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EC number: 433-360-6 | CAS number: 34036-80-1
- 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
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to EPA OTS 798, similar to OECD 401. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 433-360-6
- EC Name:
- -
- Cas Number:
- 34036-80-1
- Molecular formula:
- C18H29N3O3Si
- IUPAC Name:
- 6-{[(butan-2-ylidene)amino]oxy}-3,9-dimethyl-6-phenyl-5,7-dioxa-4,8-diaza-6-silaundeca-3,8-diene
- Reference substance name:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime
- IUPAC Name:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): OS-9000
- Physical state: Light yellow liquid
- Expire date: May 14, 1998
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Laboratories, Inc., Portage, Michigan.
- Age at study initiation: young adult
- Weight at study initiation: 200-300g
- Fasting period before study: overnight
- Housing: The animals were housed individually in suspended stainless steel cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21.5-23.5 ºC (71-74ºF)
- Humidity: 39-53 %
- Air changes (per hr): 10-15 air changes/hour
- Photoperiod: 12-hour light/l2-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.98 mL/kg
DOSAGE PREPARATION (if unusual): Individual doses were calculated based on the animal's fasted (day 0) body weight.
RATIONALE FOR DOSE SELECTION: A range findint study was performed exposing one rat per sex per dose to 100, 500, 1000, 2000 and 3000 mg/Kg. Clinical observation, body weights and gross necropsy were analysed. The range-finding data indicated that the test article produced mortality at the highest tested dose level of 3000 mglkg level in females, but did not produce mortality at that level in the males. - Doses:
- 100, 500, 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: two times on study day 0 (postdose) and daily thereafter (days 1-14).
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, gross necropsy, organ weights, histopathohlogy
Organ weights: Heart, Kidneys (paired), Liver, Spleen, Testes (paired), Brain.
Retained tissues: Heart, Kidneys (paired), Liver, Spleen, Testes (paired), Brain, Femur (bone marrow), Ovaries, Thymus. - Statistics:
- Since the LD50 values could not be reliably calculated based on the mortality response, the LD50 was estimated based on the observed data.
Body weights, body weight gains and organ weights were analyzed by one-way analysis of variance.
Results and discussion
- Preliminary study:
- A. Range-Finding Study
1. Dosing
On day -1, the animals chosen for the range-finding study were weighed and fasted overnight. On day 0, the test article was administered orally as a single dose using a ball tipped stainless steel gavage needle attached to a syringe at the following levels: 100, 500, 1000, 20000, 3000 mg/kg.
Number of animals per sex per dose: 1 male, 1 female per dose.
2. Clinical Observations
The range-finding animals were observed for mortality on day 0 (post-dose) and on days 1-7. A general healthlmortality check was performed twice daily (in the morning and in the afternoon).
3. Body Weights
Individual body weights were obtained for the range-finding animals prior to fasting (day -1) and prior to dosing on day 0.
4. Gross Necropsy
All range-finding animals which died spontaneously during the study or were euthanized by carbon dioxide inhalation at study termination (day 7) were removed from study. No necropsy was performed.
The range-finding data indicated that the test article produced mortality at the highest tested dose level of 3000 mglkg level in females, but did not produce mortality at that level in the males.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The only mortality occurred on study day 1 at 2000 mgl/kg bw.
- Clinical signs:
- other: The most notable clinical abnormalities observed during the study included prostration, decreased activity, wobbly gait, rigidity upon handling, breathing abnormalities, urine stain, decreased defecation, partially closed eyelids and dark material around
- Gross pathology:
- Gross internal findings observed in the animal that died included abnormal content in the trachea, digestive tract and urinary bladder, reddened mucosa in the small intestine, mottled lungs, stained mucosa in the stomach, and dark red foci on the thymus. Significant gross internal findings observed at necropsy on study day 14 included blackish-purple spleens in the animals dosed at 500 and 2000 mglkg. Significant gross internal findings observed at necropsy on study day 14 included blackish-purple spleens in the animals dosed at 500 and 2000 mg/kg. Statistically significant increases in spleen weight relative to final body weight were observed for males dosed at 500 and 2000 mg/kg.
- Other findings:
- Organ weights: Statistical differences in absolute spleen weight were observed in the males dosed at 500 mg/kg. Although not statistically different, there was also an increase for the animals dosed at 2000 mg/kg. Statistically significant increases in spleen weight relative to final body weight were observed for males dosed at 500 and 2000 mg/kg. Increases in spleen weight relative to final body weight, while greater in females dosed at 500 and 2000 mg/kg, were not statistically significant. No other statistically significant differences were observed.
Any other information on results incl. tables
Under the conditions of this test, the acute oral LD50 in the rat was determined to be greater than 2000 mgl/kg. However, toxicity was observed in rats dosed at 2000 mgkg and 500 mgl/kg as expressed by adverse clinical signs and significant body weight decreases. The 100 mgl/kg dose group was considered to be NOAEL.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of test item was determined to be greater than 2000 mg/kg.
- Executive summary:
This study was performed to assess the short-term toxicity of test item in Sprague-Dawley rats when administered by gavage as a single oral dose according to EPA OTS EPA OTS 798.1175. This study is intended to provide information on the potential health hazards of the test article with respect to oral exposure. Under the conditions of this test, the acute oral LD50 in the rat was determined to be greater than 2000 mglkg. However, toxicity was observed in rats dosed at 2000 mg/kg and 500 mg/kg as expressed by adverse clinical signs and significant body weight decreases. The 100 mg/kg dose group was considered to be NOAEL.
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