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EC number: 215-170-3 | CAS number: 1309-42-8
- 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:
- weight of evidence
- Study period:
- 2010-04-22 to 2010-09-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000); including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material used in the report: Magnesium hydroxide
- Appearance: white powder
- Batch No.: 20BR0026
- Purity: 99.90%
- Storage: at room temperature in the dark
- Expiry date: 2012-01-31
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Belton, Leics, England
- Age at study initiation: Animals used within the study were at least 6 weeks old
- Weight at study initiation: Body weights were at least 1.0 kg
- Housing: Animals were individually housed in labelled cages with perforated floors and shelters.
- Diet: Pelleted diet for rabbits approximately 100 grams per day was provided at least three times a week.
- Water: Free access to tap water
- Acclimation period: Acclimitisation period was at least 5 days before start of treatment under laboratory conditions.
Results of analysis for diet, hay and water were assessed and did not reveal any findings that were considered to have affected the study integrity.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0±3.0°C
- Humidity (%): 40-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours darkness per day.
IN-LIFE DATES: From: 06-04-2010 to: 2-04-2010
Test system:
Amount/ concentration applied:
Animals were treated by instillation of on average, 57.3 mg (range 57.0-57.5 mg) of the test substance (a volume of approximately 0.1mL) in the conjunctival sac of one of the eyes.
Observation period:
Observations were made 1, 24, 48 and 72 hours after instillation.
Mortality/ Viability: Twice daily
Toxicity: At least once daily
Body weight: Day of treatment and after the final observation
Necropsy: No necropsy was performed according to protocol.
Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 57.3 mg (range 57.0 – 57.5 mg) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males were used in the treatment.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
no
SCORING SYSTEM:
See box: Any other information on materials ane methods incl. tables.
TOOL USED TO ASSESS SCORE: 2% fluorescein; Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Instillation of approximately 57 mg of Magnesium hydroxide into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of a slight dulling of the normal lusture and/or epithelial damage (maximum 10% of the corneal area) in two animals. The corneal injury had resolved within 24 or 48 hours. Iridial irritation grade 1 was observed in all animals and had resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 72 hours in all animals.
Coloration/ Remnants
Remnants of the test substance were present in the eye of two animals on Day 1.
Toxicity/ Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 1: Mean value eye irritation scores
|
Mean 24, 48 and 72 hours. |
|||
Animal |
Corneal opacity |
Iris |
Conjunctivae |
|
|
Redness |
Chemosis |
||
328 |
0.0 |
0.0 |
1.0 |
0.0 |
377 |
0.0 |
0.0 |
1.0 |
0.3 |
379 |
0.0 |
0.0 |
1.0 |
0.3 |
Table 2: Animal specifications
Animal |
Sex |
Age at start (weeks) |
Body weights( grams) |
|
|
|
|
Prior to application |
At termination |
328 |
Male |
10-12 |
2198 |
2256 |
377 |
Male |
7-9 |
1516 |
1701 |
379 |
Male |
7-9 |
1615 |
1739 |
Table 3: Individual Eye Irritation Scores
Cornea | Iris | Conjunctivae | |||||||
Animal No. | Time after dosing (hours) | Opacity (0-4) | Area (0-4) | Fluor area (%) | (0-2) | Redness (0-3) | Chemosis (0-4) | Discharge (0-3) | Comments |
1 | 1 | 0 | 0 | - | 1 | 1 | 1 | 1 | - |
24 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | - | |
48 | 0 | 0 | - | 0 | 1 | 0 | 0 | - | |
72 | 0 | 0 | - | 0 | 0 | 0 | 0 | - | |
2 | 1 | 0 | 1 | - | 1 | 1 | 2 | 1 | b g |
24 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | - | |
48 | 0 | 0 | - | 0 | 1 | 0 | 0 | - | |
72 | 0 | 0 | - | 0 | 0 | 0 | 0 | - | |
3 | 1 | 0 | 1 | - | 1 | 2 | 2 | 2 | b g |
24 | 0 | 1 | 10 | 0 | 2 | 1 | 1 | g | |
48 | 0 | 0 | - | 0 | 1 | 0 | 0 | - | |
72 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - |
Fluor area: Green staining after fluorescein treatment (percentage of total corneal area)
b Remnants of the test substance in the eye.
g Slight dulling of the normal luster of the cornea.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these results Magnesium hydroxide does not have to be classified and has no obligatory labelling requirement for eye irritation according to the GHS criteria.
- Executive summary:
In a primary eye irritation study conducted according to OECD guideline 405, 57 mg of magnesium hydroxide was instilled into the conjunctival sac of one of the eyes of 3 male rabbits without rinsing. Observations were made 1, 24, 48 and 72 hours after instillation. Irritation was scored by the method of Draize.
Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of slight dulling of the normal lustre and/or epithelial damage (maximum 10% of the corneal area) in two animals. The corneal injury had resolved within 24 or 48 hours. Iridial irritation grade 1 was observed in all animals and had resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 72 hours in all animals.
In this study, magnesium hydroxide is not an eye irritant based on GHS criteria.
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