Mannanase, endo-1,4-β-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 21, 1991 to August 29, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Mannanase, endo-1,4-β-

EC Number:

253-446-5

EC Name:

Mannanase, endo-1,4-β-

Cas Number:

37288-54-3

Molecular formula:

Not available. See Remarks.

IUPAC Name:

mannan endo-1,4-beta-mannosidase IUBMB 3.2.1.78

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:

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

Constituent 4

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

Test material form:

solid: particulate/powder

Details on test material:

- Lot/batch No.: 91-001

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charles River U.K. Limited, Margate, Kent, England.
- Fasting period before dosing: Overnight prior to and approximately 4 hours after dosing.
- Housing: Five animals per cage, metal cages with wire mesh floors.
- Weight at time of dosing: Between 114-134 grams
- Housing: In animal room with control of temperature and humidity
- Diet: Standard diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: 8 days
- Temperature (°C): 20-22°C
- Humidity: 68% (mean daily relative humidity value)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water

Details on oral exposure:

Diluted at a concentration of 50% w/v in distilled water.

Doses:

3.32 g total protein/kg bogyweight, 10 mL/kg bodyweight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days after dosing
- Frequency of observations and weighing: soon after dosing, every 5 hours for the remainder of the day of dosing, twice a day for the rest of the study period. Weighing on Day of dosing (Day 1), Day 8, and Day 15.
- Necropsy of survivors performed: yes (macroscopic post mortem examination)

Statistics:

No

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3.32 other: g/kg bw

Based on:

other: Total protein

Mortality:

Male: 5 g/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5 g/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Pilo-erection was observed in all rats within two minutes after dosing and throughout the remainder of Day 1 (day of dosing). No clinical signs were observed by Day 2.

Gross pathology:

Effects on organs:
No treatment related findings were observed. Histopathology was not performed.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

In conclusion, the acute oral lethal dosage (LD50) to rats of the present Mannanase enzyme, Mannase EM, was greater than 3.32 g total protein/kg bw.

Executive summary:

The study was performed according to GLP and the procedures were according to EEC Methods for the determination of toxicity, Directive 84/449/EEC (OJ No. L251, 19.09.84), Part B, Method B.1. Acute Toxicity (oral).

The test item was supplied as a beige powder and was prepared at a concentration of 50% w/v in distilled water. The dose volume administered was 10 mL/kg.

The only clinical sign observed was piloerect coat in all rats within two minutes after dosing and throughout the remainder of Day 1 (day of dosing). No clinical signs were observed by Day 2. The overall body weight gain during the study was considered to be normal. The post-mortem inspection revealed no abnormalities.

In conclusion, the acute lethal oral dose to rats of the present mannanase enzyme, Mannase EM, was found to be greater than 3.32 g total protein/kg bw.