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EC number: 944-548-7 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000.03.07 - 2000.07.04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The nominal temperature of the freezer was kept at < -10oC and not <-20 oC as, and the relative humidity in the animal holding room was up to 15% lower than stated in the protocol. The deviations are not considered to compromise the study integrity
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The nominal temperature of the freezer was kept at < -10oC and not <-20 oC as, and the relative humidity in the animal holding room was up to 15% lower than stated in the protocol. The deviations are not considered to compromise the study integrity
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- The nominal temperature of the freezer was kept at < -10oC and not <-20 oC as, and the relative humidity in the animal holding room was up to 15% lower than stated in the protocol. The deviations are not considered to compromise the study integrity
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: Cream powder (84% w/w)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL (MI3 dried)
- Source and lot/batch No.of test material: C202483
- Expiration date of the lot/batch: 2001.05.31
- Purity: 98.4%
- Purity test date: 2001.05.31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: < -10 degrees Celcius
- Stability under test conditions: NA
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in vehicle (water)
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: NA
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Purified water (Elgastat purifier used)
- Final preparation of a solid: 100mg/ml MI3 in water, pH of 8.0.
FORM AS APPLIED IN THE TEST (if different from that of starting material): solid dissolved in purified water.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Rabbit (New Zealand White rabbit)
- Sex: male and female
- Age at study initiation: 11 - 14 weeks.
- Weight at study initiation: 1.97 - 2.54 kg
- Housing: Single housed in floor-pens with wood chips bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 40 – 80 %
- Air changes (per hr): at least 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
IN-LIFE DATES: From: To: at least 14 - 16 days
Test system
- Vehicle:
- water
- Controls:
- other: The unexposed eye of the same animal served as a untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- single instillation dose into the left conjunctival
- Observation period (in vivo):
- Observations were recorded at: immediately after dosing, 30 min, one hour after dosing and at least twice within the first 24 hours after dosing. Thereafter observations were made once a day up to the third day after exposure.
However, the observation period was extended for the sentinel to five days to allow resulution of minor iridial changes prior to dosing of the remaining animals. - Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): NA
- Time after start of exposure: NA
SCORING SYSTEM: Standard grading scheme (SGS) graded 0 to 4 (where 0 is no response and 4 is the most severe response).
The following endpoints were evaluated/scored (Sting repsonse; Cornea - degree of opacity; Cornea -area of corneal opacity; Iris; Conjunctivae- redness; Conjunctivae - chemosis, and Conjunctivae -discharge)
TOOL USED TO ASSESS SCORE:fluorescein and ultraviolet light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.1
- Max. score:
- 0.3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- - Lesions and clinical observations: No indications of systemic toxicity or ill health were noted for any of the rabbits during the study. MI3 caused practically no initial sting reaction in two animals and a moderate sting in the third.
- Ophthalmoscopic findings: A darkned/red area appeared aorund the iris approximately four hours after instillation in the sentinel animal, but had disappeared by the 24 hour assessment. However, a residual dark speck in the iris appeared from Day 3 to Day 5, and disappeared at Day 6. It is not known if this is a direct result of the indtillation procedure, but it did not apear in the two other animals.
- Histopathological findings: NA
- Effects of rinsing or washing: NA
- Other observations: the eyes of all rabbits were overtly normal by the 48 hour examination with the exception of the persistant dark speck in the iris of the sentinel rabbit until Day 6.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Study was conducted to determine the irritation caused to the rabbit eye following a single instillation of MI3 into the conjunctival sac. The study was designed in accordance with OECD guideline method 405. One male and two female rabbits received a single instillation of 0.1 mL MI3 into the conjunctival sac of the eye. There was no indicative of systemic toxicity or ill health for any of the rabbits. The instillation caused slight changes in the conjunctivae that resolved within 24 or 48-hours. An exception was a persistent dark speck in the edge of the iris of the sentinel rabbit only. The cornea of each eye was overtly unaffected.
- Executive summary:
The Study was conducted to determine the irritation caused to the rabbit eye following a single instillation of MI3 into the conjunctival sac. The study was designed in accordance with OECD guideline method 405, the commission directive 92/69/EEC, Method B5, and the US EPA Health effects test Guidelines OPPTS 870.2400. One male and two female rabbits received a single instillation of 0.1 mL MI3 into the conjunctival sac of the eye. There was no indicative of systemic toxicity or ill health for any of the rabbits. The instillation caused practically no initial sting reaction in two animals and a moderate sting reaction in the third. Only minimal effects were observed after instillation of MI3 to eyes of all three animals. These effects were a slight reddening of the conjunctivae, a slight injection of the conjunctival vasculature, and production of a very slight discharge which all disappeared after 24 or 48-hours. An exception was a persistent dark speck in the edge of the iris of the sentinel rabbit only. The cornea of each eye was overtly unaffected.
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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