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EC number: 807-560-2 | CAS number: 123944-63-8
- 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
ACUTE ORAL
LD50 >5000 mg/kg bw; male/female rat; CFR Volume 16, Part 1500.30
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
- Study period:
- 25 June 1987 to 9 July 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Volume 16, Part 1500.30
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 215.5 - 224.0 g (males); 219.5 - 245.7 g (females)
- Fasting period before study: Yes. Food was withheld for an overnight period just before test material administration.
- Housing: Animals were maintained in individual cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
Animals were housed in temperature-controlled and humidity-monitored quarters.
IN-LIFE DATES: From: 17 June 1987 To: 9 July 1987 - Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after test material administration and once daily thereafter for 14 days. Mortality/moribundity were recorded twice daily. All animals were weighed just before test material administration, at Day 7, and at termination, or time of death.
- Necropsy of survivors performed: Yes. At termination, all the surviving animals were sacrificed and necropsied. Necropsies were also performed at time of death. Observations were recorded. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two female rats receiving the 5000 mg/kg dose had died by Day 2. All the remaining animals survived throughout the study.
- Clinical signs:
- other: A variety of clinical observations were noted in all the animals. These included soft faeces in two male and four female animals following test material administration and one female was urine stained; depression/slight depression was noted in one female
- Gross pathology:
- Observable gross pathology findings noted in four females involved the lungs, liver and spleen (discoloration) and the stomach and intestines (distended and abnormal contents). No gross pathology findings were observed in any of the males at time of necropsy.
- Other findings:
- The test material coloured the faeces and urine of the animals until Day 7.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the LD50 was estimated to be >5000 mg/kg bw in male and female rats.
- Executive summary:
The acute oral toxicity potential of the test material was investigated in accordance with the standardised guideline from the Code of Federal Regulations, Volume 16, Part 1500.30.
The test material was administered in distilled water via gavage to 5 male and 5 female albino Sprague-Dawley rats at a limit dose of 5000 mg/kg bw.
Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after test material administration and once daily thereafter for 14 days. Mortality/moribundity were recorded twice daily. All animals were weighed just before test material administration, at Day 7, and at termination, or time of death. At termination, all the surviving animals were sacrificed and necropsied. Necropsies were also performed at time of death. Observations were recorded.
Two female rats receiving the 5000 mg/kg dose had died by Day 2. All the remaining animals survived throughout the study. Prior to death, the two females that did not survive lost weight, while the surviving animals gained weight. A variety of clinical observations were noted in all the animals. All the surviving animals returned to normal by Day 8 and remained normal to Day 14.
Observable gross pathology findings noted in four females involved the lungs, liver and spleen (discoloration) and the stomach and intestines (distended and abnormal contents). No gross pathology findings were observed in any of the males at time of necropsy.
Under the conditions of this study the LD50 was estimated to be >5000 mg/kg bw in male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The study was conducted on a read-across material in accordance with a standardised guideline and was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997). It is considered that this, along with the high LD50, ensures that the study addresses this endpoint in a valid fashion. The quality of the database is therefore considered to be good.
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 acute oral toxicity potential of the test material was investigated in accordance with the standardised guideline from the Code of Federal Regulations, Volume 16, Part 1500.30.
The test material was administered in distilled water via gavage to 5 male and 5 female albino Sprague-Dawley rats at a limit dose of 5000 mg/kg bw.
Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after test material administration and once daily thereafter for 14 days. Mortality/moribundity were recorded twice daily. All animals were weighed just before test material administration, at Day 7, and at termination, or time of death. At termination, all the surviving animals were sacrificed and necropsied. Necropsies were also performed at time of death. Observations were recorded.
Two female rats receiving the 5000 mg/kg dose had died by Day 2. All the remaining animals survived throughout the study. Prior to death, the two females that did not survive lost weight, while the surviving animals gained weight. A variety of clinical observations were noted in all the animals. All the surviving animals returned to normal by Day 8 and remained normal to Day 14.
Observable gross pathology findings noted in four females involved the lungs, liver and spleen (discoloration) and the stomach and intestines (distended and abnormal contents). No gross pathology findings were observed in any of the males at time of necropsy.
Under the conditions of this study the LD50 was estimated to be >5000 mg/kg bw in male and female rats.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to acute oral toxicity.
In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to acute oral toxicity.
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