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EC number: 203-600-2 | CAS number: 108-62-3
- 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
Endpoint summary
Administrative data
Description of key information
A study was performed to determine the acute oral median lethal dose (LD50 ) of the test material, administered as a suspension in arachis oil in the Sprague-Dawley CFY strain rat. The method used followed
that described in the OECO No. 401. Following a range-finding study, four groups, each of ten fasted animals (five males and five females), were given a single oral dose of test material preparation at dose levels of 100 to 800 mg/kg body weight. Two males treated with 800 mg/kg and one male treated with 400 mg/kg were found dead immediately after dosing. All other deaths were noted six or twelve hours after dosing. Principal signs of toxicity noted in both decedents and surviving animals were hunched posture, pilo-erection, lethargy and decreased respiratory rate. Occasional or isolated signs of increased salivation, ptosis, body tremors or occasional body tremors, red/brown staining around the eyes, snout and mouth with diuresis, diarrhoea, tonic convulsions, ataxia and coma. Signs of toxicity were first noted immediately after dosing. Surviving animals were normal two to eight days after dosing. All surviving animals showed expected gains in bodyweight over the study period. Common abnormalities noted in decedents were abnormally red or haemorrhaged lungs, dark or patchy pallor of the liver, with congestion of the small intestines. Sloughing of the gastric mucosa was also noted. In conclusion, the acute oral LD 50 was found to be 283 mg/kg (males/females).
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:
- April - June 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Description: Crystalline white powder
- Name: P0071
- Storage requirements: 4°C in the refrigerator - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 126 - 148g; females 114 - 148g
- Fasting period before study: yes
- Housing: housed in groups of up to five by sex in solid-floor PP-cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 45-55%
- Air changes (per hr): 15 changes/h
- Photoperiod (hrs dark / hrs light): 12h light / 12h darkness - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500, 200, 100, 50, 25, 10 mg/ml in pretest; 10, 20, 40, 80 mg/ml in main test
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: non-reactivity and suspensability - Doses:
- - Pretest: 5000, 2000, 1000, 500, 250, 100 mg/kg
- Main test: 100, 200, 400, 800 mg/kg - No. of animals per sex per dose:
- - Pretest: 1 male / 1 female per dose group
- Main test: 5 males / 5 females per dose group - Control animals:
- no
- Details on study design:
- Duration of observation period following administration:
Immediately after dosing and at 6, 12 and 18 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation
Frequency of observations and weighing:
Individual bodyweights were recorded on the day of treatment (day 0), days 7 and 14, and at death
Necropsy of survivors performed: yes
All animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained - Statistics:
- as prescribed in method
- Preliminary study:
- - 5000, 2000, 1000, 500 mg/kg: mortaliity: 2/2 (100%)
- 250, 100 mg/kg: mortaliity: 0/0 (0%) - Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 283 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 191 - 419
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 283 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 175 - 457
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 283 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 210 - 382
- Mortality:
- Two males treated with 800 mg/kg and one male treated with 400 mg/kg were found dead immediately after dosing. All other deaths were noted six or twelve hours after dosing.
- Clinical signs:
- other: 100 mg/kg All animals treated with 100 mg/kg showed hunched posture and piloerection immediately after dosing, six, twelve and eighteen hours after dosing and on day one. Additional signs of lethargy and decreased respiratory rate were also noted immediat
- Gross pathology:
- Common abnormalities noted in decedents were abnormally red or haemorrhaged lungs, dark or patchy pallor or the liver and congestion of the small intestines. Sloughing of the glandular region of the stomach was also noted. No abnormalities were noted at necropsy of surviving animals killed at the end of the study period.
- Other findings:
- None
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral LD 50 was found to be 283 mg/kg (males/females)
- Executive summary:
A study was performed to determine the acute oral median lethal dose (LD50 ) of the test material, administered as a suspension in arachis oil in the Sprague-Dawley CFY strain rat. The method used followed
that described in the OECO No. 401. Following a range-finding study, four groups, each of ten fasted animals (five males and five females), were given a single oral dose of test material preparation at dose levels of 100 to 800 mg/kg body weight. Two males treated with 800 mg/kg and one male treated with 400 mg/kg were found dead immediately after dosing. All other deaths were noted six or twelve hours after dosing. Principal signs of toxicity noted in both decedents and surviving animals were hunched posture, pilo-erection, lethargy and decreased respiratory rate. Occasional or isolated signs of increased salivation, ptosis, body tremors or occasional body tremors, red/brown staining around the eyes, snout and mouth with diuresis, diarrhoea, tonic convulsions, ataxia and coma. Signs of toxicity were first noted immediately after dosing. Surviving animals were normal two to eight days after dosing. All surviving animals showed expected gains in bodyweight over the study period. Common abnormalities noted in decedents were abnormally red or haemorrhaged lungs, dark or patchy pallor of the liver, with congestion of the small intestines. Sloughing of the gastric mucosa was also noted. In conclusion, the acute oral LD 50 was found to be 283 mg/kg (males/females).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 283 mg/kg bw
- Quality of whole database:
- Guideline study; Klimisch 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
Justification for classification or non-classification
Based on the results of this study, the test item has to be classified as "Acute toxic, Cat. 3, oral".
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