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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

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 4-bromobenzoate
EC Number:
210-596-6
EC Name:
Methyl 4-bromobenzoate
Cas Number:
619-42-1
Molecular formula:
C8H7BrO2
IUPAC Name:
methyl 4-bromobenzoate
Test material form:
solid: crystalline
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 051101-Sa
- Expiration date of the lot/batch: 2002-11-1
- Purity test date: 2001-11-12



STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: Hydrolysis is possible


Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, D-97633
- Weight at study initiation: 2,5; 1,8; 1,8 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height, with a wooden rest shelf, 15 cm x 59 cm
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum. Random samples of the feed are analysed for contaminants by Altromin, D- 32791 Lage. Hay-briquettes were offered additionally as a dietary supplement.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.8
- Humidity (%): 54.5
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: Experimental starting date 26 Nevember 2001; Experimental completion date 18 January 2002

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 73, 73 and 75 mg


Duration of treatment / exposure:
The substance was instilled into the conjuctival sac of one eye of each of 3 rabbits
Observation period (in vivo):
An observation of the animals was done immediatetly after the application and 1, 24, 48 and 72 hours after apllication of the test substance.
Number of animals or in vitro replicates:
3 female New Zealand rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vitro

Other effects / acceptance of results:
Table1: Scores of the test eyes

Examination of corneae and irises. Individual data and means. For the scoring scheme used, see Table 2

Time after instillation Corneae
Animal No. Irises
61 62 63 61 62 63
1h 0 0 0 0 0 0
24h 0 0 0 0 0 0
48h 0 0 0 0 0 0
72h 0 0 0 0 0 0
Mean (24-72h) 0.0 0.0 0.0 0.0 0.0 0.0


Table 1 cont.: Scores of the test eyes.

Examination of conjunctivae. Individual data and means. For the scoring scheme used, see Table 2.
Time after instillation Redness
Animal No. Chemosis
Animal No.
1h 61 62 63 61 62 63
24h 1 0 1 0 0 0
48h 0 0 0 0 0 0
72h 0 0 0 0 0 0
Mean (24-72h) 0.0 0.0 0.0 0.0 0.0 0.0


Table 2: Scoring scheme for eye lesion.

CORNEA

Opacity: degree of density (area most dense ist taken for reading).
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity details of iris clearly visible

IRIS

0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection; any of these or combination of any thereof, iris still reacting to light

Chemosis: lids and/or nictating membranes

0 No swelling
1 Any swelling above normal

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: all animals
Time point:
other: 1h; 24h; 48h; 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: 1h; 24h; 48h; 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
other: animal 1 and 3
Time point:
other: 1h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
other: all animals
Time point:
other: 1h; 24h; 48h; 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

This acute eye irritation study is considered to be reliable. It does satisfy the guideline requirement for an acute eye irritation study OECD 405 with rabbit