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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 November 2009 to 19 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Limited, Hillcrest, Belton, Loughborough, UK
- Weight at study initiation: 2.31 to 2.82 kg
- Housing: The animals were individually housed in suspended cages
- Diet: Free access to mains drinking water and 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: of at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70% respectively
- Air changes (per hr): The rate of air exchange was at least fifteen 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL of the test material, which was found to weigh approximately 32 mg
- Concentration (if solution): A volume of 0.1 mL of the test material, which was found to weigh approximately 32 mg
VEHICLE
Not applicable - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- APPLICATION OF TEST SUBSTANCE:
Initially a single rabbit was treated with 0.1 mL (32 mg) of test material. The test material was administered into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment to prevent loss of test material and then released. The left eye served as a control and remained untreated. Immediately after administration of the test material an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
SCORING SYSTEM:
Assessment of ocular damage/irritation was made 1, 24, 48 and 72 hours post dosing using the scoring system from Draize JH (1977) “ Dermal and Eye Toxicity Tests” In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p. 48 to 49. Any other ocular effects were also noted at this point along with any clinical signs of toxicity if present. Individual bodyweights were recorded on day 0 and 3. The numerical values corresponding to each animal, tissue and observation time were recorded. These scores were then assessed using a modified version of the system described by Kay JH and Calandra JC (1962), J. Soc. Cosmet. Chem. 13, 281-289. If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Table 1 and Table 2 (all tables are in the any other information on results section).
Black staining of the fur was noted around all treated eyes throughout the study.
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment (score 2 for conjunctival redness and chemosis, respectively), with minimal conjunctival irritation noted at the 24-hour observation (score 1 for conjunctival redness and chemosis, respectively). All treated eyes appeared normal at the 48-hour observation. - Other effects:
- Individual bodyweights and bodyweight changes are given in Table 3. All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
68633 Male |
68650 Male |
68672 Male |
|||||||||
IPR= 2 |
IPR= 2 |
IPR= 2 |
||||||||||
Time After Treatment |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
CORNEA |
|
|
|
|
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
|
|
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
|
|
|
A = Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B = Chemosis |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
C = Discharge |
1Sf |
0Sf |
0Sf |
0Sf |
1Sf |
0Sf |
0Sf |
0Sf |
1Sf |
0Sf |
0Sf |
0Sf |
Score (A + B + C) x 2 |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
Total Score |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
IPR= Initial pain reaction
Sf = Black staining of the fur around treated eye
Table 2: Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number and Sex |
Individual Total Scores At: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
68633 Male |
10 |
4 |
0 |
0 |
68650 Male |
10 |
4 |
0 |
0 |
68672 Male |
10 |
4 |
0 |
0 |
Group Total |
30 |
12 |
0 |
0 |
Group Mean Score |
10.0 |
4.0 |
0.0 |
0.0 |
Table 3: Individual Bodyweights and Bodyweight Changes
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 3 |
||
68633Male |
2.31 |
2.37 |
0.06 |
68650Male |
2.82 |
2.85 |
0.03 |
68672Male |
2.55 |
2.57 |
0.02 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the test material was determined to be not irritating to eyes.
- Executive summary:
The eye 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 405 and EU Method B.5.
No corneal or iridial effects was noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation.
Therefore, under the conditions of the study the test material was determined to be not irritating to eyes.
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