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Diss Factsheets
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EC number: 310-115-0 | CAS number: 102506-09-2
- 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:
- 3 November 2016 - 22 November 2016
- 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:
- 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)
Test material
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- other: in-vitro test
- Strain:
- other: isolated bovine cornea
- Details on test animals or tissues and environmental conditions:
- TEST MATERIAL
- Source: slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands)
- Acclimation period: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions. Then, the corneas were dissected and incubated in incubation medium at 32 +/- 1°C in an incubation chamber for 1 hour.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 +/- 1°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- An amount of 750 µl of either the negative control, positive control or test item was applied directly on the corneas in such a way that the cornea was completely covered.
- Duration of treatment / exposure:
- The corneas were incubated in a horizontal position for 10 +/- 1 minutes at 32 +/- 1°C.
- Duration of post- treatment incubation (in vitro):
- 120 +/- 10 minutes at 32+/-1°C.
- Details on study design:
- The aim of this study was to evaluate the ocular irritancy of the test item as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea.
PROTOCOL
- For each treatment group (negative control, positive control and test item), three replicates were used.
- The opacity of each cornea was determined before exposure.
- The corneas were exposed for 10 minutes.
- After the incubation the change in opacity for each individual cornea (including the negative control) was determined.
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated.
INTERPRETATION
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro irritancy score (IVIS)
- A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- -0.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- The negative control showed no irritation (mean IVIS was 0.443). The positive control induced a very severe irritation on the cornea, mean IVIS was 195.5. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. The mean in vitro irritancy score of the test item was -0.8 after 10 minutes of treatment with the test item.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- ALBRITE CIX(N) is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test.
- Executive summary:
A GLP compliant in-vitro study was performed according to OECD Guideline 437 in order to evaluate the ocular irritation properties of ALBRITE CIX(N) on an isolated bovine cornea. The possible ocular irritancy of the test item was tested through topical application for approximately 10 minutes. For each treatment group (negative control, positive control and test item), three replicates were used. After removal of the test item and two hours post-incubation, opacity and permeability values were measured. After treatment, the IVIS (in vitro irritancy score) in the controls is within the acceptability criterion. The positive control showed clear irritating effects. ALBRITE CIX(N) showed no effects on the cornea of the bovine eyes. The IVIS score is -0.8 and therefore it can be concluded that ALBRITE CIX(N) is not a severe eye irritant in the BCOP Test.
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.
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