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EC number: 203-148-6 | CAS number: 103-82-2
- 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:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from NTRL Reports
Data source
Referenceopen allclose all
- Reference Type:
- other: Secondary Literature
- Title:
- INITIAL SUBMISSION: ACUTE EYE IRRITATION IN RABBITS WITH COVER LETTER DATED 12/19/1997
- Author:
- NTRL
- Year:
- 1 997
- Bibliographic source:
- OTS0559218, 1997
- Reference Type:
- review article or handbook
- Title:
- RTECS Number : AJ2430000
- Author:
- RTECS Database
- Year:
- 2 012
- Bibliographic source:
- RTECS (Registry of Toxic Effects of Chemical Substances):NTIS** National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. Volume(issue)/page/year: OTS0559218
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: O.E.C.D. 405(24th February, 1987) and E.C. (92/69/E.E.C, B5- 31st July, 1992) Guidelines
- Principles of method if other than guideline:
- The potential of the test chemical to induce ocular irritation was evalualed in rabbits according to O.E.C.D. 405(24th February, 1987) and E.C. (92/69/E.E.C, B5- 31st July, 1992) Guidelines
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Phenylacetic acid
- EC Number:
- 203-148-6
- EC Name:
- Phenylacetic acid
- Cas Number:
- 103-82-2
- Molecular formula:
- C8H8O2
- IUPAC Name:
- phenylacetic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material: Benzeneacetic acid
- Molecular formula: C8H8O2
- Molecular weight: 136.149 g/mole
- Smiles : c1(ccccc1)CC(O)=O
- Inchl: 1S/C8H8O2/c9-8(10)6-7-4-2-1-3-5-7/h1-5H,6H2,(H,9,10)
- Substance type: Organic
- Physical state: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex:Male
- Source: Elevage Cunicole de Val de Selle. 80160 Prouzel. France
- Age at study initiation: no data
- Weight at study initiation: 2.7 ± 0.2 kg
- Housing: The animals were housed individually in polystyrene cages
- Diet (e.g. ad libitum): 112 C pelleted diet
- Water (e.g. ad libitum): Drinking water filtered by a EG. Millipore membrane (0.22 micron) was provided ad libitwn.
- Acclimation period: at least five days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour of filtered. non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 h112 h
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- The test substance was used in its original form. A single dose of 100 mg of the test substance was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test substance.
- Observation period (in vivo):
- Ocular reactions were observed approximately one hour, 24, 48 and 72 hours after the administration and then daily until the end of the study (day 22).
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): NO, The eyes were not rinsed after administration of the test substance.
- Time after start of exposure: NO
SCORING SYSTEM: Draize scale
Interpretation of the results:
Criteria for irritation
A substance or a preparation is considered irritant for the eyes if. when applied to the eye of the animal. significant severe ocular lesions are caused within 72 hours after exposure and which
persist for 24 hours or more after treatment with the test substance. All the scores at each reading time (24. 48 and 72 hours) and for an effect are used by calculating the respective mean values.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2.3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3.3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 48,72 hours
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2.7
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Slight to severe conjunctival reactions were observed in all animals: very slight to severe chemosis (grades 1 to 4). very slight to moderate redness of the conjunctivae (grade 1 to 3) and clear or whitish purulent discharge were noted. from day 1 up to day 17 at the latest.
A slight iritis (grade 1) was observed in two animals on day 2; it persisted up to day 12 or 14. Reading was masked by corneal opacity in the remaining animal.
A moderate or severe corneal opacity (grade 3 or 4) was noted in all animals on day 1: a slight to severe corneal opacity (grades 2 to 4) persisted up to the end of the observation period (day 22) in two animals. The remaining animal was killed on day 7 for ethical reasons, because of the severity of ocular reactions.
A whitening of the conjunctivae was noted in all animals on day 1; it persisted up to day 17 at the latest. Neovascularisation was noted in two animals from day 5 up to day 14 or from day 7 up to the end of the observation period (day 22) and alopecia around the eye was recorded in one animal, from day 11 up to day 20.
