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Toxicological information

Eye irritation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Substance type: UVCB
- Name of test material (as cited in study report): Glucose Oxidase
- Lot/batch No.: R-GOx-04004
- Physical state: Clear brown liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kisslegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.1 - 3.8 kg
- Housing: The animals were kept individually in PPO-plast cages (Noryl®, floor area: 3969 cm2) with perforated floor. The tray under the cage was cleaned 2 times a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
Animals were observed for 72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE: No

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: ALL
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: ALL
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: ALL
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: ALL
Time point:
24/48/72 h
Score:
0
Max. score:
3
Other effects:
In all 3 animals, slight signs of conjunctival irritation (chemosis, redness and discharge) were observed at the 1-hour observation. No further reactions were observed among the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Only slight signs of irritation were observed at 1 hour. All eyes were normal by 24 hours.
Executive summary:

The eye irritant effect of the test substance was investigated according to the method OECD Guideline 405. One rabbit was exposed to 0.1 mL of the test substance in the left eye. The eye was examined 1, 24, 48, and 72 hours after exposure. A well-defined response was not observed in the original animal and the study was carried out on two additional animals. Only slight signs of irritation were observed in the first hour after exposure.

The following mean values, based on results from the 24, 48, and 72 hour readings, were calculated:

Cornea Iris Lesion Oedema of conjunctiva Redness of conjunctiva
0 0 0 0