Oxidase, glucose

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

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

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:

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

Molecular formula:

Not available.

IUPAC Name:

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

Constituent 5

Reference substance name:

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

Molecular formula:

Not available.

IUPAC Name:

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

Test material form:

solid: particulate/powder

Details on test material:

- Product: Glucose oxydase from Aspergillus niger
- Reference: 1040

Test animals

Species:

rat

Strain:

Wistar

Remarks:

SPF (Specific Pathogen Free)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA CREDO - BP 0109 - 69592 L'Arbesle Cedex France
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: >6 weeks
- Weight at study initiation: mean of 154.4 (control) and 157.0 (test) for male; 138.2 (control) and 139.6 (test) for female
- Fasting period before study: yes; additionally food was withheld for a period of approximately 3-4 hours after administration
- Housing: Individually housed in cage of standard size, on dust-free white wood shavings as bedding
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 45-65%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE: Distilled water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

DOSAGE PREPARATION (if unusual): 10 g of the test substance was weighed followed by addition of distilled water in a sufficient amount in order to obtain a 20 mL preparation. A brown solution was obtained.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed on the day of randomization and days 1, 3, 7, and 14; animals were regularly monitored on the day of administration and then examined clinically at least once a day for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: liver, spleen, kidneys, stomach, lungs, and heart were examined macroscopically

Statistics:

None

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

11 419.9 other: mg enzyme concentrate dry matter/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 419.9 other: mg active enzyme protein/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study.

Clinical signs:

other: No clinical signs of toxicity were observed during the study.

Gross pathology:

No macroscopic abnormality of tissues or organs was noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, the LD50 of the test substance is greater than 5000 mg/kg of body weight in male and female Wistar rats. This is equivalent to of 11419.9 mg enzyme concentrate dry matter/kg bw (equivalent to 1419.9 mg active enzyme protein/kg bw). 

Executive summary:

The acute oral toxicity of the test substance was studied in rats in a study using methods equivalent to OECD guideline 420. 5000 mg/kg of the test substance as a solution in distilled water was administered orally in a volume of 10 mL/kg. A group of control animals dosed under the same conditions as the animals treated with 10 mL/kg of distilled water served as a reference. Animals were monitored daily for 14 days after administration. Animals were weighed on the day of randomization (D-1) and test days 1, 3, 7, and 14.

 

No mortality or clinical signs were observed during the study. Mean body weight change of treated animals was not significantly different from that of controls. No macroscopic abnormality of tissues or organs was noted at necropsy of animals sacrificed after a 14-day observation period. Therefore, under the experimental conditions, oral administration of the test substance at the dose of 5000 mg/kg did not cause any mortality in male and female Wistar rats. This is equivalent to of 11419.9 mg enzyme concentrate dry matter/kg bw (equivalent to 1419.9 mg active enzyme protein/kg bw).