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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal 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:
- - Name of test material: Ascorbic Acid
- CAS number: 50-81-7
- Analytical purity: > 99%
- Impurities (identity and concentrations): not specified
- Isomers composition: > 99% L-Ascorbic Acid
- Lot/batch No.: B 12014
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllingsdorf, Switzerland
- Age at study initiation: 14 (male) weeks to 15 weeks (female)
- Weight at study initiation: 2.3 (male), 2.2 - 2.3 kg (female)
- Housing: Stainless steel cages equipped with automatic cleaning and drinking system
- Water: ad libitium
- Diet: Pelleted standard Kliba 341, Batch 53/90 rabbit maintenance diet ("Kliba", Klingenthalmuehle AG, 4303 Kaiseraugst, Switzerland)
- Acclimatisation 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Remarks:
- shaved and abraded
- Vehicle:
- water
- Remarks:
- bi-distilled tap water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
0.5 g was applied to the intact and the abraded skin of the shaved area
VEHICLE: The test item was applied using bi-distilled water as vehicle. Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to dosing.
NEGATIVE CONTROL: Not performed
POSITIVE CONTROL: Not performed - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 - 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal fur, 10 x 10 cm
- Coverage: 3 x 3 cm
- Type of wrap if used: Surgical gauze, covered with filter paper and semi-occlusive dressing (dressing wrapped around abdomen and anchored with an elastic bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: With lukewarm tap water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS: 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and the test item
SCORING SYSTEM: Erythema, edema and primary dermal irritation index
- Method of calculation: Mean values and standard deviations were calculated whenever possible.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema 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 irritation response in any animal at any time noted. No destructions or irreversible alterations of the treated skin were observed. No corrosion effect was evident on the skin.
- Other effects:
- The body weight gain of all rabbits was similar. No acute clinical symptoms were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table: Skin irritation scores
Time period | Animal No. | Sex | Erythema | Edema | Cummulative score | Mean cummulative score | ||||
Intact | Abraded | Intact skin | Abraded skin | Intact skin | Abraded skin | Intact skin | Abraded skin | |||
1 hour | 42 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 |
43 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | |
44 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | |
24 hours | 42 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 |
43 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | |
44 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | |
48 hours | 42 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 |
43 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | |
44 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | |
72 hours | 42 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 |
43 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | |
44 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 |
M = male
F = female
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ascorbic acid is not irritating to the rabbit's skin.
- Executive summary:
The acute skin irritating property of ascorbic acid was tested in vivo according to the OECD test guideline 404 and under GLP conditions. Following a single treatment of intact (and abraded) rabbit skin with ascorbic acid (1.0 g/animal; 3 animals) under semi-occlusive patch for 4 hours, the treated sites were scored at 24, 48, and 72 hours after cessation of the treatment. No irritation was seen in any animal at any reading. The overall irritation score was therefore 0.0 (RCC, 1990). In summary, ascorbic acid caused no skin reactions and GHS criteria for classification are not met.
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