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EC number: 611-631-1 | CAS number: 58190-57-1
- 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
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD 405. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-ethyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene
- EC Number:
- 611-631-1
- Cas Number:
- 58190-57-1
- Molecular formula:
- C11H23N3O3Si
- IUPAC Name:
- 5-ethyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene
- Reference substance name:
- 2-propanone, 2,2’,2’’-[O,O’,O’’-(ethylsilylidyne)trioxime]
- IUPAC Name:
- 2-propanone, 2,2’,2’’-[O,O’,O’’-(ethylsilylidyne)trioxime]
- Details on test material:
- - Name of test material (as cited in study report): EAC3
- Physical state: Liquid
- Analytical purity: 92.13 %
- Lot/batch No.: 1000061820
- Expiration date of the lot/batch: 11 January 2013
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%), Protected from humidity
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: ~13 weeks old (adult)
- Weight at study initiation: 3294 – 3525 g
- Housing: Individually in AAALAC approved metal wire rabbit cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 49 – 89 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 72 hours.
- Number of animals or in vitro replicates:
- 3 male animals.
- Details on study design:
- OBSERVATIONS: The eyes were examined at 1, 24, 48 and 72 hours after treatment. Any clinical signs of toxicity or signs of ill-health during the study were recorded. Individual body weight was recorded at the beginning of the experiment and before euthanasia
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #3
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- other: mean 24-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- animal #3
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- Initial Pain Reaction (IPR) (score 2) was observed in all animals. One hour after the application: Conjunctival redness (score 1 or 2), conjunctival chemosis (score 1 or 2) and conjunctival discharge (score 2 or 3) were found in all animals. At 24 hours after the application: Conjunctival redness (score 1) was found in all animals. In addition conjunctival discharge (score 1) was noted in one animal. At 48 and 72 hours after the application no signs of eye irritation or other clinical signs were observed. As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation.
Any other information on results incl. tables
No mortality was observed.
The body weight and body weight change were considered to be normal with no indication of a treatment related effect.
There were no clinical signs observed that could be related to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of 0.1 mL of EAC3 into one eye of each of three rabbits resulted in effects conjunctival redness (score 1) in all animals and conjunctival discharge (score 1) in one animal att 24 hours after the application. Based on these results, EAC3 was considered to be non irritant to the eye according to Regulation (EC) No 1272/2008.
- Executive summary:
An acute eye irritation study of the test item EAC3 was performed in New Zealand White rabbits according to OECD Guideline 405 and GLP. 0.1 mL of the test item was placed as a single dose into the conjunctival sac of one eye of each animal (3 male rabbits). The untreated right eye served as control. Individual body weight was recorded at the beginning of the experiment and before euthanasia. Morbidity and clinical signs of toxicity were checked daily. No adverse effects were observed. The eyes were examined at 1, 24, 48 and 72 hours after the application. Initial Pain Reaction (IPR) (score 2) was observed in all animals. At 24 hours after the application conjunctival redness (score 1) was found in all animals and conjunctival discharge (score 1) was noted in one animal. The effects were fully reversible within 48 hours. Based on these results, EAC3 was considered to be non irritant to the eye according to Regulation (EC) No 1272/2008.
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