Oxidase, glucose

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Active enzyme protein of Glucose oxidase (EC no. 232-601-0, CAS no. 9001-37-0, EC name: Glucose oxidase, Enzyme Class no. 1.1.3.4)

Molecular formula:

Not applicable, see remarks.

IUPAC Name:

Active enzyme protein of Glucose oxidase (EC no. 232-601-0, CAS no. 9001-37-0, EC name: Glucose oxidase, Enzyme Class no. 1.1.3.4)

Constituent 2

Reference substance name:

Protein as a constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available. See remarks.

IUPAC Name:

Protein as a constituent of enzyme deriving from the fermentation or extraction process

Constituent 3

Reference substance name:

Carbohydrates constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available. See remarks.

IUPAC Name:

Carbohydrates constituent of enzyme deriving from the fermentation or extraction process

Constituent 4

Reference substance name:

Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available. See remarks.

IUPAC Name:

Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process

Constituent 5

Reference substance name:

Lipids as a constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available. See remarks.

IUPAC Name:

Lipids as a constituent of enzyme deriving from the fermentation or extraction process

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: ALL

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: ALL

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

animal: ALL

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 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 which is equivalen to 1.36 mg active enzyme protein/ kg bw or 7.04 enzyme concentrate dry matter/kg bw.. 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