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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal 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 animais were housed individually in suspended stainless steel cages.
Environment: The animal room temperature and relative humidity ranges were 65-70° F and 18-65%, 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
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal trunk after the fur was removed (on day 1)
- % coverage: 10% of the animal's body surface are
- Type of wrap if used :porous gauze dressing, which was backed by plastic wrap (occlusive binding)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, after removal of the dressing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24 hours
- Doses:
- 0.27; 0.55; 0.82 ml/kg bw (equivalent to 250, 500 and 750 mg/kg bw 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 : LD50 study animals were observed for clinical abnormalities a minimum of 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.
-Frequency of dermal observation: LD50 study animals were examined for erythema and edema following patch removal on study day 1 and daily thereafter (days 2-14) according to the Dermal Grading System
- lndividual body weights were obtained for the LD50 study animals prior to dosing on day 0 and for all surviving animais on days 7 and 14 and at the time of death for any animal dying on study.
- Necropsy of survivors performed: yes. All 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.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 446 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 378 - 526
- Mortality:
- All mortality occured day 4
- Clinical signs:
- other: at 250 mg/k: dark material around the mouth and urine stain and were noted on study days 0-1 and 0-2, respectively For the surviving animals in the 500 and 750 mg/kg dose levels, clinical abnormalities included decreased activity, which was noted in two
- Gross pathology:
- For animals that died: discolored kidneys and/or spleen, reddened thymus, abnormal content in the small intestine, stomach, and urinary bladder, mottled lungs, congested meningeal vessels, reddened mucosa in the urinary bladder and reddened cervical lymph nades
Any other information on results incl. tables
Dose |
Mortality in males |
Mortality in females |
Combined mortality |
250 |
0/5 |
0/5 |
0/10 |
500 |
3/5 |
5/5 |
8/10 |
750 |
4/5 |
5/5 |
9/10 |
|
LD50 |
95%Confidence Interval |
|
95% Confidence Interval |
Sex |
(mg/kg) |
(mg/kg) |
Slope |
Slope |
Male |
491.8 |
361.1 - 669.8 |
1.5 |
1.3-1.8 |
Female |
353.6 |
294.0 - 425.2 |
1.2 |
1.2-1.3 |
Combined |
446.3 |
378.5 - 526.3 |
1.4 |
1.3-1.5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the conditions of this test, the acute dermal LD50 of t-Amyl Hydroperoxide in the male rat was determined to be 491.8 mg/kg. ln the female rat, the dermal LD50 was determined to be 353.6 mg/kg. ln the sexes combined, the acute dermal LD50 was determined to be 446.3 mg/kg
- Executive summary:
An LD50 study was performed in which three groups of male and female rats received a single dermal administration of the test article at graded dosage levels. Following dosing, the LD50 study rats were observed daily and weighed weekly. A gross necropsy examination was performed on all LD50 study animals at the time of death or scheduled euthanasia (day 14).
All mortality occurred by study day 4. The majority of clinical observations were observed in the 500 mg/kg and 750 mg/kg dose levels. In these group, for the surviving animals, clinical abnormalities included decreased activity, wobbly gait, transient incidences of rough haircoat, dark material around the facial area, reddish colored urine, decreased defecation, urine stain, eye(s) appeared dark and decreased food consumption.
For the animals that died during the study, notable clinical abnormalities included reddish colored urine, urine stain, dark material around the facial area, eye(s) appear dark, lacrimation, eyelids partially closed, decreased activity, prostration, and fasciculation. Dermal irritation was also noted at the site of test article application.
The most notable gross internal findings were observed in the animals that died and included discolored kidneys and/or spleen, reddened thymus, abnormal content in the small intestine, stomach, and urinary bladder, mottled lungs, congested meningeal vessels, reddened mucosa in the urinary bladder and reddened cervical lymph nodes.
Under the conditions of this test, the acute dermal LD50 of t-Amyl Hydroperoxide in the male rat was determined to be 491.8 mg/kg. ln the female rat, the dermal LD50 was determined to be 353.6 mg/kg. ln the sexes combined, the acute dermal LD50 was determined to be 446.3 mg/kg.
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