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EC number: 205-130-3 | CAS number: 134-11-2
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on eye irritation caused by chemicals in rabbits--II. Structure-activity relationships and in vitro approach to primary eye irritation of salicylates in rabbits.
- Author:
- Syoichoiroh Sugai, Kyoji MURATA, Tadaharu KITAGAKI, Isao TOMITA
- Year:
- 1 991
- Bibliographic source:
- Journal of Toxicological Sciences, 16, 111-130, 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize method
- Principles of method if other than guideline:
- The primary eye irritation potential of the test chemical was evaluated according to Draize method
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Salicylic acid
- EC Number:
- 200-712-3
- EC Name:
- Salicylic acid
- Cas Number:
- 69-72-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- salicylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report):Salicylic acid
- Molecular formula:C7H6O3
- Molecular weight:138.12 g/mole
-Substance type: organic
- Physical state: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or tissues and environmental conditions:
- SEX: female
Source: Takeo breeder (Shizuoka, Japan)
- Age at study initiation: no data available
- Weight at study initiation: 2.0 -2.4 kg
- Fasting period before study:no data available
- Housing: housed in metal cages (39*40*44 cm)
- Diet (e.g. ad libitum): RC4 diet (Oriental Yeast Co. Ltd, Tokyo , Japan), ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25±1 deg C
- Humidity (%): 55±5%
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light): constant 12 hours light: dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- not mentioned
- Observation period (in vivo):
- The eyes were examined and the grade of ocular lesions was recorded at 1,24,48,72,96 hours and 7,14,21 days after administration of test chemical
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: conjunctival sac of the left eye
Scoring System: corneal opacity, erythema, chemosis, secreta and iritis were recorded and classified under Draize method (Draize et.al, 1944)
The sum of values, recorded for cornea, conjunctiva and iris was divided by the number of observation times and the average scores (Draize scores) were used as grades of ocular irritation potential of the chemical
The maximum value of Draize score are as follows:
Cornea =80, Conjunctiva = 20 and Iris = 5
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 54.1
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 21 d
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: couldnot be determined due to corneal opacity
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 10.3
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The average Draize scores after 21 days was as follows: CORNEA = 54.1/80, iris = couldnot be determined, conjunctiva = 10.3/20.
Salicylic acid induced severe eye irritation not recovering within 21 days of treatment.
Any other information on results incl. tables
Table 1: Physchem Parameters and Primary Irritation Scores
Log P* |
Draize Scores |
||
Cornea |
Iris |
Conjunctiva |
|
2.32 |
54.1 (>21) |
-(-) |
10.3 (>21) |
*= Hansch and Leo, 1979, - = not evaluated due to corneal opacity
Figures in parenthesis indicate the days of recovery.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test chemical induced severe eye irritation not recovering within 21 days of treatment.
Hence, the test chemical can considered to be irritating to female Japanese White rabbit eyes. - Executive summary:
The primary eye irritation potential of the test chemical was evaluated according to Draize method.
3 female Japanese White rabbits (2.0-2.2 kg) were used for the study. The chemical (if solid= 100 mg, if liquid = 0.1ml) was instilled into the conjunctival sac of the left eye.Right eye (untreated eye) served as blank control.The eyes were examined and the grade of ocular lesions was recorded at 1, 24, 48, 72, 96 hours and 7,14,21 days after administration of test chemical.Corneal opacity, erythema, chemosis, secreta and iritis were recorded and classified under Draize method (Draize et.al, 1944).The sum of values, recorded for cornea, conjunctiva and iris was divided by the number of observation times and the average scores (Draize scores) were used as grades of ocular irritation potential of the chemical
The maximum value of Draize score are as follows: Cornea =80, Conjunctiva = 20 and Iris = 5
The average Draize scores after 21 days were as follows:CORNEA = 54.1/80, iris = could not be determined, conjunctiva = 10.3/20.
The test chemical induced severe eye irritation not recovering within 21 days of treatment.
Hence the test chemical can be assessed as irritating to rabbit eyes.
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