Glucanase, β-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cellulase

EC Number:

232-734-4

EC Name:

Cellulase

Cas Number:

9012-54-8

IUPAC Name:

1,4-(1,3;1,4)-beta-D-Glucan-4-glucanohydrolase

Constituent 2

Reference substance name:

Glucanase, β-

EC Number:

232-979-7

EC Name:

Glucanase, β-

Cas Number:

9074-98-0

Molecular formula:

not available (see remarks)

IUPAC Name:

endo-1,4-ß-glucanase IUBMB EC 3.2.1.4

Constituent 3

Reference substance name:

Hemicellulase

EC Number:

232-799-9

EC Name:

Hemicellulase

Cas Number:

9025-56-3

IUPAC Name:

Hemicellulase

Specific details on test material used for the study:

- Name used in the study report: Cellulase 2000 L
- enzyme complex of cellulase, beta-glucanase and hemicellulase
- batch number WE 540
- 2042 U/g solution
- 35557 U/g total organic solids

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

2000 mg/kg bw/d

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

A limit dose of 2000 mg/kg was given to a group of 5 male and 5 female Sprague Dawley rats. All animals were observed for mortality, morbidity and signs of toxicity over a period of 14 days. All animals were killed on day 15 and a necropsy performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred throughout the entire investigation period.

Clinical signs:

other: No overt signs of toxicity were noted throughout the entire investigation period.

Gross pathology:

No abnormalities were recorded at the macroscopic examination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met