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EC number: 805-561-2 | CAS number: 350601-49-9
- 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
![](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:
- 18 January 2013 to 27 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Appearance: Variable coloured powder
- Storage conditions of the test material: Ambient (18 to 36 °C)
- pH: The pH of the test material as a 10 % aqueous solution was 5.05
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 to 8 months
- Weight at study initiation: 2.75 to 2.86 kg
- Fasting period before study: No
- Housing: The rabbits were housed individually in rabbit cages (size: approximately 65 cm long x 65 cm deep x 45 cm high) with a noryl shallow cage body and facilities for pelleted feed and drinking water. The litter collection trays (noryl waste tray) were changed daily (except on Sundays). A noryl perforated raised shelf was provided to the animals for enrichment.
- Diet (e.g. ad libitum): Rabbit feed was provided ad libitum in a stainless steel feed hopper.
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in a water filter-cum-purifier was provided to animals ad libitum in 750 mL bottles with sipper tubes. The water in the bottles was replenished once daily and the water bottles were changed once a week.
- Acclimation period: Five to six days under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 °C
- Humidity (%): 65 to 66 % (relative)
- Air changes (per hr): 12 to 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours of light and 12 hours of dark
IN-LIFE DATES: From: 18 January 2013 To: 27 January 2013
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of each rabbit remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- The eye lids were gently held together for about one second, in order to minimise loss of the test material.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male animals
- Details on study design:
- TEST MATERIAL INSTALLATION
- Eye examinations: Prior to instillation, both eyes of each rabbit were examined with the aid of a pen light for irritation and ocular defects. The eyes were then checked for opacity using ophthalmic fluorescein sodium strips. The eyes were then irrigated with enough physiological saline (0.9 % NaCl) to remove any excess fluorescein (approximately 30 seconds). Using an ultraviolet lamp, the eyes were checked and evaluated for pre-existing corneal damage. No corneal defects were observed in any of the animals.
The finely ground test material was placed in the everted lower lid (conjunctival sac) of the left eye of each of three rabbits in a stepwise manner.
- Stepwise exposure of animals: A single rabbit was initially exposed to the test material. Prior to instillation, a local anaesthetic (4 % Lidocaine) was used in both the test and control eye. No corrosive effect or irritation was observed; hence the test was completed using two additional animals.
SCORING SYSTEM: The eyes were evaluated with the illumination of a white light source at intervals of approximately 1, 24, 48 and 72 hours post instillation of the test material according to the "Scale for Scoring Ocular Lesions" (Draize, 1944).
TOOL USED TO ASSESS SCORE: At 24 hours post installation, the eyes were checked for opacity using ophthalmic fluorescein sodium strips. The eyes were then irrigated with enough physiological saline (0.9 % NaCl) to remove any excess fluorescein (approximately 30 seconds). Using an ultraviolet lamp, the eyes were evaluated to verify the extent or absence of corneal damage.
OBSERVATIONS
- Clinical Observations: The rabbits were observed for clinical signs of toxicity and mortality 4 times (at hourly intervals) on the day of test material instillation and once daily thereafter until the end of the observation period.
- Body Weights: Body weights were recorded at the start of acclimatisation, day 1 of treatment (just before test material instillation) and at termination of observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The conjunctivae score for all animals at all time points was 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The chemosis score for all animals at all time points was 0
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The discharge score for all animals at all time points was 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The iris score for all animals at all time points was 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The cornea score for all animals at all time points was 0
- Irritant / corrosive response data:
- There was no eye irritation (iritis, conjunctival irritation or corneal opacity) observed in any treated eye during the study at 1, 24, 48 and 72 hours post instillation.
- Other effects:
- There were no clinical signs of toxicity observed, and none of the animals died, during the study.
The body weights of all rabbits increased slightly throughout the observation period. See Table 1.
Any other information on results incl. tables
Table 1: Body Weight
Rabbit Number |
Body weight (kg) |
||
At start of acclimatisation |
At treatment |
At termination of observation |
|
RB9718 |
2.65 |
2.75 |
2.82 |
RB9719 |
2.78 |
2.85 |
2.92 |
RB9720 |
2.80 |
2.86 |
2.94 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material caused no irritation to the eye of male New Zealand White rabbits and requires no classification in accordance with EU criteria.
- Executive summary:
The potential of the test material to cause eye irritation in male New Zealand White rabbits was assessed in accordance with the standardised guidelines OECD 405 and US EPA OPPTS 870.2400 under GLP conditions.
The test was performed in a stepwise manner. A single rabbit was initially exposed to the test material. Since the test material was not corrosive or severely irritating the study was completed using two additional rabbits.
0.1 g of the finely ground test material was placed in the everted lower lid (conjunctival sac) of the left eye of each of three rabbits. The lids were gently held together for about one second, in order to minimise loss of the test material. The right eye of each rabbit remained untreated and served as the reference control. The eyes were evaluated at 1, 24, 48 and 72 hours post instillation according to the Draize scale for scoring ocular lesions.
There was no eye irritation (iritis, conjunctival irritation or corneal opacity) observed in any treated eye during the study at 1, 24, 48 and 72 hours post instillation.
There were no clinical signs of toxicity observed and none of the animals died during the study. All rabbits appeared healthy and gained body weight throughout the observation period.
Under the conditions of this study, the test material caused no irritation to the eye of male New Zealand White rabbits and requires no classification in accordance with EU criteria.
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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