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EC number: 205-126-1 | CAS number: 134-03-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ascorbic acid
- EC Number:
- 200-066-2
- EC Name:
- Ascorbic acid
- Cas Number:
- 50-81-7
- Molecular formula:
- C6H8O6
- IUPAC Name:
- 5-(1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5H)-one (non-preferred name)
Constituent 1
- Specific details on test material used for the study:
- CAS number: 50-81-7
Purity: >99%
Batch number: not reported
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Fuellinsdorf
- Age at study initiation: 18 (males) to 19 (females) weeks
- Weight at study initiation: 3.1 – 3.2 kg (males), 3.1 – 3.4 kg (females)
- Housing: Individual stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: Pelleted standard Kliba 341 ad libitium, Batch 53/90 rabbit maintenance diet ("Kliba", Klingenthalmuehle AG, 4303 Kaiseraugst, Switzerland)- Water (e.g. ad libitum):
- Acclimation period: 4 days under test conditions after veterenary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: Saturated solution and 1:3 dilution of saturated solution - Duration of treatment / exposure:
- 72 hours (not rinsed)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male, 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not rinsed
SCORING SYSTEM: According to the OECD TG, adopted February 24, 1987; corneal irritation, iridic irritation and conjunctival irritation
TOOL USED TO ASSESS SCORE: Hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 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 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 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 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corrosion of the cornea was observed at any of the measuring intervals.
- Other effects:
- One hour after instillation of the substance in the eye, conjunctival redness (score 1) was observed in all animals. No further signs of irritation were noted after 1 hour. Conjunctival redness was still observed at the 24-hour obervation point in one animal. No signs of irritation were seen thereafter.
Any other information on results incl. tables
Table 1: Eye Irritation Scores (saturated solution)
Animal | Sex | Rinsing | Cornea opacity | Iris | Conjunctivae | Cumulative score | Mean cumulative score | |
redn. | chem. | |||||||
1 hour | ||||||||
1 | M | not rinsed | 0 | 0 | 1 | 0 | 1 | 1.00 |
2 | M | not rinsed | 0 | 0 | 1 | 0 | 1 | |
3 | M | not rinsed | 0 | 0 | 1 | 0 | 1 | |
24 hours | ||||||||
1 | M | not rinsed | 0 | 0 | 1 | 0 | 1 | 0.33 |
2 | M | not rinsed | 0 | 0 | 0 | 0 | 0 | |
3 | M | not rinsed | 0 | 0 | 0 | 0 | 0 | |
48 hours | ||||||||
1 | M | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
2 | M | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
3 | M | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
72 hours | ||||||||
1 | M | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
2 | M | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
3 | M | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
M = male
F = female
Table 2: (diluted solution)
Animal | Sex | Rinsing | Cornea opacity | Iris | Conjunctivae | Cumulative score | Mean cumulative score | |
redn. | chem. | |||||||
1 hour | ||||||||
4 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
5 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | |
6 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | |
24 hours | ||||||||
4 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
5 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | |
6 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | |
48 hours | ||||||||
4 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
5 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | |
6 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | |
72 hours | ||||||||
4 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | 0.00 |
5 | F | not rinsed | 0 | 0 | 0 | 0 | 0 | |
6 | F | not rinsed | 0 | 0 | 0 | 0 | 0 |
M = male
F = female
Animal 4 and 6 slightly lost weight during the treatment period. The body weight gain of the remaining rabbits was unaffected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Slight and reversible signs of irritation were seen within the first 24 hours after treatment with ascorbic acid. The effects were fully reversible within 48 hours. GHS criteria for classification are not met.
- Executive summary:
In an OECD 405 study conducted under GLP conditions using 6 rabbits, the test material (ascorbic acid; saturated aqueous solution) was applied into the conjunctival sac of the rabbit eyes. The eyes were examined and reactions were scored at 1, 24, 48, and 72 hours after treatment. The mean overall irritation score was 1.0 at 1 h and 0.33 at 24 h. The effects were fully reversible within 48 hours, i.e. the irritation score was 0.0 (RCC, 1990).
The GHS criteria for classification of ascorbic acid were not met.
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