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EC number: 640-410-2 | CAS number: 2594-75-4
- 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:
- 2012-07-20 to 2012-09-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-propanone, 2,2’,2”-[O,O’,O”-(ethylsilylidyne)trioxime]
- EC Number:
- 611-631-1
- Cas Number:
- 58190-57-1
- IUPAC Name:
- 2-propanone, 2,2’,2”-[O,O’,O”-(ethylsilylidyne)trioxime]
Constituent 1
- Specific details on test material used for the study:
- - Product Name: EAC3
- CAS number: 58190-57-1
- Batch number: 1000061820
- Appearance: yellowish, liquid
- Manufacture date: 11 January 2010
- Expiry date: 11 January 2013
- Storage conditions: Controlled Room Temperature (15-25 °C, below 70 RH%), Protected from humidity
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: Rabbits were individually housed in AAALAC approved metal wire rabbit cages.
- Diet (e.g. ad libitum): Yes, UNI diet (Batch No.: 0070 05 12 / 0090 05 12 / 0100 06 12 , Expiry date: 02 August 2012 / 23 August 2012 / 25 September 2012) for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary
- Water (e.g. ad libitum): Yes, municipal tap water
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 49 – 89
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12
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:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 h after application
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- Application of the Test Item:
Three male animnals in acceptable health condition were selected for the test. First, an initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for a few seconds to prevent the loss of the test item. The contralateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first animal, two additional animals were treated.
Clinical Observations:
The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was suuficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity of signs of ill-health during the study were recorded. At the end of the observation period, each animal was sacrificied by intramuscular injectiona of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol 40% anaesthesia. Death was verified by checking pupil and corneal reflex and the absence of respiration.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
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:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The eyes were examined 1, 24, 48 and 72 hours after the application.
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.
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.
48 and 72 hours after the application: No signs of eye irritation or other clinical signs were noted.
As all signs of eye irritation had fully reversed, the study was terminated after a period of 72 hours observation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute eye irritation/corrosion study conducted according to OECD 405, the test item is considered to be non-irritant.
- Executive summary:
In a primary eye irritation study (OECD 405), 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of three male New Zealand White rabbits. The untreated eye served as control. Control and treated animals were observed at 1, 24, 48 and 72 hours after application. Irritation was scored by the method of Draize. Only very mild conjunctival reactions were noted, which were fully reversible within 48 hours. Based on the results, the test item can be considered as not irritating.
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