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EC number: 222-321-7 | CAS number: 3425-61-4
- 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
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- tert-pentyl hydroperoxide
- EC Number:
- 222-321-7
- EC Name:
- tert-pentyl hydroperoxide
- Cas Number:
- 3425-61-4
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2-methylbutane-2-peroxol
- Test material form:
- other: liquid
- Details on test material:
- t-Amyl Hydroperoxide,
Lot 5867422102
Receipt Date: October 3, 1994
Physical Description : Clear colorless liqui
Storage Conditions: Room temperature
Expiration Date:February 9, 1995
Density: 0.91 g/ml
Purity: 86.7 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adults rats were received at SLS from Charles River Laboratories, lnc., Portage, Michigan. 200 to 300 g prior to the study
Method of identification: Upon receipt, metal ear tags displaying unique identification numbers were used to individually identify the animais.
Housing: The animals were housed individually in suspended stainless steel cages.
Environment: The animal room temperature and relative humidity ranges were 63-71° F and 35-55%, respectively. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12-hour light/12-hour dark cycle. There were ten to twelve air changes in the animal room per hour. The animal room temperature and relative humidity were recorded a minimum of once daily.
Food and water ad libitum
Quarantine: 5 days at minimum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 0.27, 0.55 and 1.10 ml/kg (equivalent to 250, 500 and 1000 mg test mat./kg bw/day based on a density of 0.91)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: two times on study day 0 (postdose) and daily thereafter (days 1- 14). A mortality check was performed twice daily, in the morning and afternoon.
- Weighing: prior to fasting (day -1), prior to dosing on day 0 and for all surviving animals on days 7 and 14 and at the time of death for any animal dying on study.
- All study animals which died spontaneously during the study or were euthanized (carbon dioxide inhalation) at study termination (day 14) were necropsied. Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined. No tissues were retained.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 418 - 598
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 518 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 383 - 700
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 483 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 357 - 652
- Mortality:
- Dose Males Females Males/females
250 0/5 0/5 0/10
500 2/5 3/5 5/10
1000 5/5 5/5 10/10
Rats died at day 1 or 2 - Clinical signs:
- other: Salivation was present in all groups on study day 0 only. Abnormal breathing and urine stain were present in all groups on study days 0-2 (except for one animal in the 500 mg/kg dose group who had urine stain on study days. Decreased activity, dehydration
- Gross pathology:
- The most notable gross internal findings were observed in the animals that died and included congested meningeal vessels in the brain, mottled livers, abnormal contents in the digestive tract, smooth mucosa, linear striations and dark red foci in the stomach, reddened mucosa in the small intestines, dark red and thickened serosa in the stomach, discolored thymus, abnormally colored fluid contents in the urinary bladder and thoracic cavity and musculature and viscera in the whole body stained orange.
Any other information on results incl. tables
5/5
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this test, the acute oral LD50 of t-Amyl Hydroperoxide in the male rat was determined to be 518 mg/kg. ln the female rat, the oral LD50 was determined to be 483 mg/kg. ln the sexes combined, the oral LD50 was determined to be 500 mg/kg.
- Executive summary:
The Acute oral toxicity of tert-amyl hydroperoxide was evaluated in rats according a method similar to OECD N°401 guideline (Acute Toxic Standard Method), GLP study compliant. Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of tert-amyl hydroperoxide at doses of 0, 250, 500, 1000 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14) or when animals were found dead.
No mortality occurred in the lowest dose group. 5 animals died before day 2 after administration of 500 mg/kg (2 males and 3 females). All animals of the highest dose group died one day after oral administration of the substance. Clinical signs observed were [hypoactivity, salivation, piloerection, abnormal breathing, urine stain, wobbly gate] for most of animals; and tremor, prostration, apparent hypothermia in animals who died.
The most notable gross internal findings were observed in the animals that died and included congested meningeal vessels in the brain, mottled livers, abnormal finding in the digestive tract, discolored thymus, abnormally colored fluid contents in the urinary bladder and thoracic cavity and musculature and viscera in the whole body stained orange.
Under these experimental conditions, the oral LD50 of tert-amyl hydroperoxide is 500 mg/kg in Sprague Dawley rats (517 mg/kg in males, 483 mg/kg in females).
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