Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 29 to August 31, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Dec. 2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Lot/batch No.: PPY 31071
- Expiration date of the lot/batch: 1 June 2020
- Stability under test conditions: The test material is stable for at least 24 hours at room temperature and at 4⁰C.
- Storage condition of test material: < -18⁰C

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
- Source: Charles River, Germany
- Fasting period before dosing: Overnight
- Housing: A maximum of 6 animals per sex per cage, transparent macrolon cages
- Weight at time of dosing: between 168-174 g
- Housing: In animal room with control of temperature and humidity
- Diet: Standard diet ad libitum
- Water: Tap water ad libitum
- Acclimatization period: 5 days
- Temperature (°C): 20-24°C
- Humidity : 45-70 %

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:
Undiluted test material 20 mL/kg body weight, corresponding to 1911 mg total Total organic solids (TOS)/kg body weight (limit testing)
No. of animals per sex per dose:
6 (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: within 1 hour and within 4 hours after dosing and at least once daily throughout the observation period. Weighing: just prior to dosing on day 0 and on days 3, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
1 911 mg/kg bw
Based on:
other: Total organic solids
Sex:
female
Dose descriptor:
other: Limit test - no effects were seen
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Mortality:
No mortality.
Clinical signs:
No clinical signs.
Body weight:
Body weights and body weight gains normal.
Gross pathology:
No abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No signs of toxicity were observed among the rats treated with a single oral dose of 1911 mg total organic solids/kg, which was the highest possible dose at dose volume 20 mL/kg, using the undiluted test item.
Executive summary:

The objective of this study was to assess the acute toxicity of Alpha-amylase when administered as a single oral dose to rats followed by an observation period of 14 days. The purpose of the study was to satisfy regulatory demands because the enzyme is used for production of food in EU.

The study was conducted in accordance with the OECD Guideline No 423, “Acute Oral Toxicity – Acute Toxic Class method”. The design of the limit test was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 20 mL/kg body weight corresponding to 1911 mg/kg body weight, based on the Total Organic Solids (TOS) content of the test substance.

This was the highest possible dose level at dose volume 20 mL/kg body weight, using the undiluted test item. No mortality or clinical signs were observed after treatment and the overall body weight gain during the study was considered to be normal. The necropsy revealed no abnormalities.

In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 1911 mg TOS/kg body weight, which was the highest possible dose at dose volume 20 mL/kg, using the undiluted test item.