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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 October 2009 to 13 November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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
- GLP compliance:
- yes (incl. QA statement)
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: particulate/powder
- Details on test material:
- Sponsor's identification : MnO2
Purity : 97.6%
Batch number : 103721-02
Description : black powder
Date received : 8 September 2008
Storage conditions : room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Weight at study initiation: 2.33 to 2.67 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study
- Water: Free access to mains drinking water was allowed throughout the study
- Acclimation period: an acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70% respectively
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: tets material moistened with 0.5 mL distilled water to achieve a paste
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test material
- Concentration: At each test site a quantity of 0.5 g of the test material, moistened sufficiently with 0.5 mL of distilled water to achieve a paste - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm cotton gauze
- Type of wrap if used: a strip of surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours
SCORING SYSTEM:
Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 68623 Male
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Remarks:
- 68624 Male
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Remarks:
- 68663 Male
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Remarks:
- 68623 male
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Remarks:
- 68624 male
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Remarks:
- 68663 Male
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and oedema are given in Table 1 (all tables are in the any other information on results section). Black staining of the fur was noted at all treated skin sites. No evidence of skin irritation was noted during the study.
- Other effects:
- Individual bodyweights and bodyweight changes are given in Table 2. All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Individual Skin Reactions
Skin Reaction |
Observation |
Individual Scores – Rabbit Number and Sex |
Total |
||
68623Male |
68624Male |
68663Male |
|||
Erythema/Eschar Formation |
Immediately |
0STA |
0STA |
0STA |
(0 ) |
1 Hour |
0STA |
0STA |
0STA |
( 0 ) |
|
24 Hours |
0STA |
0STA |
0STA |
0 |
|
48 Hours |
0STA |
0STA |
0 |
( 0 ) |
|
72 Hours |
0STA |
0STA |
0 |
0 |
|
Oedema Formation |
Immediately |
0 |
0 |
0 |
( 0 ) |
1 Hour |
0 |
0 |
0 |
( 0 ) |
|
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
( 0 ) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72-hour Readings (S) : 0 |
|||||
Primary Irritation Index (S/6) : 0/6 = 0.0 |
|||||
Classification : NON-IRRITANT |
( ) = Total values not used for calculation of primary irritation index
STA = Black staining of the fur
Table 2: Individual Bodyweights and Bodyweight Changes
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 3 |
||
68623Male |
2.33 |
2.43 |
0.10 |
68624Male |
2.33 |
2.45 |
0.12 |
68663Male |
2.67 |
2.84 |
0.17 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not considered to be an irritant under the conditions of the study.
- Executive summary:
The skin irritation potential of the test material was investigated in vivo in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU Method B.4.
During the study no signs of skin irritation were noted at any of the observation points. The test material was therefore concluded to be a non-irritant.
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