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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:
other: The study was conducted according to the relevant official OECD guideline No. 405 and in compliance with GLP. No deviations from the guideline were reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
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

Constituent 1
Chemical structure
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
Details on test material:
- Physical state: liquid
- Stability under test conditions: not reported
- Storage condition of test material: stored at ambient temperature

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:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.