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EC number: 239-707-6 | CAS number: 15630-89-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test was carried out according to the Health Effects Test Guidelines of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 41-48 (August 1982) and following the conditions of GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Health Effects Test Guidelines of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 41-48 (August 1982)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium carbonate, compound with hydrogen peroxide (2:3)
- EC Number:
- 239-707-6
- EC Name:
- Disodium carbonate, compound with hydrogen peroxide (2:3)
- Cas Number:
- 15630-89-4
- Molecular formula:
- CH2O3.3/2H2O2.2Na
- IUPAC Name:
- tetrasodium hydrogen peroxide dicarbonate
- Details on test material:
- - Name of test material (as cited in study report): FB sodium percarbonate
- Physical state: white granules
- Analytical purity: sponsor assumes responsibility for purity and stability determinations (including under test conditions)
- Lot/batch No.: I2439101
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young adult rabbits were procured, maintained individually in screen-bottom cages in temperature- and humidity-controlled (64-78 °F, 33-65 % humidity), provided access to water ad libitum and a measured amount of High Fiber Rabbit Chow 5326, Purina Mills, Inc., and held for an acclimation period of at least 7 days.
Six acclimated animals, weighing from 2608 to 2914 g, were chosen at random for the test, treated and maintained during the observeation period as specified for the acclimation period. Within 24 hours before treatment the hair was clipped from the back and flanks of each animal.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- The test material was applied to the intact skin of each rabbit in the amount of 0.5 g and moistened with 0.9 % physiological saline.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 0.5; 24; 48; 72 and 96 hours and day 7 and 14 after patch removal
- Number of animals:
- 6
- Details on study design:
- The treated area was covered with a 2.5 x 2.5 cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap and secured with Elastoplast tape to provide a semiocclusive dressing. Collars were applied to restrain the test animals for the 4-hour exposure period.
After the exposure period, the patches were removed. The test site was washed using lukewarm water and disposable paper towels. The test materiaal was removed from the test sites as thoroughly as possible. Thirty minutes following removal of the test material, the degree of erythema and edema was read according to the Draize technique. Subsequent examinations were made at 24, 48, 72 and 96 hours and days 7 and 14 after patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 2.2
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.2
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 1
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0.2
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: very slight edema
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- The dermal application of the test material caused at least very slight erythema in all of the test animals and at least very slight edema in four of six test animals.
- Other effects:
- No other effects were reported.
Any other information on results incl. tables
Table 1: Individual dermal irritation scores.
Animal number |
Sex |
Hours after patch removal |
Days after patch removal |
|||||
4 |
24 |
48 |
72 |
96 |
7 |
14 |
||
Erythema |
||||||||
F30068 |
Male |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
F30069 |
Male |
2 |
1 |
1 |
1 |
1d |
0 |
0 |
F30070 |
Male |
2a,b |
2a,b |
2a,b |
2a,b |
2a,b |
1d |
0 |
F30071 |
Female |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
F30072 |
Female |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
F30073 |
Female |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
Edema |
||||||||
F30068 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F30069 |
Male |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
F30070 |
Male |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
F30071 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F30072 |
Female |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
F30073 |
Female |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
a – subcutaneous haemorrhaging
b – blanching
d – desquamation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Application of FB sodium percarbonate to rabbit skin under 4-hour semioccluded conditions resulted in slight to moderate erythema and edema reactions. Only one test animal had mean erythema and oedema scores of 2 from gradings at 24, 48 and 72 hours after patch removal. All other test animals had mean erythema and oedema scores of 1 or below from gradings at 24, 48 and 72 hours. The substance is therefore considered as non-irritating to the skin.
- Executive summary:
A skin irritation test was performed with sodium percarbonate applied to the skin of six female and male rabbits for 4 -hour semioccluded conditions in accordance with the Health Effects Test Guidelines of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 41-48 (August 1982) and following the conditions of GLP.
Only one test animal had mean erythema and oedema scores of 2 from gradings at 24, 48 and 72 hours after patch removal. All other test animals had mean erythema and oedema scores of 1 or below from gradings at 24, 48 and 72 hours. The substance is therefore considered as non-irritating to the skin.
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