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EC number: 824-772-0 | CAS number: 2060540-82-9
- 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:
- 20 February 2017 - 22 June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 437 (In vitro eye irritation)
- Version / remarks:
- 26 July 2013
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- - Source: bovine eyes were obtained from freshly slaughtered cattle at the abattoir EVA, Saint Pierre sur Dives, France.
- Age at study initiation: as French Authorities avoid the use of any organs from the head of bovines aged more than 12 months, bovine cattle were up to 12 months old (typically, 5 to 8 months old).
- Transport from Supplier to CiToxLAB France: the eyes were transported to CiToxLAB France at
ambient temperature, immerged in buffered Hanks medium containing an antibiotic [Hank’s Balanced Salts
Solution (HBSS) plus penicillin/streptomycin (100 units/100 µg/mL final)]. A container with smooth internal
surfaces was used for the transport to avoid damage to the corneas.
- Storage of the corneas: as the corneas were not used immediately, they were stored after washing. Each cornea was stored individually in 12 mL of M199 medium containing 5% dextran, plus penicillin/streptomycin, at +4°C, for a maximum of 24 hours before use.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- other: Reference item: pre-formulation of isopropanol at 1.5% (w/w) in water for injections diluted at the concentration of 10% (w/v) in water for injections.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL
- Concentration: 10% in vehicle
RE§FERENCE ITEM
- Amount applied: 750 µL
- Concentration: 10% in vehicle - Duration of treatment / exposure:
- Exposure period of 10 minutes (± 30 seconds), followed by rinsing
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- 2 hours (± 10 minutes)
- Number of animals or in vitro replicates:
- 3 corneas per item
- Details on study design:
- EYES SELECTION
The corneas were carefully examined macroscopically before their assembly in the holders, in order to detect the presence of any defects. Any corneas with defects were discarded. The corneas were then mounted in the corneal holders with the endothelial side against the O-ring of the posterior chamber. Each cornea was identified with the corresponding holder number. After pre-incuvbation, corneas that showed any macroscopic defect or an opacity value over 7 were discarded.
TREATMENT
Three corneas from the same series were always processed in the same order at each step. The medium of the anterior chamber was removed and each item was applied onto the epithelium of the cornea for 10 minutes in a water bath at +32°C (± 1°C).
REMOVAL OF TEST SUBSTANCE
The purpose of rinsing was to eliminate as much items as possible, while taking care not to damage the cornea. On completion of the treatment period, the test item formulation and the reference item were removed from the front opening of the anterior chamber (closed-chamber method) and the epithelium was rinsed as follows:
- the anterior chamber was emptied using a metal gavage tube attached to a vacuum pump,
- the corneas were rinsed four times for the test item formulation and three times for the reference item with pre-warmed cMEM containing phenol red (i.e. until the test item formulation had been completely removed from the chamber or until the phenol red was not discoloured). Then, the corneas were finally rinsed with pre-warmed cMEM without phenol red.
SCORING SYSTEM
- Opacity:
An opacitometer was used to measure light transmission (i.e. the level of opacity) through the center of each mounted cornea. The average change in opacity for the corneas treated with the vehicle control was calculated and this value was subtracted from the change in opacity for each cornea treated with test item formulation, reference item or positive control to obtain a corrected opacity value (cOPT). When the average change in opacity for the corneas treated with the negative/vehicle control was negative, it is considered equal to 0.
The mean cOPT value of each series of three corneas was calculated from the individual corrected opacity values.
- Permeability:
After the second opacity measurement, the medium of the anterior chamber was removed and the anterior chamber received 1 mL of a fluorescein solution in a water bath at +32°C (± 1°C) for 90 minutes (± 5 minutes). At the end of incubation, the maximum volume of cMEM recoverable from the posterior chamber of each holder was transferred into an identified tube. The corrected OD490 nm (cOD490 nm) value (i.e. permeability) for each cornea treated by test item formulation or positive control was calculated by subtracting the average negative (or vehicle) control cornea OD490 nm value from the original OD490 nm value of each cornea. When the average negative/vehicle control cornea OD490 nm value was negative, it is considered equal to 0.
