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EC number: 200-772-0 | CAS number: 72-17-3
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
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- Endpoint summary
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2003-08-14 to 2003-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- magnesium;(2S)-2-hydroxypropanoate
- Cas Number:
- 132344-20-8
- Molecular formula:
- C6H10MgO6
- IUPAC Name:
- magnesium;(2S)-2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Magnesium-S-lactate
- Lot/batch No.: 0208001478
- Appearance: white powder
- Purity: >98%
- Expiry date: 01 September 2007
- Storage condition of test material: at room temperature in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: animals were individually housed on cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet, 100 g per day
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Each animal was treated by instillation of 49.2 mg (equivalent to 0.1 mL) test substance 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.
- Observation period (in vivo):
- After installation of the test-substance, animals were transferred to their cages, the animals were observed and any abnormalities recorded. Examination of the eyes was conducted at 1, 24, 48, and 72 hours after test-substance application.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to OECD 405
TOOL USED TO ASSESS SCORE: 2% fluorescein was instilled after the 24-hour observation time point into both eyes of each animal to quantitatively determine corneal epithelial damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The scores for eye irritation/corrosion are given in table 1 in box " Any other information on results incl. tables". Instillation of 49.2 mg of the test substance (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in two animals and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness and chemosis, which had completely resolved within 24 hours in two animals and within 48 hours in one animal. Finally, there was no evidence of ocular corrosion and also no staining of (peri) ocular tissues by the test substance.
- Other effects:
- 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: Results
Scored item and animal No. | Observation time | |||||||
Cornea | 1h | 24h | 48h | 72h | Mean 24/48/72h | |||
Rabbit 511 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 534 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 535 | 0 | 0 | 0 | 0 | 0 | |||
Iris | 1h | 24h | 48h | 72h | Mean 24/48/72h | |||
Rabbit 511 | 1 | 0 | 0 | 0 | 0 | |||
Rabbit 534 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 535 | 1 | 0 | 0 | 0 | 0 | |||
Redness | 1h | 24h | 48h | 72h | Mean 24/48/72h | |||
Rabbit 511 | 2 | 1 | 0 | 0 | 0.33 | |||
Rabbit 534 | 2 | 0 | 0 | 0 | 0 | |||
Rabbit 535 | 2 | 0 | 0 | 0 | 0 | |||
Chemosis | 1h | 24h | 48h | 72h | Mean 24/48/72h | |||
Rabbit 511 | 2 | 0 | 0 | 0 | 0 | |||
Rabbit 534 | 1 | 0 | 0 | 0 | 0 | |||
Rabbit 535 | 1 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- In a primary eye irritation study conducted according to OECD 405, Magnesium (S)-lactate was instilled into the conjunctival sac of the eye of three young adult New Zealand White rabbits. Based on the results, the test substance can be considered as non-irritating to the eye.
- Executive summary:
In a primary eye irritation study (OECD 405), 0.1 mL of Magnesium (S)-lactate was instilled into the conjunctival sac of one eye of each of three adult New Zealand White rabbits. Animals were observed for 7 days. Irritation was scored by the method of Draize. Only very mild conjunctival redness was observed in one rabbit, which were fully reversible within 48 hours. No signs of systemic intoxication was observed in any of the rabbits. Based on the results, the test item can be considered as not irritating.
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