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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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

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.

Applicant's summary and conclusion

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