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EC number: 202-259-7 | CAS number: 93-58-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-04-15 to 1985-04-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl benzoate
- EC Number:
- 202-259-7
- EC Name:
- Methyl benzoate
- Cas Number:
- 93-58-3
- Molecular formula:
- C8H8O2
- IUPAC Name:
- methyl benzoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.63 to 3.16 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): standard rabbit diet (A.W. Tindall Limited, Holbeach, Lincolnshire, UK) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: minimum five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL of neat substance
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- up to 21 days, if eye irritation persisted at the 72 hours observation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Test substance was not removed
SCORING SYSTEM:
Assessment of damage/irritation was made according to the numerical evaluation system according to Draize JH, 1959, Association of Food and Drug Officials of USA, Austin, Texas "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".
TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by use of a standard ophtalmoscope (Keeler)
EVALUATION OF DATA: The numerical data obtained from the observations was evaluated according to a modified version of the system described by Kay JH and Calandra JC, J Soc Cosmet Chem 1962, 13, 281-289.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All animals showed some response at the first reading that was performed 1 hour after treatment. Irritation effects were transient and all three tested animals showed only slight irritation effects 24 hours after the treatment that consisted mainly of redness of the conjunctivae (all three animals) and weak chemosis (two out of three animals). All effects had disappeared after 72 hours.
- Other effects:
- No other effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is non-irritating to the rabbit eye.
- Executive summary:
The eye irritation potential of the substance methyl benzoate was studied under GLP conditions in rabbits according to OECD guideline No 405. Three healthy New Zealand White rabbits aged 12 to 16 weeks and weighing 2.6 to 3.2 kg and showing no evidence of ocular lesions were used in the test. An aliquot of 0.1 mL of the neat test material was instilled into the right eye of each rabbit by gently pulling the lower lid away from the eyeball. The eyelids were then held together for about one second. The left eyes remained untreated and served as a control. Damage and irritation of the eyes were assessed after 1, 24, 48 and 72 hours after treatment according to the numerical evaluation scheme developed by Draize. The observation made at 24 hours after treatment revealed no effects in the cornea or iris of all three animals. Redness of the conjunctivae was observed in all three animals and chemosis was seen in 2 out of three animals. All effects were transient and had disappeared at the observation made 72 hours after treatment. The scores for conjunctival redness and chemosis (mean of gradings at 24, 48 and 72 hours) were not exceeding 0.66. The substance hence is considered as non-irritating to the rabbit eye.
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