Cellulase

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 20, 1994 to October 12, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to GLP and the procedures were according to the OECD test guideline 401 (1987).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Annex to Commission Directive 92/69/EEC of 31 July 1992. B1. L 383 A/110. OECD Guidelines for Testing of Chemicals, 401, 1987.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Active enzyme protein of Cellulase (EC no. 232-734-4, CAS no. 9012-54-8, EC name: Cellulase, Enzyme Class no. 3.2.1.4)

Molecular formula:

Not applicable, see remarks.

IUPAC Name:

Active enzyme protein of Cellulase (EC no. 232-734-4, CAS no. 9012-54-8, EC name: Cellulase, Enzyme Class no. 3.2.1.4)

Constituent 2

Reference substance name:

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

Molecular formula:

Not available. See remarks.

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

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.

Constituent 5

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

Test material form:

liquid

Details on test material:

- Lot/batch No.: PPC4795
- Expiration date of the lot/batch: June 2004

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Møllegaard Breeding Center, Ejby, Denmark.
- Fasting period before dosing: approximately 21 hrs overnight
- Housing: Five animals per cage, transparent polycarbonate cages Type IV, 590 MAK dimensions 59 x 38 x 20 cm
- Weight at time of dosing: between 112-121 g (males), 108- 127 g (females)
- Housing: In animal room with control of temperature and humidity
- Diet: Standard diet ad libitum
- Water: Acidified tap water ad libitum
- Acclimation period: 5 days
- Temperature (°C): 19-21°C
- Humidity : 33-80 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

Test batch used as is. Control animals were dosed with tap water.

Details on oral exposure:

Undiluted test material, dose volume 20 mL/kg bw, corresponds to 2.96 g enzyme concentrate dry matter/kg body weight (limit test), based on the conservative assumption that the specific gravity of the undiluted test batch is 1 g/mL.

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: Observations for clinical signs of effect: Frequently during day 1 (dosing day) and then once a day. Weighing on Days 1, 8 and 15
- Animals were fasted from the evening before dosing and until 4 hrs after dosing
- Necropsy of survivors performed: yes

Statistics:

No

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 960 mg/kg bw

Based on:

other: enzyme concentrate dry matter

Mortality:

Male: 2960 mg enzyme concentrate dry matter/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2960 mg enzyme concentrate dry matter/kg bw; Number of animals: 5; Number of deaths: 0
No control animals died during the study.

Clinical signs:

other: Signs of toxicity related to dose levels: No clinical signs were observed in the dose group or in the control group.

Gross pathology:

Effects on organs:
No treatment related findings were observed in the dose group or the control group. Histopathology was not performed.

Applicant's summary and conclusion

Interpretation of results:

other: Data insufficient for classification as 2960 mg enzyme concentrate dry matter/kg bw corresponds to 1512 mg active enzyme protein matter/kg bw

Conclusions:

In conclusion, the acute oral lethal dosage (LD50) of cellulase was greater than 2960 mg enzyme concentrate dry matter/kg bw.

Executive summary:

The study was conducted in accordance with the OECD Guideline No 401, “Acute Oral Toxicity”. The limit test procedure was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 20 mL/kg of the undiluted test material.

Five male and five female Wistar rats were dosed a volume of 20 mL/kg bw corrosponding to 2960 mg enzyme concentrate dry matter/kg bw. A control group was dosed with tap water at the same dose volume. 

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 2960 mg enzyme concentrate dry matter/kg bw.