Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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: Study conducted according to GLP and OECD Guideline. For justification of read across see section 13.

Data source

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

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
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Methyl benzoate
EC Number:
202-259-7
EC Name:
Methyl benzoate
Cas Number:
93-58-3
IUPAC Name:
methyl benzoate

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
- Age at study initiation: app roximately 12 to 16 weeks
- Weight at study initiation: weight range 2.63 - 3.16 kg
- Housing: indicidually
- Diet: standard laboratory diet (Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 2 °C
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:
Single treatment, eyelids were held together for about 1 second
Observation period (in vivo):
7 days, assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
according to Draize J.H., 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: standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h / 48 h 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h / 48 h 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 h / 48 h 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h / 48 h 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 h / 48 h 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 h / 48 h 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h / 48 h 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h / 48 h 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h / 48 h 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h / 48 h 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h / 48 h 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 h / 48 h 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A test was conducted on methyl benzoate to assess its eye irritating potential to rabbits' eyes. Three rabbits were used. As a result, the substance was considered to be non irritating to eyes.
Executive summary:

A test was conducted on methyl benzoate to assess its eye irritating potential to rabbits' eyes. Three New Zealand White rabbits were used. The study was performed in accordance to GLP and OECD Guideline 405. After a single application of 0.1 mL methyl benzoate, the animals were observed for a period of 7 days and eye reactions were recorded at 1, 24, 48 and 71 hours. The mean scores for cornea opacity calculated for the time points 24, 48 and 72 hours were 0, 0, 0 for animal1, 2 and 3, respectively. Iris mean scores were 0, 0, 0 as well. The conjunctiva scores were calculated to be 0.67, 0.67, 0.67 and chemosis scores were 0.67, 0.67 and 0. All findings were reversible within 72 hours. On the basis of these results, the substance is considered to be non irritating to the rabbits' eyes.