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EC number: 628-079-2 | CAS number: 3680-69-1
- 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
The acute oral toxicity is performed using up and down procedure according to OECD Guideline 425 under GLP.
The estimated oral LD50 and 95% confidence limits of the test item is 1161 (550 to 2000) mg/kg of body weight in female rats.
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:
- From 20 Dec 2016 to 01 Feb 2017
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Charles River, Raleigh NC, Stone Ridge NY and St. Constant Quebec
Canada
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable)
- Age at study initiation: 8 weeks
- Weight at study initiation: The pre-test body weight range was 193 - 279 grams.
- Fasting period before study: yes, 16-20 hours prior to dosing.
- Housing: The animals were individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Historical data:
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet No.5012) was available ad libitum except for 16-20 hours prior to dosing.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 550, 2000, 4000 mg/kg
- No. of animals per sex per dose:
- 2000 mg/kg (two females) and 4000 mg/kg (one female)
550 mg/kg: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects.
- Necropsy of survivors performed: All animals were humanely euthanized using CO2 following study termination and examined for gross pathology.
- Clinical signs including body weight: Observations included, but were not limited to, evaluation
of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behavior (e.g., self-mutilation, walking backwards). All animals were observed twice daily for mortality on Day 1 to Day 14. Body weights were recorded pre-test, weekly, and at death or termination in the survivors. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 161 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 550 - < 2 000
- Mortality:
- Three female rats died, by Day 1, following a single 2000 mg/kg (two animals) and 4000 mg/kg (one animal) oral dose.
Three female rats survived following a single 550 mg/kg oral dose. - Clinical signs:
- other: Dose Level: 2000 and 4000 mg/kg Prior to death, abnormal physical signs including piloerection, wetness of the nose/mouth area, lacrimation, chromorhinorrhea, lethargy, tremors, flaccid muscle tone, negative righting reflex, prostration, closed eyes, chro
- Gross pathology:
- Dose Level: 2000 and 4000 mg/kg
The gross necropsy revealed red staining of the nose/mouth area, wetness and brown and gray staining of the anogenital area, darker than normal lungs, excess fluid in the pleural cavity, abnormalities of the gastrointestinal tract, distention of the stomach (white fluid), pale areas on the liver and red fluid in the bladder.
Dose Level: 550 mg/kg
The gross necropsy of the survivors revealed no observable abnormalities. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The estimated oral LD50 and 95% confidence limits of the test item is 1161 (550 to 2000) mg/kg
of body weight in female rats. - Executive summary:
The acute oral toxicity is performed using up and down procedure according to OECD Guideline 425 under GLP.
The estimated oral LD50 and 95% confidence limits of the test item is 1161 (550 to 2000) mg/kg of body weight in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 161 mg/kg bw
- Quality of whole database:
- reliable without restriction
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
Acute toxicity:
Oral, OECD 425: LD50 = 1161 (550 to 2,000) mg/kg body weight
Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1, this substance should be classified as Category 4.
Specific target organ toxicity-single exposure:
Oral:
For the died animals, the gross necropsy revealed red staining of the nose/mouth area, wetness and brown and gray staining of the anogenital area, darker than normal lungs, excess fluid in the pleural cavity, abnormalities of the gastrointestinal tract, distention of the stomach (white fluid), pale areas on the liver and red fluid in the bladder.
No abnormalities were noted at necropsy in survived animals.
As there were no effects considered to support classification for Category 1 and 2 observed. Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should not be classified.
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