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EC number: 220-284-1 | CAS number: 2700-30-3
- 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
Skin:
The MatTek EpiDerm™ Skin Corrosivity Test is performed on the substance. The mean viability at 3 minutes and 60 minutes are 88.6% and 10%. The test substance is skin corrosive.
Eye:
The Bovine Corneal Opacity and Permeability Test is performed on the test substanc. The IVIS value is 58.08, the test substance is eye corrosive.
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:
- From 30 Mar 2021 to 22 Apr 2021
- Reliability:
- 1 (reliable without restriction)
- 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:
- Batch number: M-O303190723301F
Purity: 99.68% - Test system:
- human skin model
- Source species:
- human
- Justification for test system used:
- The EpiDerm™ Skin Model closely parallels human skin, and is recommended by test guidelines.
- Vehicle:
- other: Tissue Culture Water (TCH2O)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm™ Skin Model (EPI-200)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37±1°C
- Temperature of post-treatment incubation (if applicable):
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 100 μl of the test article were mixed with 1 ml of MTT solution (1 mg/ml thiazolyl blue tetrazolium bromide diluted in Dulbecco's Modified Eagle's Medium (DMEM)).
- Incubation time: The tissues were then returned to the incubator for an MTT incubation period
of 3 hours ± 10 minutes.
- Spectrophotometer: microplate reader (μQuant Plate Reader, BioTek® Instruments, Winooski, VT).
- Wavelength: 540 nm
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 50 μl of the test article were applied to the top of each EpiDerm™ tissue.
- Duration of treatment / exposure:
- The test article remained in contact with the EpiDerm™ tissue for 3 minutes at room temperature and 60 minutes at 37±1°C, 5±1% CO2.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes exposure
- Value:
- 88.6
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes exposure
- Value:
- 10
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean OD of the negative control tissues was 1.686 at 3 minutes and 1.611 at 60 minutes, which met the acceptance criterion (OD ≥ 0.8).
The mean relative tissue viability of the 60-minute positive control was 2.5%, which met the acceptance criterion (<15%).
Viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 2.5% to 4.1%. Viability differences between the two identically treated tissues at 60 minutes were 0.2% to 1.3%. Inter-tissue viability differences at both time points met the acceptance criterion (≤30%). - Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test substance is skin corrosive.
- Executive summary:
The MatTek EpiDerm™ Skin Corrosivity Test is performed on the substance. The mean viability at 3 minutes and 60 minutes are 88.6% and 10%. The test substance is skin corrosive.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
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:
- From 30 Mar 2021 to 01 Apr 2021
- Reliability:
- 1 (reliable without restriction)
- 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 (incl. QA statement)
- Specific details on test material used for the study:
- Batch number: M-O303190723301F
Purity: 99.68% - Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Bovine eyes (from cattle at least six months old) were obtained from a local abattoir by Spear Products (Coopersburg, PA) and transported to MB Research in Hanks’ Balanced Salt Solution (HBSS) with penicillin-streptomycin on ice, in an insulated cooler, on 01 Apr 2021.
- Selection and preparation of corneas: The eyes were examined after receipt from the abattoir. Any cornea with gross abnormalities (e.g., neovascularization, pigmentation, opacity or scratches) was discarded. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 ml
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: MEM
POSITIVE CONTROL USED: 100% Ethanol
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After 10 (± 1) minutes, the test and control
articles were removed from the epithelium of the corneas and anterior chamber of the holder by washing with MEM 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.
- POST-EXPOSURE INCUBATION: All corneas were incubated at 32 (± 1)°C for an additional two hours, MEM was then removed and replenished in each cornea holder.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of each cornea was measured by comparing the treated cornea to the blank supplied with the opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of Spectronic 20-D Colorimeter Spectrophotometer (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: the decision criteria as indicated in the TG was used. - Irritation parameter:
- in vitro irritation score
- Value:
- 58.08
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance is eye corrosive.
- Executive summary:
The Bovine Corneal Opacity and Permeability Test is performed on the test substanc. The IVIS value is 58.08, the test substance is eye corrosive.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation / corrosion:
EpiDerm™ Skin Corrosivity Test OECD 431: mean viability at 3 minutes and 60 minutes are 88.6% and 10%. The test substance is skin corrosive.
According to Regulation (EC) No 1272/2008, table 3.2.1, this substance should be classified as Category 1 for this endpoint.
Eye irritation:
Bovine Corneal Opacity and Permeability Test OECD 437: IVIS value is 58.08, the test substance is eye corrosive.
According to Regulation (EC) No 1272/2008, table 3.3.1, this substance should be classified as Category 1 for this endpoint.
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