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EC number: 484-460-1 | CAS number: 37859-55-5
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 484-460-1
- EC Name:
- -
- Cas Number:
- 37859-55-5
- Molecular formula:
- C16H33N3O3Si
- IUPAC Name:
- (4E,9E)-4,7,10-trimethyl-7-{[(E)-(pentan-2-ylidene)amino]oxy}-6,8-dioxa-5,9-diaza-7-silatrideca-4,9-diene
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approximately 9-12 weeks old
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean
- Fasting period before study: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the
test substance.
- Housing: Individually housed in labeled Macrolon cages (Mill type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo , S.P.P.S., Argenteuil, France) and paper as cage-enrichment 9Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF(R) Spezialdiatem GmbH, Soest, Germany)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: The acclimatization period was at least 5 days before the start of treatment under laboratory conditions. Accommodation was as described above except that the animals were group housed in labeled Macrolon cages (MIV type; height 18 cm)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3.0°C ( actual range: 19.5-21.6°C)
- Humidity (%): 30-70% (actual range: 31-81%)
- Air changes (per hr): 15 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE:
The test substance was dosed undiluted as delivered by the sponsor.
MAXIMUM DOSE VOLUME APPLIED:
2000 mg/kg (2.07 ml/kg) body weight - Doses:
- Frequency: Single dosage on Day 1
2000 mg/kg (2.07 mL/kg) body weight
550 mg/kg (0.569 mL/kg) body weight
175 mg/kg (0.181 mL/kg) body wieght
Dose volume calculated as dose level (g/kg)/ density (g/mL) - No. of animals per sex per dose:
- Test substance was administered by oral gavage to a female Wistar rat at 2000 mg/kg body weight. In a stepwise procedure twelve additional females were dosed at 175, 550 or 2000 mg/kg body weight. The animals were dosed sequentially one at a time.
- Control animals:
- no
- Details on study design:
- - Frequency of observations and weighing: Observations: Twice daily. Weighing: Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed:
- Clinical Signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded: Maximum grade 3: grading slight (1) to severe (3). Maximum grade 1: presence is scored (1)
- Necropsy: The animals surviving to the end of the observation period were sacrificed by oxygen/carbondioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.
- Organ Weights: The weight from the liver, kidneys and spleen were recorded from all animals that were necropsied after 21st of April 2008. These organs were also fixed in 10% buffered formalin (neutral phosphate buffered 4% formaldehyde solution) for posible further pathological investigations.
- Blood Sampling: As requested by sponsor, a blood sample was collected from aminal 13 (550 mg/kg) under iso-flurane 24 hrs post treatment. The sample was drawn from the retro-orbital sinus and collected into a tube prepared with EDTA for haematological parameters (0.5 mL) - Statistics:
- The LD50 was estimated based on maximum likelihood by means of the AOT425StatPGM
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 234 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg bw; Number of animals: 7; Number of deaths: 5
550 mg/kg bw; Number of animals: 5; Number of deaths: 0
175 mg/kg bw; Number of animals: 1; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: The decedents and moribund animal were found on the day of treatment (Day 1). Clinical signs observed during the study period were as follows: 175 mg/kg: Hunched posture. 550 mg/kg: Lethargy, hunched posture,
- Gross pathology:
- Effects on organs: The weights of the liver and kidneys animal 13 (550 mg/kg) and the liver, kidneys and spleen of animals 14 (2000 mg/kg) were within the normal range. The weight of the spleen of animal 13 (550 mg/kg) was 0.306 and just below the normal range (0.40 - 0.69 grams). No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- Haematology was perfomred on animal 13 (550 mg/Kg) and showed a slight increase in red blood cells, haemoglobin and haematocrit.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The Oral LD50 value of the test substance was estimated to be approximately 1234 mg/kg bw, within the range of 300-2000 mg/kg bw.
- Executive summary:
An acute oral toxicity study was performed with OS1600 in the rat in accordance with OECD Guideline 425 using the Up and Down procedure. Test item was initially administered by oral gavage to a female rat at 2000 mg/kg bw. In a stepwise procedure 12 additional females were dosed at 175, 550 and 2000 mg/kg bw. The animals were dosed sequentially one at a time. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). Animals at 2000 mg/kg bw were found dead. Clinical signes were observed at all doses, from hunched posture at 175 mg/ kg bw to lethargy, uncoordinated movements, slow breathing, shallow and laboured respiration, piloerection, discharge eye, ptosis and salivation at 2000 mg/kg bw. The surviving animals had recovered from this symptons. No effects were observed on the body weight gain. The liver and kidney weights of the two animals observed were within the historical data. Instead, the spleen weight was within the historical data in one of them and in the other one was lower. Slight increase in red blood cells, haemoglobi and haematocrit was observed in the analysed animal. No macroscopic abnormalities were observed. Based on these results, the LD50 of OS1600 in rats was determined to be ca. 1234 mg/kg bw and within the range of 300 -2000 mg/kg bw.
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