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EC number: 202-876-1 | CAS number: 100-66-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 31/05/1994 to 08/07/1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. The purity of the test substance is not indicated.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Anisole
- EC Number:
- 202-876-1
- EC Name:
- Anisole
- Cas Number:
- 100-66-3
- Molecular formula:
- C7H8O
- IUPAC Name:
- anisole
- Test material form:
- other: colourless liquid, stored at room temperature
- Details on test material:
- - Name of test material (as cited in study report): Anisole
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other: The pH of the test substance was irrelevant.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
- Age at study initiation: no data
- Weight at study initiation: 2.9 +/- 0.2 kg
- Housing: individually
- Diet (e.g. ad libitum): 112 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12hrs dark/ 12 hrs light
IN-LIFE DATES: From: To: no data
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
- Concentration (if solution): not applicable
VEHICLE: none - Duration of treatment / exposure:
- Not rinsed
- Observation period (in vivo):
- Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after administration of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not applicable
SCORING SYSTEM:
Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
- no swelling . 0
- any swelling above normal (includes nictitating membranes) ....................................................................................1
- obvious swelling with partial eversion of lids ................................................................................................................2
- swelling with lids about half-closed ................................................................................................................................3
- swelling with lids more than half-closed ........................................................................................................................4
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
- blood vessels normal .........................................................................................................................................................0
- a number of blood vessels definitely hyperemic (injected) .........................................................................................1
- diffuse, crimson colour, individual vessels not easily discernible .............................................................................2
- diffuse, beefy red ................................................................................................................................................................3
Discharge
- absence of discharge .........................................................................................................................................................0
- slight discharge (does not include small amounts normally found in inner canthus) ............................................1
- discharge with moistening of lids and hairs adjacent to lids .......................................................................................2
- discharge with moistening of lids and hairs on wide area around the eye ................................................................3
Iris lesions
- normal ...................................................................................................................................................................................0
- markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperemia, or injection,
any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) .....................1
- no reaction to light, haemorrhage, gross destruction (any or all of these)................................................................2
Corneal lesions
Degree of opacity (area most dense taken for reading)
- no ulceration or opacity ......................................................................................................................................................0
- scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible ..1
- easily discernible translucent area, details of iris slightly obscured ...........................................................................2
- nacreous areas, no details of iris visible, size of pupil barely discernible ..................................................................3
- opaque cornea, iris not discernible through the opacity ..............................................................................................4
Area of opacity
- one quarter (or less) but not zero .....................................................................................................................................1
- greater than one quarter but less than a half ..................................................................................................................2
- greater than one half but less than three quarters .........................................................................................................3
- greater than three quarters up to whole area ..................................................................................................................4
TOOL USED TO ASSESS SCORE: fluorescein (batch number 2388)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- - After 1 hour, moderate chemosis (scores of 1 or 2), slight redness of the conjunctivae (score of 1) were observed in all 3 animals.
- After 24 hours, a slight chemosis was observed for 1 animal
- After 48 and 72 hours, no ocular reactions were observed. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
1/1/1 |
2/2/1 |
24 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/1/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0.3/0 |
Reversibility*) |
Not applicable |
Not applicable |
0 |
c |
Average time (unit) for reversion |
Not applicable |
Not applicable |
24 hours |
48 hours |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, Anisole is considered as not irritating to eyes and is therefore not classified as eye irritant according to the
EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC). - Executive summary:
In an eye irritation study performed according to the OECD No. 405 guideline and in compliance with the GLP, 0.1 mL of undiluted Anisole was instilled into the conjunctival sac of the left eye of 3 male New Zealand White rabbits. The eyes were not rinsed after administration of the test substance. Ocular reactions were observed approximately 1, 24, 48 and 72 hours after the administration.
The mean individual score were calculated within 3 scoring times (24, 48 and 72 hours).
Moderate then slight reactions of the conjunctiva were observed after 1 hour and 24 hours, respectively. No iris irritation, no opacity of the cornea were observed (the mean individual scores were 0.0 for all tested animals). The mean individual scores were 0.0/0.3/0.0 for chemosis, however; no ocular reactions were observed 48 and 72 hours after instillation of the test substance.
Under the test conditions of this study, Anisole is considered as non-irritant when administered by ocular route in rabbits. Based on these results, no classification is required according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).
This eye irritation study is classified as acceptable. It satisfies the guideline requirement for an eye irritation study in the rabbits.
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