Oxidase, glucose

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive Annex I, II, III, and IV, Official Journal of the European Communities published in L 110 A, volume 36, 4 May 1993 § 3.2.6. I and § 3.2.5

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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 - 3.6 kg
- Housing: The animals were kept in a PPO-plast cage (Noryl®, floor area: 2576 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/hr
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

Initial Test: 3 minutes, 1 hour, 4 hours
Confirmatory Tests: 4 hours

Observation period:

72 hours

Number of animals:

Initial Test: 1 female
Confirmatory Test: 2 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Each gauze patch was secured with adhesive tape and thereafter the circumferential area of the patches was fixed with Scanpore tape. Nobafix gauze was wrapped around the trunk to secure the dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water and mild soap

OBSERVATION TIME POINTS
- 1, 24, 48, and 72 hours

SCORING SYSTEM:
- Method of calculation: The scores for erythema and oedema for the 3 readings at 24, 48, and 72 hours were obtained and divided by 3. The results are the average scores for erythema and oedema formation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: ALL

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

edema score

Basis:

animal: ALL

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Initial Test: No reactions were observed at the 3-minute and 1-hour test substance application. Very slight erythema and oedema was observed in the 4-hour test site application for the 1-hour observation period and very slight erythema was observed at the same test site at the 24-hour observation period.

Confirmatory Test: Not reactions were observed at any test site or negative control site at any of the time points.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean score for erythema was 0.1 and the mean score for oedema was 0.0. The test substance is a non-irritant.

Executive summary:

The acute dermal irritant effect of the test substance was carried out according to OECD Guideline 404. The initial study was carried out with one rabbit. The study was completed with two additional rabbits. 0.5 mL of the test substance was applied which is equivalen to 6.78 mg active enzyme protein/ kg bw or 35.2 enzyme concentrate dry matter/kg bw. 

In the initial test, no skin reactions were observed in the 3-minute and 1-hour exposure time applications. Very slight erythema was observed in the 4-hour exposure time application at 1 and 24 hours after exposure. Very slight oedema was observed in the 4-hour exposure time application at 1 hour after exposure in the same test site. No other reactions were observed 1, 24, 48, and 72 hours after patch removal. No skin reactions were observed in any of the additional rabbits at any of the observation periods. No clinical signs were observed in the animals during daily observations. The mean score for erythema was 0.1 and the mean score for oedema was 0.0.