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Diss Factsheets
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EC number: 484-460-1 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
In the OS1600 study, 5 of 7 rats died at 2000 mg/kg bw. Clinical signs were observed at >=175 mg/kg bw. There were no effects on body weights, macroscopic necropsy evaluations, or organ weights. Hematology evaluation of one rat at 550 mg/kg bw showed elevated RBCs, hematocrit and hemaglobin.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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: Guideline study conducted under GLP
- 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
- Species:
- other: Rat
- Strain:
- other: Wistar strain Crl:(outbred, SPF-Quality)
- 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 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in 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
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 234 mg/kg bw
- Mortality:
- Female: 2000 mg/kg bw; Number of animals: 7; Number of deaths: 5 Female: 550 mg/kg bw; Number of animals: 5; Number of deaths: 0 Female: 175 mg/kg bw; Number of animals: 1; Number of deaths: 0
- Clinical signs:
- 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, uncoordinated movements, flat posture, slow breathing, shallow respiration, piloerection, hypothermia 2000 mg/kg: Lethargy, hunched posture, uncoordinated movements, flat posture, slow breathing, shallow and laboured respiration, piloerection, watery discharge eye, ptosis, salivation The surviving animals had recovered from the symptoms between Days 2 and 5.
- Body weight:
- The mean body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated
animals of the same age and strain. - 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. - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Oral LD50 value of the test substance was estimated to be approximately 1234 mg/kg and was found to be within the range of 300-2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 234 mg/kg bw
- Quality of whole database:
- The study is a GLP compliant and has a Klimisch score 1.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The results from the OS1600 acute oral toxicity study were similar to the 2-PO acute oral toxicity study. 2-PO is the major hydrolysis product of OS1600.
Justification for classification or non-classification
OS1600 meets the GHS criteria for Acute Toxicity 4.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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