Saccharomyces cerevisiae, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August - October 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed in compliance with test guidelines in compliance with GLP, performed on Gistex which has a comparable composition on salt free dry matter

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Gistex

IUPAC Name:

Gistex

Details on test material:

Cream coloured powder
Batch FM 8850-03
protein content: 68.9%
carbohydrates: 5.1%
ash content: 12.1%
Lipids: 0.51%

Test animals

Species:

mouse

Strain:

other: Swiss outbred (Crl:CD1)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, F.R. Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: Males: 32-35 g; Females: 24-28 g
- Fasting period before study: not applicable
- Housing: Makrolon cages with a bedding of dustfree woodshavings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity(%): 40-70%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: August 22,1989 To: September 22, 1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 ml/kg bodyweight
- Justification for choice of vehicle: not provided
- Lot/batch no. (if required): FM 8850-03
- Purity: not provided
MAXIMUM DOSE VOLUME APPLIED: 0.35 ml
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: recommended for limit test

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently observed for signs of intoxication during the first 4 post-treatment hours, and at least once daily, thereafter. Individual body weights were recorded on day 0, 3, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: none

Statistics:

not performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occured

Clinical signs:

other: signs of intoxication were not observed after treatment

Gross pathology:

No treatment-related gross alterations were seen

Other findings:

- Organ weights: not determined
- Histopathology: not performed
- Potential target organs: not identified
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance Gistex is not harmful if swallowed, under the conditions of this study and according to the EEC standards (EEC directive 83/467/EEC published in the Official Journal of European Communities, L257, volume 26, 16 September 1983)