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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1996-06-04 to 1996-09-20
- 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:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Version / remarks:
- Toxic Substances Control Act Test Guidelines, 40 CFR Part 798, Subpart B, Section 798.1100, July 1, 1992.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals, Section 4, Health Effects, Subsection 402, February 24, 1987.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- The EEC Guidelines Part B: Methods for the Determination of Toxicity, No. L 383 A/121, B.3, December 29, 1992.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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
- Age at study initiation: young adults
- Weight at study initiation: males: 264 - 351 g; females: 221 - 243 g
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rodent Chow #5002 (Purina Mills, Inc.) was provided ad libitum to the animals throughout the study.
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 20.5 °C (59 - 69 °F)
- Humidity (%): 52 - 80
- Air changes (per hr): 10- 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the dorsal trunk area of the animals, the fur was shaved and the area was clipped
- % coverage: ≥ 10% of the animal's body surface area (BSA)
- Type of wrap: an appropriately sized 4 ply porous gauze dressing, a plastic wrap and an elastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test article was removed using gauze moistened with distilled water followed by dry gauze.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 4 mL/kg
- Concentration: 2000 mg/kg - Duration of exposure:
- 24 h exposure, 14 days observation after exposure
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were obtained for the limit test animals prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed:
= clinical signs: Limit test animals were observed for clinical abnormalities a minimum of two times on study day 0 (postdose) and daily thereafter (days 1-14). A general health/mortality check was performed twice daily.
= dermal observations: Limit test animals were examined for erythema and edema following patch removal on study day 1 and daily thereafter (days 2-14) according to the Macroscopic Dermal Grading System based on Draize. The dermal test sites were reclipped as necessary to allow clear visualization of the skin. - Statistics:
- Data from the limit test were analyzed and an LD50 value estimated as follows:
< 50% Mortality: LD50 was estimated as greater than the administered dose.
= 50% Mortality: LD50 was estimated as equal to the administered dose.
> 50% Mortality: LD50 was estimated as less than the administered dose.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the limit test.
- Clinical signs:
- other: The most notable clinical abnormalities observed during the study included dark material around facial area, and urine stain. Dermal irritation was noted at the site of test article application.
- Gross pathology:
- No significant gross internal findings were observed at necropsy on study day 14.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the acute dermal LD50 of the test item was estimated to be greater than 2000 mg/kg in the rat.
- Executive summary:
The single-dose dermal toxicity of the test item was evaluated on Sprague-Dawley rats. A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test item at a dose of 2000 mg/kg body weight. Following dosing, the rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of death or scheduled euthanasia (day 14).
No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included dark material around facial area, and urine stain. Dermal irritation was noted at the site of test article application. Body weight gain was noted for all animals during the test period. No significant gross internal findings were observed at necropsy on study day 14.
Under the conditions of this test, the acute dermal LD50 of the test item was estimated to be greater than 2000 mg/kg in the rat.
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