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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1996-06-04 to 1996-08-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- 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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: approximately 2.0 to 3.5 kg
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rabbit Chow #5322 (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): 18.9 - 21.7 °C (66 - 71 °F)
- Humidity (%): 56 - 78
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g / 100 % concentration
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 14 days after removing the gauze
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: the dorsal area of the trunk
- % coverage: approximately 1 inch x 1 inch
- Type of wrap: 1 x 1 inch square 4-ply gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: after 4 hours of exposure; cleaned with wet gauze and then with dry
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours up to 14 days after patch removal
SCORING SYSTEM:
- Method of calculation: Macroscopic Dermal Grading System based on Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Exposure to the test article produced moderate edema and moderate to severe blanching on 6/6 test sites at the 1 hour scoring interval. Additional dermal findings of eschar exfoliation and desquamation which were noted on 4/6 and 5/6 test sites, respectively and apparent necrosis and eschar which were noted on 6/6 test sites. The dermal irritation resolved completely in 1/6 animals by study day 14.
Under the conditions of this test, the test item is considered to be a corrosive to the skin of the rabbit. - Other effects:
- Apparant necrosis in different formations were observed.
Any other information on results incl. tables
As the observed erythema effect were more severe than the scorring scale allows to be classified, an additional score was added M-4 (= 5) which represented the most severely affected areas - injuries in depth. When this score was assigned additionally the type of injuries were described.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- It was determined that the test item corrosive to skin.
- Executive summary:
The potential irritant and/or corrosive effects of the test item were evaluated on the skin of New Zealand White rabbits in a study performed according to OECD 404, EC Regulation 124/92 method B.4 and EPA OPPTS 798.4470. Each of six rabbits received a 0.5 g dose of the test article as a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with distilled water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 14 days following patch removal.
Exposure to the test article produced moderate edema and moderate to severe blanching on 6/6 test sites at the 1 hour scoring interval. Additional dermal findings included eschar exfoliation and desquamation which were noted on 4/6 and 5/6 test sites, respectively, and apparent necrosis and eschar which were both noted on 6/6 test sites. The dermal irritation resolved completely in 1/6 animals by study day 14.
Under the conditions of this test, the test item is considered to be a corrosive to the skin of the rabbit.
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