- Scoring:
In vitro irritancy score (IVIS) = cOPT + (15 x cOD490 nm)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Remarks:
- test item
- Run / experiment:
- mean
- Value:
- 16
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Reference item
- Run / experiment:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Positive control
- Run / experiment:
- mean
- Value:
- 50
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS (macroscopic examination):
Vehicle corneas: non
Test item: fluorescein fixation and opacity on each cornea
Reference item: none
Posiive control: incease in thickness, fluorescein fixation and opacity on each cornea
ACCEPTANCE OF RESULTS:
For the validation of an experiment, the following criteria had to be fulfilled:
- the mean In Vitro Irritancy Score (IVIS) of the positive control corneas should fall within two Standard Deviations of the historical mean,
- the mean opacity and mean OD490 nm of the vehicle control corneas should be less than the established upper limit of historical mean.
Applicant's summary and conclusion
- Interpretation of results:
- other: No indication of severe irritation/corrosion
- Conclusions:
- Under the experimental conditions of this study, the ocular corrosive or severe irritant potential of the test item could not be predicted. The test item could not be identified as inducing serious eye damage (UN GHS Category 1) or as not requiring classification for eye irritation or serious eye damage (UN GHS No Category). According to OECD Guideline 437, further testing should be conducted for classification and labeling purposes.
- Executive summary:
The objective of this study was to evaluate the potential irritant and corrosive properties of the test item to the eye. The Bovine Corneal Opacity and Permeability (BCOP) test method can identify chemicals inducing serious eye damage and chemicals not requiring classification for eye irritation or serious eye damage.
The design of this study was based on the guideline OECD Guideline 437 and the study was performed in compliance with CiToxLAB France standard operating proceduresand with the OECD Principles of Good Laboratory Practice.
Method
Corneas obtained from freshly slaughtered calves were mounted in corneal holders. Both chambers of the corneal holder were filled with complemented MEM culture media (cMEM) and pre-incubated for 1 hour and 5 minutes (± 5 minutes) at +32°C.
Since the test item contained 1.5% isopropanol, a 1.5% (w/w) isopropanol solution was prepared in water for injections, and diluted identically to the test item before use, in order to investigate whether possible corneal damages would be related to the test item itself, or to its content in isopropanol.
A single experiment was performed using three corneas for each treated series (test item formulation, reference item, vehicle control and positive control).
Before the treatment, a first opacity measurement was performed on each cornea using an opacitometer.
The test item, tested at 10% (w/v) in the vehicle (0.9% NaCl), reference item, vehicle and positive controls were evaluated in a single experiment using a treatment time of 10 minutes and the closed-chamber treatment method. At completion of the treatment period, all items were removed from the front opening of the anterior chamber and the epithelia were rinsed.
The corneas were then incubated for 2 hours (± 10 minutes) at +32°C before a second opacity measurement was performed.
After the second opacity measurement, the medium of the anterior chamber was removed and filled with a fluorescein solution. The holders were then incubated vertically for 90 minutes (± 5 minutes) at +32°C.
At the end of the incubation period, the Optical Density of the solution from the posterior chamber of each holder was measured in order to determine the permeability of the cornea. Each cornea was then observed for opaque spots and other irregularities.
Results
Macroscopic examination
Opacity and fluorescein fixation were observed on the corneas treated with the test item formulation. No finding was noted on the corneas treated with the reference item.
In Vitro Irritancy Score
All acceptance criteria were fulfilled. The study was therefore considered as valid.
The mean In Vitro Irritancy Score (IVIS) of the test item formulation-treated corneas was: 16.
The mean In Vitro Irritancy Score (IVIS) of the reference item-treated corneas was: 0.
As the IVIS obtained with the reference item was 0, all findings noted on test item formulation-treated corneas were considered to be due to its 98.5% UVCB content, and not to the 1.5% isopropanol content.
As the mean IVIS was > 3 and < 55, the eye hazard potential of the test item could not be predicted. The test item could not be identified as inducing serious eye damage (UN GHS Category 1) or as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).
Conclusion
Under the experimental conditions of this study, the ocular corrosive or severe irritant potential of the test item could not be predicted. The test item could not be identified as inducing serious eye damage (UN GHS Category 1) or as not requiring classification for eye irritation or serious eye damage (UN GHS No Category). According to OECD Guideline 437, further testing should be conducted for classification and labeling purposes.
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.
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