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EC number: 204-611-5 | CAS number: 123-23-9
- 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:
- from 1996-06-04 to 1996-09-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals, Section 4, Health Effects, Subsection 401, February 24, 1987.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- The EEC Guidelines Part B: Methods for the Determination of Toxicity, No. L 383 A/110, B.1, December 29, 1992.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Version / remarks:
- Toxic Substances Control Act Test Guidelines, 40 CFR Part 798, Subpart B, Section 798.1175, July 1, 1992.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-dioxo-4,4'-dioxydibutyric acid
- EC Number:
- 204-611-5
- EC Name:
- 4,4'-dioxo-4,4'-dioxydibutyric acid
- Cas Number:
- 123-23-9
- Molecular formula:
- C8H10O8
- IUPAC Name:
- 4-[(3-carboxypropanoyl)peroxy]-4-oxobutanoic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot No.: 0998603612
Purity: 59.6 %
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD®BR VAF/Plus®
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, Michigan, USA
- Females nulliparous and non-pregnant: yes
- Housing: individually in suspended stainless steel cages
- Weight at study initiation: males: 212 - 242 g; females: 216 - 241 g
- Age at study initiation: young adults
- Fasting period before study: overnight
- Diet: PMI Certified Rodent Chow #5002 (Purina Mills, Inc.) was provided ad libitum to the animals throughout the study (except during fasting).
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21 °C (60 - 70 °F)
- Humidity (%): 52 - 71
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Single oral dose application. The test item was applied in its initial form.
- Doses:
- 2000, 3500 and 5000 mg/kg
- No. of animals per sex per dose:
- 5 females and 5 males per dose
- Control animals:
- no
- Details on study design:
- Oral application on day 0. Post-dose observational period - 14 days.
- Statistics:
- The LD50 and 95% confidence intervals were calculated separately for males, females and the combined sexes using a computer adaption of the method of Litchfield and Wilcoxon.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 256.8 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 537.8 - <= 4 179.4
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 645.8 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 279.5 - <= 3 070.8
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 099.8 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 707.6 - <= 3 548.9
- Mortality:
- Four males and five females died in both the 3500 and 5000 mg/kg dose groups. All mortality occurred by study day 6.
- Clinical signs:
- other: The most notable clinical abnormalities observed during the study in both the animals that died and those that survived included decreased activity, breathing abnormalities, decreased to no defecation, piloerection, hunched posture, rough haircoat, dehydr
- Gross pathology:
- The most notable gross internal findings were observed in the animals that died and included abnormal contents, discoloration and thickened mucosa in the digestive tract, reddened thymus, abnormal and discolored contents in the trachea, abnormal contents in the urinary bladder, discolored lungs, livers and pancreas and congested meningeal vessels in the brain. No significant gross internal findings were observed at necropsy on study day 14, however single incidences of dilated pelvis of the kidney, gray raised area(s) on the spleen, thickened stomach mucosa and adhesion on the abdominal cavity were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the acute oral LD50 of the test item in the male rat was determined to be 3257 mg/kg. If the rat were female, the oral LD50 was determined to be 2646 mg/kg. In the sexes combined, the oral LD50 was determined to be 3100 mg/kg.
- Executive summary:
The single-dose oral toxicity of Succinic Acid Peroxide was evaluated in Sprague-Dawley rats. An LD50 study was performed in which three groups of five male and five female rats received a single oral 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). Mortality occurred during the LD50 study in dose levels 3500 and 5000 mg/kg - 4 males and 5 females died ind each dose group. All mortality occurred by study day 6.
The most notable clinical abnormalities observed during the study in both the animals that died and those that survived included decreased activity, breathing abnormalities, decreased to no defecation, piloerection, hunched posture, rough haircoat, dehydration, dark material around facial area, low food consumption, lacrimation, and feces small in size. Fecal/urine stain and distended abdomen were noted only in the surviving animals. Additional clinical abnormalities noted in the animals that died only included prostration, apparent hypothermia, extremities pale in color, cyanosis, wobbly gait and eyelids partially closed. Salivation was also noted on day 0 only in both the animals that survived and those that died and was probably related to the irritant nature of the test article. Body weight loss was noted in one 2000 mg/kg female during the day 0 to 7 body weight interval. Body weight gain was noted for all other surviving animals during the test period. The most notable gross internal findings were observed in the animals that died and included abnormal contents, discoloration and thickened mucosa in the digestive tract, reddened thymus, abnormal and discolored contents in the trachea, abnormal contents in the urinary bladder, discolored lungs, livers and pancreas and congested meningeal vessels in the brain. No significant gross internal findings were observed at necropsy on study day 14, however single incidences of dilated pelvis of the kidney, gray raised area(s) on the spleen, thickened stomach mucosa and adhesion on the abdominal cavity were noted.
Under the conditions of this test, the acute oral LD50 of Succinic Acid Peroxide in the male rat was determined to be 3257 mg/kg. If the female rat, the dermal LD50 was determined to be 2646 mg/kg. In the sexes combined, the dermal LD50 was determined to be 3100 mg/kg.
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