Registration Dossier

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:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
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 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
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:
No clinical signs of toxicity were observed during the study.
Body weight:
Mean body weight change of treated animals was not significantly different from that of control animals.
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.
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.