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EC number: 240-926-4 | CAS number: 16891-37-5
- 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 / corrosion
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-03-02 to 2010-03-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to Guidelines in a GLP certified laboratory
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:
- other: OECD Guideline 431 (In vitro skin corrosion:Human skin model test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline 440 (Part B: Methods for determination of toxicity and other health effects, Guideline B.40 BIS "In vitro corrosion: Human skin model test"
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Self-Certified
Test material
- Reference substance name:
- Magnesium hydroxide
- EC Number:
- 215-170-3
- EC Name:
- Magnesium hydroxide
- Cas Number:
- 1309-42-8
- Molecular formula:
- H2MgO2
- IUPAC Name:
- magnesium dihydroxide
- Details on test material:
- Identification: Magnesium hydroxide
Molecular formula: Mg(OH)2
Molecular weight: 58.32
CAS Number: 1309-42-8
Stable under storage conditions: Stable
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: In vitro test with human skin model
- Details on test animals or test system and environmental conditions:
- Not applicable. In vitro test.
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: Skin tissue was moistened with 25ul of Milli-Q water to ensure close contact to the tissue
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg of magnesium hydroxide was applied directly on top of skin tissue which was moistened with 25 ul of Milli-Q water. - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Observation period:
- 3 minutes and 1 hour
- Number of animals:
- Not applicable
- Details on study design:
- Magnesium hydroxide was topically applied on a human three dimensional epidermal model. 25mg of Magnesium hydroxide was applied directly on top of the skin tissue which was moistened with 25µl of Milli-Q water.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Time point 3 minutes, max score 100
- Value:
- 88
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Time point 1 hour, max score 100
- Value:
- 95
Any other information on results incl. tables
Magnesium hydroxide was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that magnedium hydroxide did not interact with MTT.
The mean absorption at 540 nm measured after treatment with magnesium hydroxide and controls are presented in Table 1. Table 2 shows the mean tissue viability obtained after 3 minute and 1 hour treatments with magnesium hydroxide compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance.
A test substance is considered corrosive in the skin corrosion test if:
1. The relative mean tissue viability obtained after 3 minutes of treatment compared to the negative control tissues is decreased below 50 %.
2. The relative tissue viability after 1 hour of treatment is decreased below 15 %.
A test substance is considered to be non-corrosive if:
1. The relative mean tissue viability obtained after 3 minutes of treatment compared to the negative control tissues is above 50 %.
2. The relative tissue viability after 1 hour of treatment is not decreased below 15 % The relative mean tissue viability obtained after the 3 minute and 1 hour treatments with magnesium hydroxide compared to the negative control tissues were 88 % and 95 %, respectively. The absolute mean OD540 of the negative control tissues was within the historical control range. The mean relative tissue viability following 3 minutes and 1 hour of exposure to the positive control were 9 %. Therefore, it was concluded that the test system was suitable for this analysis. Table 1: Mean absorption in the in vitro skin corrosion test with magnesium hydroxide (OD540)
|
3 minute application |
1 hour application |
||||
|
A |
B |
Mean ± SD |
A |
B |
Mean ± SD |
Negative control |
1.683 |
1.699 |
1.691 ± 0.011 |
1.707 |
1.710 |
1.708 ± 0.002 |
Magnesium hydroxide |
1.586 |
1.393 |
1.490 ± 0.137 |
1.664 |
1.578 |
1.621 ± 0.061 |
Positive control |
0.150 |
0.143 |
0.147 ± 0.005 |
0.148 |
0.145 |
0.147 ± 0.002 |
Table 2: Mean tissue viability
|
3 minute application viability (% of control) |
1 hour application viability (% of control) |
Negative control |
100 |
100 |
Magnesium hydroxide |
88 |
95 |
Positive control |
9 |
9 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not corrosive
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the results of this study, it is concluded that magnesium hydroxide is not corrosive in the in vitro skin corrosion test.
- Executive summary:
The potential of magnesium hydroxide to induce skin corrision was tested using a human three-dimensional epidermal model. The possible corrosive potential of magnesium hydroxide was tested using topical application for either 3 minutes or 1 hour. Twenty five mg of magnesium hydroxide was added directly on top of the skin tissue which was moistened with water. Water and potassium hydroxide were used as the negative and positive control substances, respectively.
The positive control had a mean relative tissue viability of 9 % after 3 minutes exposure, and the absolute mean optical density of the negative control tissues was within the historical control range, indicating the acceptability of the assay.
The mean relative tissue viabilities for magnesium hydroxide after 3 minute and 1 hour treatments were 88 % and 95 %, respectively. Because the mean relative tissue viability for magnesium hydroxide was not below 50 % after the 3 minute treatment or 15 % after the 1 hour treatment, it was concluded that magnesium hydroxide is not corrosive under the conditions of this test.
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