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EC number: 455-860-3 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experiment start date - 01 February 2005; Experiment end date - 01 March 2005; Study completion date - 23 March 2005.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC Ltd., Toxicology, Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland
Test material
- Reference substance name:
- FAT40819/A TE
- IUPAC Name:
- FAT40819/A TE
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FAT 40819/A
- Purity: Approx. 77%
- Lot/batch No.: Red ROE 420 BOP 01/04
- Expiration date: 2 November 2009
- Stability: Stable under storage conditions.
- Storage conditions: At room temperature (range of 20 ± 5 °C), light and moisture (dessiccator) protected.
Constituent 1
- Specific details on test material used for the study:
- Identity: FAT 40819/A
Description: Red brown powder
Batch number: Red ROE 420 BOP 01/04
Purity: approx. 77 %
Stability of test item: Stable under storage condition
Expiry date: 02 November 2009
Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature
Storage conditions: At room temperature.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, BP 0109, F-69592 L'Arbresle
- Age at treatment: 13 weeks
- Bodyweight at treatment: 2280-2435 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 38/04, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 68/04 and 93/04) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 21 days
- Observation period (in vivo):
- up to 21 days
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- TREATMENT:
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.1 g of FAT 40819/A was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
OBSERVATIONS:
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 2004/73/EC, April 29, 2004 at approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17, and 21 days after instillation. When present, corrosion and/or staining of conjunctivae, sclerae and cornea by the test item were recorded and reported.
CORNEA
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity.................................................................................................................................... 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible.............. 1
Easily discernible translucent area, details of iris slightly obscured....................................................................... 2
Nacreous area, no details of iris visible, size of pupil barely discernible.................................................................. 3
Opaque cornea, iris not discernible through the opacity........................................................................................ 4
IRIS
Normal,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)............................................................................................. 1
No reaction to light, hemorrhage, gross destruction (any or all of these).................................................................... 2
CONJUNCTIVAE
Redness (refers to most severe reading of palpebral and bulbar conjunctivae when compared with control eye) Blood vessels normal.. 0
Some blood vessels definitely hyperemic (injected)...................................................................................................................... 1
Diffuse, crimson color, individual vessels not easily discernible...................................................................................................... 2
Diffuse beefy red........................................................................................................................................................................ 3
Chemosis: lids and/or nictitating membranes
No swelling.................................................................................................................................................. 0
Any swelling above normal (including nictitating membranes)............................................................................ 1
Obvious swelling with partial eversion of lids.................................................................................................... 2
Swelling with lids about half-closed................................................................................................................. 3
Swelling with lids more than half-closed.......................................................................................................... 4
Discharge:
No discharge................................................................................................................................................. 0
Any amount different to normal (does not include small amount observed in inner canthus of normal animal).......... 1
Discharge with moistening of the lids and hairs just adjacent to the lids.............................................................. 2
Discharge with moistening of the lids and hairs, and a considerable area around the eye (running)......................... 3
Note: Reddening of the sclerae will be assessed using the same scoring grades as conjunctivae.
TOOL USED TO ASSESS SCORE:
Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- other: Only two animals could be evaluated due to swelling of the conjunctivae in the other animal.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00 for reddening and 0.00 for chemosis for all animals, respectively. No abnormal findings were observed in the iris of any animal at any of the measurement intervals. Very slight corneal opacity affecting the whole area which was attributed to staining produced by the test item was observed in one animal one hour after treatment. In one animal, reddening of the conjunctivae was not assessable one hour after treatment and at the observation performed 17 days after treatment due to marked swelling and due to staining produced by the test item, respectively. Slight reddening of the conjunctivae was noted in the remaining two animals at the 1-hour observation and in all animals from the 24-hour to the 72-hour examination. Additionally, slight reddening was noted in one animal at the readings 7, 10 and 17 days after treatment and in one further animal 10 days after treatment. Slight swelling to marked swelling with half-closed lids (chemosis) of the conjunctivae was observed one hour after treatment in all animals. Reddening of the sclerae was not assessable due to staining produced by the test item in all animals one hour after treatment, in two of these animals from the 24-hour reading to the 10-day examination and at the 17-day examination as well as in one animal at the observations performed 14 and 21 days after treatment. When assessable, no reddening of the sclerae was present. Slight to moderate ocular discharge with moistening of the lids and hair just adjacent to the lids was noted one hour after treatment in all animals. With the exception of staining produced by the test item no abnormal findings were observed in the treated eye of any animal 21 days after treatment, the end of the observation period for all animals.
- No corrosion of the cornea was observed at any of the reading times. - Other effects:
- - Marked red staining of the treated eyes produced by the test item was observed in all animals one hour after treatment and persisted up to test day 10 or 21 in two animals. Slight red staining persisted up to the 72-hour reading in the third animal and was observed from the 14- to 21-day examination in one animal. Red remnants of the test item were observed in the eye or conjunctival sac of one animal 1 hour after treatment.
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. One animal screamed after the application.
- The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance causes irreversible effects on the eye.
- Executive summary:
In a GLP-compliant eye irritation study, performed according to OECD guideline 405, test substance (0.1 g) was placed in the conjunctional sac of the left eye of 3 New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17, and 21 days after test item instillation. The instillation of the test substance into the eye resulted in mild to moderate and early-onset ocular changes, such as corneal opacity, reddening of the conjunctivae, discharge and chemosis. Slight to marked staining of the treated eyes produced by the test item was observed in all animals from the 1- to 72-hour examination and persisted up to the observation 21 days after treatment in two animals. The mean 24/48/72 h for corneal opacity, iris, conjunctivae, chemosis scores were 0, 0, 1, 0, respectively. With the exception of the staining, these effects were reversible and were no longer evident 21 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the iris of any animal at any of the examinations, no corrosion was observed at any of the measuring intervals and no clinical signs were observed.
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