Filter cake from enzyme fermentation, consisting of fungal biomass and inorganic filtration aid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

23 Jul - 06 Aug 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study, time schedule is missing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

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:

Vinasses, residue of fermentation

IUPAC Name:

Vinasses, residue of fermentation

Details on test material:

- Name of test material (as cited in study report): LUCULLUS 235/02
- Appearance/ physical state: brown paste, viscous product
- Analytical purity: 100%
- Lot/batch No.: Lot 235/04
- Stability under test conditions (preparation in the vehicle): 8 hours; when diluted risk of microbial development
- Storage condition of test material: at 4°C

Test animals

Species:

rat

Strain:

other: Sprague-Dawley ICO: OFA-SD (IOPS Caw)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: approximately 6 weeks old
- Weight at study initiation: mean body weight of 182 +/- 7 g for males and 162 +/- 6 g for females
- Fasting period before study: approximately 18 hours
- Housing: in groups of 5 animals of the same sex during the study; they were housed in polycarbonate cages (48 x 27 x 20 cm) covered with a stainless steel lid containing food and a water bottle
- Diet (ad libitum): certified pelleted diet (rats - mice sustenance ref. A04 C - U.A.R. 91360 Villemoisson-sur-Orge, France)
- Water (ad libitum): free access to tap water filtered through a 0.22 micron filter membrane
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no. (if required): batch No. 1355
- Purity: water for injections

Doses:

5000 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 : Frequently on the day of administration and at least once a day during the 14-day observation period
- Frequency of weighing: The animals were weighed individually just before administration of the test substance and then on days 5, 8 and 15
- Necropsy of survivors performed: yes; after opening the thoracic and abdominal cavities, a macroscopic examination of the main organs was performed: digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities. Due to the absence of macroscopic lesions, no organ samples were taken and no histiological examination was performed.
- Other examinations performed: clinical signs and body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the observation time

Clinical signs:

other: No clinical signs were observed during the study.

Gross pathology:

A macroscopic examination of the main organs of the animals sacrified at the end of the study revealed no apparent abnormalities.