Fructofuranosidase, β-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 March - 6 April 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

Deviations:

yes

Remarks:

animal number and schedule of administration: 5 animals per sex were used (Limit test) and a preliminary test was conducted using 2 females administered doses of 400 or 800 mg/kg bw/day

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Xylanase, endo-1,4-

EC Number:

232-800-2

EC Name:

Xylanase, endo-1,4-

Cas Number:

9025-57-4

Molecular formula:

Not applicable, see remarks.

IUPAC Name:

endo-1,4-beta-xylanase

Test animals

Species:

rat

Strain:

other: CD strain (remote Sprague-Dawley origin)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK), Margate, England
- Age at study initiation: 5 weeks
- Weight at study initiation: 109 - 136 g (males), 99 - 117 g (females)
- Fasting period before study: overnight
- Housing: 5 animals per sex in stainless steel grid cages (RS Biotech, Northants, England)
- Diet: complete pelleted rodent diet (RM 1 (E) SQC,Special Diets Services Limited, Witham, England), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

purifed (obtained by the reverse osmosis of water)

Details on oral exposure:

VEHICLE
- purified water (obtained by the reverse osmosis of water)
- Concentration in vehicle: the test material was prepared at the appropriate concentration in purified water

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations and inspections for morbidity / mortality were performed two times within the first hours after test substance application and two forther ones at Day 1. From Day 2 onwards animals were inspected twice daily and bodyweights were determined on the the day before dosing and on Day 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: larger organs were sectioned and gastrointestinal tract was opened at intervals for examination of the mucosal surfaces

Results and discussion

Preliminary study:

A preliminary study was carried out using two female rats given an oral administration of [test substance] at a dosages of 400 or 800 mg/kg bw, at a constant volume-dosage of 20 mL/kg bw in purified water. In this study no deaths occurred.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths observed during the study.

Clinical signs:

There were no clinical signs observed.

Body weight:

The animals showed expected gains in body weight over the observation period.

Gross pathology:

No abnormalities were noted at the macroscopic examination at study termination.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was determined. CLP: not classified