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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-31 to 2012-12-18
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- 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:
- - Name: EAC3
- Chemical name: 2-propanone, 2,2’,2”-[O,O’,O”-(ethylsilylidyne)trioxime]
- CAS No.: 58190-57-1
- Batch/Lot Number: 1000061820
- Molecular weight: 273.404
- Manufacture date: 11 January 2010
- Expiry date: 11 January 2013
- Purity: 92.13%
- Description: Yellowish liquid
- Storage conditions: Room temperature (15-25 °C, below 70 RH%), protected from humidity
- Safety precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was freshly formulated at a concentration of 250 mg/mL in the vehicle on the day of administration. The formulation container was stirred continiously up to finsihing the treatment.
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Young healthy adult rats, 10-11 weeks old
- Weight at study initiation: 230 – 240 g
- Fasting period before study: night before the treatment
- Housing: 3 animals / cage
- Diet (e.g. ad libitum): Yes, ssniff SM R/M "Autoclavable complete diet for rats and mice - breeding and maintenance"
- Water (e.g. ad libitum): Yes, tap water
- Acclimation period: at least 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 – 22.5
- Humidity (%): 37 – 69
- Air changes (per hr): 15 – 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- VEHICLE
- Lot/batch no. (if required): BCBH2687V
- Expiry date: 31 December 2013
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A limit of 2500 mg/kg bw dose was required by the Sponsor. The limit dose for this study was >2000 mg/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2500 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris. - Doses:
- 2500 mg/kg bw
- No. of animals per sex per dose:
- 3 females per step / two steps in total
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Frequency of weighing: The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly after.
- Necropsy: Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia. After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded. - Statistics:
- n.a.
Results and discussion
- Preliminary study:
- n.a.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- EAC3 did not cause mortality at a dose level of 2500 mg/kg bw.
- Clinical signs:
- other: Treatment with EAC3 at the dose level of 2500 mg/kg bw caused decreased activity (6/6), hunched back (6/6), prone position (4/6), incoordination (6/6), piloerection (5/6) and creeping gait (3/6). All animals were symptom free from three days after the tre
- Gross pathology:
- No macroscopic observations were present at a dose level of 2500 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats conducted according to OECD 423 no mortality occurred at the high dose of 2500 mg/kg bw. Hence, the LD50 value was determined to be greater than 2500 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (acute toxic class method, OECD 423), two groups of fasted, 10-11 weeks old, female Wistar rats (3 rats/group) were given a single oral dose of the test item (92.13% purity) in PEG 400 at the dose of 2500 mg/kg bw and were observed for 14 days. All animals survived until the end of the study showing only mild signs of toxicity. The most relevant clinical findings were decreased activity (6/6), hunched back (6/6), prone position (4/6), incoordination (6/6), piloerection (5/6) and creeping gait (3/6). All animals were symptom free from three days after the treatment.
Throughout the 14-day observation period, the body weight showed no indication of a test item-related effect. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step. Based on the results from this study, the oral LD50 in rats is considered to exceed 2500 mg/kg bw.
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