Amylase, gluco-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 30 to October 21, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Dec. 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Active enzyme protein of Amylase, gluco- (EC no. 232-877-2, CAS no. 9032-08-0, EC name: glucan 1,4-alpha-glucosidase, Enzyme Class no. 3.2.1.3)

IUPAC Name:

Active enzyme protein of Amylase, gluco- (EC no. 232-877-2, CAS no. 9032-08-0, EC name: glucan 1,4-alpha-glucosidase, Enzyme Class no. 3.2.1.3)

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:

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

Test material form:

liquid

Details on test material:

Substance type: UVCB
- Physical state: liquid
- Lot/batch No.: trg08050/52
- Expiration date of the lot/batch: At least stable until January 2011
- Stability under test conditions: The test material and dilutions in water (25% and 50%) are stable for
at least 5 hours at room temperature, 7 days at 4 degrees Celcius and 90 days at minus 20 degrees
of Celcius
- Storage condition of test material: minus 20 degrees of Celcius

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

- Source: Taconic Europe, DK-4623 Lille Skensved, Denmark.
- Fasting period before dosing: Overnight
- Housing: Two animals per cage, transparent polycarbonate cages floor area 1500 cm2 – height 21 cm
- Weight at time of dosing: between 147-152 g
- Housing: In animal room with control of temperature and humidity
- Diet: Standard diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: 5 days
- Temperature (°C): 18-24°C
- Humidity : 40-70 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

The liquid test material was dosed undiluted

Details on oral exposure:

Maximum Dose Volumen applied: 10 mL/kg

Doses:

Undiluted test material 10 mL/kg bw, corresponding to 1996.3 mg total protein/kg body weight (limit test).

No. of animals per sex per dose:

5 (only females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for clinical signs of effect: 15 minutes and 1, 3 and 6 hours and daily after dosing. Weighing:at arrival, on Days 1, 2, 3, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

Sighting study: The starting dose level was based on information from the Sponsor. One female animal was treated with 1996.3 mg total protein/kg body weight. As no evident signs of toxicity were observed in this animal, the main study was carried out at this dose level.

Effect levels

Key result

Sex:

female

Dose descriptor:

other: Limit test - no effects were seen

Effect level:

> 1 996.3 mg/kg bw

Based on:

other: total protein

Mortality:

No mortality.

Clinical signs:

other: No clinical signs.

Gross pathology:

No abnormalities.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

No signs of toxicity were observed among the rats treated with a single oral dose of 1996.3 mg/kg based on total protein, which was the highest possible dose at dose volume 10 mL/kg, using the undiluted test item.

Executive summary:

The objective of this study was to assess the acute toxicity of glucoamylase when administered as a single oral dose to rats followed by an observation period of 14 days. A preliminary sighting study using one female animal was included to estimate the dose effect for toxicity and to provide information on dose selection for the main study.

The study was conducted in accordance with the OECD Guideline No 420, “Acute Oral Toxicity – Fixed Dose Procedure”. The limit test was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 10 mL/kg.

The study was initiated with a sighting study at dose level 1996.3 mg/kg based on total protein, using one female animal. This was the highest possible dose level at dose volume 10 mL/kg, using the undiluted test item. On the basis of the results of the sighting study, the main study was performed in four additional female rats given a dose of 1996.3 mg/kg body weight. No clinical signs were observed and the overall body weight gain during the study was considered to be normal. The post-mortem inspection revealed no abnormalities.

In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 1996.3 mg/kg based on total protein, which was the highest possible dose at dose volume 10 mL/kg, using the undiluted test item.