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EC number: 910-356-7 | CAS number: -
- 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 Jun. 28, 2006 to Dec. 06, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 FEB 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 31 JUL 1992
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- according to Principles on Good Laboratory Practice (OECD 1997) and TCCA-Good laboratory Practice Standards and Testing Guidelines (Notification No. 2006-04 issued by the National Institute of Environmental Research on Feb. 24, 2006)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Manganese dioxide
- EC Number:
- 215-202-6
- EC Name:
- Manganese dioxide
- Cas Number:
- 1313-13-9
- Molecular formula:
- MnO2
- IUPAC Name:
- Manganese dioxide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Supplier: Sigma-Aldrich Co.
- CAS No.: 1313-13-9
- lot/batch No.of test material: 03531AE
- Purity test date: Feb. 2006
- Purity: 99.99%
- Titration: 62% Mn (with KMnO4)
- Trace Analysis (in ppm): Na 45.1, Fe 31.9, Mg 12.3, Ca 5.0, Ag 4.1, Zn 3.8, Cr 1.6
- Apperance: Dark grey powder
VEHICLE
- Mixture of dimethylsulfoxide (DMSO) and sterilized distilled water (35:65, v/v)
- Lot No.: DMSO: DB18472DB/ sterilized distilled water: AAW5AI
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: pulverized test item was suspended and solubilized in vehicle solution
- concentration and homogeneous measurements: not conducted
FORM AS APPLIED IN THE TEST (if different from that of starting material): mixture with vehicle
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- Specific Pathogen Free (SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Orient Bio, Ltd.
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at delivery: 7-week old male and 9-week old female rats
- Weight at study initiation: males: 230.7-266.3 g and females: 201.4-229.6 g
- Quarantine and acclimation period: 6 days
- Housing: stainless wire-mesh cage (280W x 500L x 200H mm), 3 and 1 animal during acclimation and test period
- Diet (e.g. ad libitum): pelleted chow ad libitum (supplier: PMI Nutrition International Lot. no: APR 04 063)
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 50±10%
- Air changes (per hr): 10~20 times
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2006-07-07 To: 2006-07-27
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Mixture of dimethylsulfoxide (DMSO) and sterilized distilled water (35:65, v/v)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal, shaved 24 hours before application
- skin surface: 6 x 8 cm2
- Type of wrap if used: gauze (5 x 7 cm2)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Saline
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3 ml/kg BW according to body weight of animal on treatment day 8callculated with Path/Tox System)
- Constant volume or concentration used: yes
VEHICLE
- Lot/batch no. (if required): DMSO: DB18472DB / sterilized distilled water: AAW5AI - Duration of exposure:
- 24 hours
- Doses:
- The dose levels for the study were determined referring to the results of a preliminary study. No toxic signs on mortality, clinical signs, body weight changes and gross findings were at the 500, 1000, and 2000 mg/kg levels of the preliminary study. Therefore a limit dose level of 2000 mg/kg body weight was administered.
- No. of animals per sex per dose:
- 5 animals per sex and dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations (clinical signs and mortality): 1, 2, 3, 4, 5, and 6 hours after dosing and once a day from day 2 to day 15
- Frequency of weighing: before test item administration (Day 1) and on Day 2, 5, 8, and 15 after treatment
- Necropsy of survivors performed: yes, with special attention to all vital organs
- Statistics:
- the study results were analyzed using Path/Tox System (Version 4.2.2, Xybion Medical System Corporation, USA) according to the standard operation procedure of Korea Institute of Toxicology. The value of body weigt was presented by mean ± SD.
Results and discussion
- Preliminary study:
- No toxic signs on mortality, clinical signs, body weight changes and gross findings were observed in a preliminary study at 500, 1000, and 2000 mg/kg levels of test item.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths in any groups during the study period.
- Clinical signs:
- No abnormal clinical signs were observed in any groups during the study period.
- Body weight:
- Decreased body weights or suppressed body weight gains were observed on Day 2 in vehicle control group and 2000 mg/kg bw group of both sexes. Observed effects appeared to be caused by the stress given by taping for treatment, since it happened in both control and treatment group.
- Gross pathology:
- No treatment-related gross findings were observed in all animals.
Any other information on results incl. tables
Tabelle 1: Body weights of rats at day 15.
mg/kg bw | male (n=5) | female (n=5) |
0 |
339.8 ± 23.9 | 240.5 ± 7.4 |
2000 |
340.1 ± 10.8 | 254.5 ± 20.8 |
Data are presented as mean ± SD.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Single dermal application of the limit dose of 2000 mg test item per kg bw did not cause lethality in 5 male and 5 female SD rats during the 15 day observation period, resulting in a LD50 > 2000 mg/kg bw.
- Executive summary:
To evaluate the acute toxicity after a single dermal administration according to OECD Guideline 402 (limit test) and under GLP, the test item was administered semiocclusively to 2 groups of SD male and female rats (5 animals/group) at doses of 0 and 2000 mg/kg bw. Mortality, clinical signs, body weight changes and gross findings were continually screened for 15 days following the single dose. No treatment-related effects on mortality, clinical signs, body weight changes, and gross findings in SD rats treated with a single dermal dose of test item were observed. Therefore, the LD50 value of the test item was considered to be over 2000 mg/kg bw for both sexes of rats.
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