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EC number: 270-331-5 | CAS number: 68424-95-3
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4th June 1991 - 13th August 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- On day 1 on the screening portion of the study, the test animals receiving 0.3 g/kg bw of test material inadvertently did not receive a PM observation. This devaition has not compromised any aspect of the study as reported by the study author.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 225 - 399 g
- Fasting period before study: yes, fasted overnight prior to dosing
- Housing: groups of two in wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: four days before being used
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test material was administered undiluted and as a 20% w/v formulation in distilled water. Based on the results from this initial phase, a dilution of 5% w/v in distilled water was selected for administration.
- Doses:
- 0.5 g/kg bw
0.3 g/kg bw
0.2 g/kg bw
0.1 g/kg bw - No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: All animals were observed closely for gross signs of systemic toxicity and mortality several times during the day of dosing, and at least twice daily thereafter for a total of 14 days. Body weights was measured for each animal on the day of dosing, on day 7 of the observation period or following the death of any animals which does not survive this period.
- Necropsy of survivors performed: A gross necropsy was performed on any animal which dies. A gross necropsy was performed on each surviving animal at the end of the study.
- Other examinations performed: clinical signs, body weight,organ weights.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 238 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 0.198 - < 0.287
- Mortality:
- At the top dose of 0.5 g/kg bw mortality occurred in all 10 animals.
Seven out of 10 animals died at 0.3 g/kg bw dose.
Four out of 10 animals died following dosing of 0.2 g/kg bw.
No mortality was observed at the 0.1 g/kg bw dose. - Clinical signs:
- The most prevalent clinical changes for all dose groups noted during the observation period included urine and fecal stains, saliva discharge and stains, dried red stains on muzzle and around eyes, eye squinting, piloerection, ataxia, body tremors, laboured and shallow respiration, slight to severe depression, viscous red blood like discharge from mouth, bloated appearance to the abdomen, and spasms in the abdominal area.
- Body weight:
- No change to body weights were noted during the study.
- Gross pathology:
- Gross necropsy findings in one animal which survived the observation period included an enlarged spleen, the stomach wall appeared transparent, a lobe of the liver, the stomach, and the spleen appeared to be attached together by a membrane-like structure. With the exception of the above animal, all other animals which survived the observation period exhibited no gross pathological findings. In the animals that were found dead the following common findings were observed: Lungs, spleen and liver mottled, stomach wall white in colour and distended with gas, stomach contained substance/paste, intestines were yellow and greatly distended, kidneys appeared pale and congested.
Any other information on results incl. tables
Phase 1:
Dose (g/kg bw) | Concentration | Mortality (no. dead/no.dosed) |
4.0 | Undiluted | 10/10 |
1.0 | Undiluted | 9/10 |
0.4 | Undiluted | 10/10 |
0.16 | Undiluted | 7/10 |
0.0632 | 20% w/v in distilled water | 3/10 |
Phase 2:
Dose (g/kg bw) | Mortality (no. dead/no.dosed) |
0.5 | 10/10 |
0.3 | 7/10 |
0.2 | 4/10 |
0.1 | 0/10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The rat oral LD50 is 238 g/kg bw in male and female animals, with 95% confidence limites of 0.198 g/kg bw to 0.287 g/kg bw.
- Executive summary:
In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 500, 300, 200 or 100 mg/kg bw (single administration). Mortalities were observed at all dose groups except for in the 100 mg/kg bw group. The most prevalent clinical changes for all dose groups noted during the observation period included urine and fecal stains, saliva discharge and stains, dried red stains on muzzle and around eyes, eye squinting, piloerection, ataxia, body tremors, laboured and shallow respiration, slight to severe depression, viscous red blood like discharge from mouth, bloated appearance to the abdomen, and spasms in the abdominal area. The most common abnormalities found at macroscopic post-mortem examination included effects in the liver, kidneys, stomach, intestines and the spleen. There were no adverse effects noted for body weight gain.The oral LD50 is 238 mg/kg bw.
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