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EC number: 221-140-0 | CAS number: 3010-96-6
- 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:
- February 22 - March 24, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study followed OECD guideline 425 and was conducted under GLP assurances
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2,2,4,4-tetramethylcyclobutane-1,3-diol, mixed isomers
- EC Number:
- 221-140-0
- EC Name:
- 2,2,4,4-tetramethylcyclobutane-1,3-diol, mixed isomers
- Cas Number:
- 3010-96-6
- Molecular formula:
- C8H16O2
- IUPAC Name:
- 2,2,4,4-tetramethylcyclobutane-1,3-diol
- Details on test material:
- The test substance, identified as 2,2,4,4-Tetramethyl-1,3-cyclobutanediol, Lot #X29601-54-5, was received on December 19, 2005 and was further identified with PSL Reference Number 051219-3H. The test substance consisted of white crystals and was stored at room temperature. Prior to use,
the test substance was ground in a coffee mill. Test article purity was 99.6%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test Animals
Sex: Female, nulliparous and non-pregnant.
Species/Strain: Rat, Sprague-Dawley derived, albino.
Age/Body weight: Young adult (10-11 weeks)/186-230 grams at experimental start.
Source: Received from Ace Animals, Inc., Boyertown, PA
Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was
changed at least three times per week.
Animal Room Temperature Range: 19-24°C
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 15-24 days
Food: Purina Rodent Chow #5012
Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing system.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test substance was ground then administered as a 40% w/w mixture in com oil using a stainless steel ball-tipped gavage needle attached to an
appropriate syringe. Due to the high volume of test mixture to be administered for the 5,000 mg/kg dose level (12.63 ml/kg), each animal's dose was divided into two approximately equal portions, administered two hours apart. Prior to each dosing, experimentally naive rats were fasted overnight by removing the feed from their cages.Feed was replaced approximately 3-4 hours after the final dosing. - Doses:
- 470, 1,500, 5,000 mg/kg
- No. of animals per sex per dose:
- 470: 2/sex
1,500: 4/sex
5,000: 3/sex - Control animals:
- no
- Details on study design:
- All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for up to 14 days after dosing. Body
weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing or after death. Necropsies were performedon all animals. - Statistics:
- The Acute Oral Toxicity (Guideline 425) Statistical Program (Weststat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations and/or LD50 and eonfidence limit calculations.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 500 mg/kg bw
- Mortality:
- 470: 0/2
1,500: 1/4
5,000: 3/3; All died within five hours of the test substance administration - Clinical signs:
- other: 470: There were no adverse pharmacologic effects, or abnormal behavior. 1,500: One female died within six hours of the test substance administration. Prior to death, this animal was hypoactive. Following administration, all survivors were hypoactive and o
- Gross pathology:
- 470: No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
1,500: Gross necropsy of the decedent revealed a red discoloration of the intestines. No gross abnormalities were noted for any of the euthanized
animals when necropsied at the conclusion of the 14-day observation period.
5,000: Gross necropsy of the decedents revealed a red discoloration of the intestines.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of 2,2,4,4-tetramethyl-1,3-cyclobutanediol is estimated to be 1,500 mg/kg of body weight in female rats with a 95% confidence interval of I ,043 mg/kg (lower) to 4,350 mg/kg (upper).
- Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for
2,2,4,4 -tetramethyl-1 ,3 -cyclobutanediol to produce toxicity from a single dose via the oral route. Under the conditions of this study, the acute oral LD50 of the test substance is estimated to be 1,500 milligrams per kilogram of body weight in female rats with a 95% confidence interval of 1,043 mg/kg (lower) to 4,350 mg/kg (upper). Based on the estimated LD50 of the test substance supplied by the sponsor (1,500 mg/kg), a Main Test was conducted using a default starting dose level of 470 mg/kg, which was administered to one healthy female rat by oral gavage. Following the Up and Down procedure, eight additional animals were dosed at levels of 470, 1,500, or 5,000 mg/kg. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once
daily for up to 14 days after dosing. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing or after death. Necropsies were performed on all animals. All low dose animals were healthy and active with no evidence of toxicity. Animals dosed with 1,500 mg/kg showed hypoactivity with one of four dying. No gross abnormalities were noted accept for red intestines in the one dead animal. All animals died at the 5,000 mg/kg dose showing clinical signs of hypoactivity with one exhibiting a hunched posture and piloerection, and all exhibited red colored intestines.
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