opacity of the test corneas against the control corneas blanks. The corneas were prepared in cell culture and incubated at 32˚C for at least 1 hour prior to exposure. For the exposure, corneas (3/test article) were treated with 0.75 mL of undiluted liquid expressed from the test article and then were incubated at 32˚C for 10 minutes. At the end of the exposure, the corneas were washed and incubated in fresh medium for an additional 2 hours. Opacity was evaluated using an opacitometer after the 2 hour post-exposure incubation. Following opacity readings, the cell culture medium was replaced with Na-fluorescein medium and incubated for approximately 90 minutes. Following the 90 minute exposure, permeability was measured. The mean in vitro irritation score (IVIS) was calculated and the scores were classified according to protocol defined categories. Ocular exposure to DiBrORMA in the test resulted in an IVIS = -0.08, the mean opacity was 0.0 and the mean permeability score was 0.016. Based on the results of the test, DiBrORMA is not considered an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Based on the results of the eye irritation study, DiBrORMA does not meet the classification criteria for eye irritation.
DiBrORMA is not corrosive to skin, but data on skin irritation potential are not available. Out of an abundance of caution, and because this chemical class can be irritating to skin, DiBrORMA is classified for skin irritation, GHS Category 2.
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.