vinasses, residue of fermentation, depotassified

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:

26 Mar - 09 Apr 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

In this study, the substance tested, Vinasses, residue of fermentation, has a chemical composition analogue to Vinasses, residue of fermentation, depotassified and therefore is used in an analogue approach. The analogue approach justification is described in theendpoint study summary. 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

IUPAC Name:

Vinasses, residue of fermentation

Constituent 2

Reference substance name:

932-215-9

EC Number:

932-215-9

IUPAC Name:

932-215-9

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:

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

Body weight:

The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Mean body weight increase within 14 day observation period: males: 74 g, females: 35 g

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU