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EC number: 273-728-1 | CAS number: 69012-28-8 By-product of the manufacture of ferromanganese alloy containing primarily oxides of aluminum, manganese and silicon.
- 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:
- 3 November 2009 to 13 November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- 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:
- 2 009
- Report date:
- 2009
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
- Details on test material:
- - Name of test material : FeMn slag
- Substance type: green/grey solid lumps
- Physical state: solid
- Composition of test material, percentage of components: MnO 34.62 %, SiO2 28.18 %, CaO 20.95 %, Al2O3 10.38 %, MgO 3.41 %, FeO 0.53 %, K2O 0.57 %, TiO2 0.24 %.
- Purity test date: 2-July-2008
- Storage condition of test material: 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
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.17 - 2.43 kg
- Housing: Individually housed in suspended cages
- Diet: 2030 Teklad Global Rabbit diet (Harlan Teklad, Blackthorn, Bicester, Oxon, UK) available ad libitum
- Water: Mains drinking water available ad libitum
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): A minimum of 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hour cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g of test material sufficiently moistened in 0.5 mL of distilled water to achieve a paste. - Duration of treatment / exposure:
- Animal were exposed for 4 hours
- Observation period:
- Animals were observed for 72 hours for skin reactions
- Number of animals:
- 3 animals in total (1 animal used in the initial test, with a further 2 animals in the main test)
- Details on study design:
- TEST SITE
- Area of exposure: The test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch
- Type of wrap if used: The trunk of each rabbit was wrapped in an elasticated corset
REMOVAL OF TEST MATERIAL
- Washing: Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours post administration of test material
SCORING SYSTEM: Draize JH (1959) “Dermal Toxicity” In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Associations of Food and Drug Officials of the United States, Austin, Texas p.46-59
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24 and 72 hours post dosing
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: Not applicable, no effects observed during the study.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material.
The test material produced a primary irritation index of 0.0.
Any other information on results incl. tables
Measurement of pH
The pH of the test material was determined prior to commencement of the study and found to be as follows:
Preparation |
pH Measurement |
||
immediately |
after 10 minutes |
after 20 minutes |
|
10 % w/w aqueous preparation of the test material |
8.9 |
9.6 |
9.6 |
Table 1: Individual Skin Reactions
Skin Reaction |
Observation Time (Following Patch Removal) |
Individual Scores – Rabbit Number and Sex |
Total |
||
68637 Male |
68638 Male |
68661 Male |
|||
Erythema/Eschar 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 |
|
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 included in calculating the primary irritation index
Table 2: Individual Bodyweights and Bodyweight Changes
Rabbit Number and Sex |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 3 |
||
68637 Male |
2.17 |
2.21 |
0.04 |
68638 Male |
2.37 |
2.43 |
0.06 |
68661 Male |
2.43 |
2.52 |
0.09 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin. No corrosive effects were noted.
- 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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