Any other information on results incl. tables
Individual ocular examinations and mean values of the scores recorded at each readings (24, 48 and 72 hours) for each animal
Rabbit number |
Region of the eyes |
Description of the ocular reactions |
Scores |
Mean irritation score
|
Interpretation (+)(-) |
|||
1h D1 |
24h |
48h |
72h |
|||||
1 |
Conjunctivae |
chemosis |
3 |
4 |
3 |
3 |
3.3 |
+ |
Redness |
2 |
3 |
3 |
3 |
3 |
+ |
||
Discharge |
2 |
S |
S |
S |
(2) |
|
||
Iris |
|
0 |
1 |
1 |
1 |
1 |
+ |
|
Corneal opacity |
intensity |
3 |
2 |
2 |
2 |
2 |
+ |
|
Area |
2 |
4 |
4 |
3 |
3.7 |
|
||
other |
|
B |
B |
B |
B |
|
|
|
Fluorescein |
|
/ |
U |
U |
U |
|
|
|
2 |
Conjunctivae |
chemosis |
3 |
3 |
3 |
3 |
3.0 |
+ |
Redness |
1 |
2 |
3 |
3 |
2.7 |
+ |
||
Discharge |
0 |
S |
S |
S |
(2) |
|
||
Iris |
|
OP |
OP |
OP |
OP |
(2) |
(2) |
|
Corneal opacity |
intensity |
4 |
4 |
4 |
4 |
4 |
+ |
|
Area |
1 |
2 |
2 |
3 |
2.3 |
|
||
other |
|
B |
B |
B |
B |
|
|
|
Fluorescein |
|
/ |
U |
U |
U |
|
|
|
3 |
Conjunctivae |
chemosis |
2 |
3 |
3 |
3 |
3 |
+ |
Redness |
2 |
3 |
3 |
3 |
3 |
+ |
||
Discharge |
0 |
S |
S |
S |
(2) |
|
||
Iris |
|
0 |
1 |
1 |
1 |
1 |
+ |
|
Corneal opacity |
intensity |
4 |
3 |
2 |
2 |
2.3 |
+ |
|
Area |
2 |
2 |
2 |
2 |
(2) |
|
||
other |
|
B |
B |
B |
B |
|
|
|
Fluorescein |
|
/ |
U |
U |
U |
|
|
(1) = mean of scores on days 2, 3 and 4
h = hour
D = day
(+) = irritant according to EEC criteria
(-) = Non-irritant according to EEC criteria
(2) = not calculated.
U = Fluorescein batches Nos. 5691 and 7239
I = Fluorescein not used
S = Whitish purulent discharge
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Slight to severe conjunctival reactions were observed in all animals: very slight to severe chemosis (grades 1 to 4). very slight to moderate redness of the conjunctivae (grade 1 to 3) and clear or whitish purulent discharge were noted. from day 1 up to day 17 at the latest.
A slight iritis (grade 1) was observed in two animals on day 2; it persisted up to day 12 or 14. Reading was masked by corneal opacity in the remaining animal.
A moderate or severe corneal opacity (grade 3 or 4) was noted in all animals on day 1: a slight to severe corneal opacity (grades 2 to 4) persisted up to the end of the observation period (day 22) in two animals. The remaining animal was killed on day 7 for ethical reasons, because of the severity of ocular reactions.
Based on these observations, the test chemical was considered to be severely irritating to rabbit eyes.
A whitening of the conjunctivae was noted in all animals on day 1; it persisted up to day 17 at the latest. Neovascularisation was noted in two animals from day 5 up to day 14 or from day 7 up to the end of the observation period (day 22) and alopecia around the eye was recorded in one animal, from day 11 up to day 20. - Executive summary:
The potential of the test chemical to induce ocular irritation was evaluated in rabbits according to O.E.C.D. 405(24th February, 1987) and E.C. (92/69/E.E.C, B5- 31st July, 1992) Guidelines. 3 Male New Zealand White rabbits were used for the study. The test substance was used in its original form. A single dose of 100 mg of the test substance was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye which remained untreated, served as a control. The eyes were not rinsed after administration of the test substance.
The eyes were examined approximately one hour, 24, 48 and 72 hours after administration of the test substance following the O.E.C.D. and E.C. guidelines:
· when there is no evidence of irritation after 1 hours. The study is ended.
· when there is persistent ocular irritation after 72 hours, the observation period is extended to a maximum of 21 days (until day 22) in order to determine the progress of the lesions and their reversibility.
· when severe irritant effects are observed, the animals are killed on humane ground.
Any change in the animals' behaviour was noted. Ocular reactions were observed approximately one hour, 24, 48 and 72 hours after the administration and then daily until the end of the study (day 22).
Slight to severe conjunctival reactions were observed in all animals: very slight to severe chemosis (grades 1 to 4). Very slight to moderate redness of the conjunctivae (grade 1 to 3) and clear or whitish purulent discharge were noted from day 1 up to day 17 at the latest.
A slight iritis (grade 1) was observed in two animals on day 2; it persisted up to day 12 or 14. Reading was masked by corneal opacity in the remaining animal.
A moderate or severe corneal opacity (grade 3 or 4) was noted in all animals on day 1: a slight to severe corneal opacity (grades 2 to 4) persisted up to the end of the observation period (day 22) in two animals. The remaining animal was killed on day 7 for ethical reasons, because of the severity of ocular reactions.
A whitening of the conjunctivae was noted in all animals on day 1; it persisted up to day 17 at the latest. Neovascularisation was noted in two animals from day 5 up to day 14 or from day 7 up to the end of the observation period (day 22) and alopecia around the eye was recorded in one animal, from day 11 up to day 20.
Based on these observations, the test chemical was considered to be severely irritating to rabbit eyes.
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