Vinasses, residue of fermentation containing biomass of Corynebacterium glutamicum

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

26 Mar - 09 Apr 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

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

EC Number:

932-215-9

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).

IUPAC Name:

Vinasses, residue of fermentation

Details on test material:

- Name of test material (as cited in study report): ZEN-VEVOMIX
- Physical state / appearance: brown liquid
- Analytical purity: 100%
- Density: 1.31 g/mL (Determined at RCC NOTOX)
- Lot/batch No.: VVM 9109DPC12/100
- Expiration date of the lot/batch: August 1, 1992
- Storage condition of test material: in refrigerator in the dark
- Stability under storage conditions: stable

Test animals

Species:

rat

Strain:

other: Wistar strain, albino, outbred, SPF-quality

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 205-214 g; females: 164-178 g
- Fasting period before study: overnight prior to dosing until approx. 4 hours after administration of the test substance
- Housing: Group housing of 5 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (woody SPF, Broekman Institute, Someren, The Netherlands)
- Diet (ad libitum): standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland)
- Water (ad libitum): tap water; analysis performed quarterly
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSE VOLUME APPLIED: 3.817 mL/kg body weight (dose level (g/kg) / density (1.31 g/mL)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations for mortality / viability: twice daily
- Frequency of observations for clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafter. The time of onset and duration were recorded.
- Frequency of weighing: Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic abnormalities at necropsy

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Signs of ill health or behavioural changes included piloerection, observed in three males and three females approximately 2 hours after dosing.

Gross pathology:

Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.