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EC number: 421-140-2 | 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:
- 23 April - 21 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Magnesium bis (2-ethylbutanoate)
- IUPAC Name:
- Magnesium bis (2-ethylbutanoate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Magnesium bis (2-ethylbutanoate)
- Substance type: White powder with crystals
- Physical state: Powder
- Purity: 94.0%
- Lot/batch No.: CTO-268
- Expiration date of the lot/batch: 31 January 2013
- Storage condition of test material: In refrigerator (2-8°C) in the dark
- General information: Incompatible materials: oxidizing agents
- Hygroscopic: Yes
- Volatile: No (Less than 8.0 x 10-4 Pa at 25°C)
- Test substance handling: Reactive to oxygen; store in well-sealed container
- pH: (1% in water, indicative range) 7.4-7.4
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: Animals used withihn the study were at least 6 weeks old (one animal 7-8 weeks, and two animals8-9 weeks).
- Weight at study initiation: Body weights were at least 1.0 kg (1700, 1755 and 1833 grams, respectively).
- Housing: Individually housed in cages with perforated floors.
- Diet: Free access to pelleted diet for rabbits (Global Diet 2030 Harlan Teklad, Italy). Hay and wooden sticks were available during the study period.
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle.
IN-LIFE DATES: From: 23 April - 21 May 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied:
53.8 mg (range 53.4 – 54.0 mg) - Duration of treatment / exposure:
- Single instillation on Day 1.
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 and/or 14 days after instillation of the test substance
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- STUDY DESIGN
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 3 weeks later, after considering the degree of eye irritation observed in the first animal.
TREATMENT
Animals were treated by instillation of, on average, 53.8 mg (range 53.4 – 54.0 mg) of the test substance (a volume of approximately 0.1 mL), in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area. After the final observation, the animals were sacrificed by intra-venous injection of Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands).
REMOVAL OF TEST SUBSTANCE
-Washing: No
OBSERVATIONS
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to instillation) and after the final observation. For one animal also on Day 8 next to measurement after the final observation on Day 15. Evaluation: Provides additional information..
- Necropsy: No necropsy was performed according to protocol.
- Irritation:
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 and/or 14 days after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
The irritation scores and a description of all other (local) effects were recorded.The irritation was assessed according to OECD 405.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Instillation of approximately 54 mg of Magnesium bis (2-ethylbutanoate) (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae.
The corneal injury consisted of slight dulling of the normal luster on Day 1 for all animals. No corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. Iridial irritation (grade 1 or 2) was observed for two animals on Day 1 and for one animal at 1, 24, 48 and 72 hours after instillation. One of the animals showed absence of reactivity to light and reduced size of the pupil at 24, 48 and 72 hours after instillation. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 7 days. Bald skin around the eye was noted for one animal between 24 hours and 7 days after instillation. - Other effects:
- Colouration/Remnants:
No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.
Toxicity/Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- other: Irritating to eyes, but insufficient for classification.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results, Magnesium bis (2-ethylbutanoate) does not have to be classified and has no obligatory labelling requirement for eye irritation according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011)
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
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