Vinasses, residue of fermentation, salt-enriched

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

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

Adequacy of study:

other information

Study period:

08 Feb - 24 Feb 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD No. 401, EEC Directive 92/69/EEC, Annex, Part B (B.1)

Deviations:

yes

Remarks:

i.v. ; This study was carried out with three dose levels (500, 750 and 1000 mg/kg bw, using five female albino rats for each dose level and five males for the two high dose levels (i.v.))

GLP compliance:

yes

Limit test:

no

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): Prouvital, code GBR 50009
- Physical state / appearance: dark-brown, viscous liquid (described by sponsor as black liquid)
- Analytical purity: 100%
- Lot/batch No.: 93/204
- Storage condition of test material: in the dark at room temperature

Test animals

Species:

rat

Strain:

other: Wistar outbred rats Crl: WI (WU) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 8 weeks old
- Housing: 5 animals/cage (stainless steel cages, 45x32x18 cm, fitted with wire screen floor and front)
- Diet (e.g. ad libitum): standard laboratory rat diet
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 42.5 - 72.5
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:

intravenous

Vehicle:

other: demineralized water

Details on exposure:

The exact volume of the test dilution to be dosed was calculated for each animal individually and applied by syringe, equipped with a needle suitable for intravenous injection.
(viz. 2.5, 3.75 and 5 mL/kg body weight)

Doses:

500, 750 and 1000 mg/kg bw
(preliminary test: 2000, 1000, 750, 500, 250 mg/kg bw)

No. of animals per sex per dose:

5 (males without the low dose level group)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (observations were made within 1 hour and within 4 hours after dosing, and subsequently at least once daily throughout an observation period of 14 days)
- Frequency of observations and weighing: immediately before dosing and on day 3, 7 and 14 of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological changes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: intravenous; some animals were reanimated

Mortality:

Two males and one female showed dyspnoea and coma, immediately after dosing (750 mg/kg bw) and needed reanimation to survive.
Immediately after dosing (1000 mg/kg bw) two males showed dyspnoea and coma and needed reanimation. Within ten minutes after dosing , despite reanimation, one male died. At the same doses of 1000 mg/kg bw four females showed dyspnoea and coma, immediately after dosing and needed reanimation to survive.

Clinical signs:

500 mg/kg bw: At 4 hours after dosing, sluggishness was observed in all females, while a swollen nose was observed at 1 and 4 hours after dosing.
750 mg/kg bw: Immediately after dosing until 4 hours after dosing, sluggishness was observed in all males and females. A swollen nose was observed in males at 1 hour after dosing and in females at 1-4 hours after dosing. In addition, the males showed swollen legs at 1-4 hours after dosing and females piloerection at 1 hour after dosing or at 4 hours after dosing. Two males and one female showed dyspnoea and coma.

1000 mg/kg bw: Two males showed dyspnoea and coma immediately after dosing. Immediately after dosing until 4 hours after dosing, sluggishness, swollen legs and nose were observed in all males (except one). In addition, the males showed a blue discolouration at 1 hour after dosing. One male showed vocalization at 4 hours after dosing. In females, sluggishness (at 1 hour after dosing), swollen nose (at 1-4 hours after dosing) and piloerection (at 4 hour after dosing) were observed. One female showed endogenous blue discolouration. Four females showed dyspnoea and coma immediately after dosing (and needed reanimation to survive).

all doses: During the remainder of 14-day observation period, no clinical symptoms were observed.

Body weight:

generally, all surviving animals gained weight during the 14-day observation period
one male and one female both treated with the 750 mg/kg bw dose level showed a very minor dip in body weight

Gross pathology:

Macroscopic examination of the animals did not reveal any treatment-related gross alterations at the end of the observation period. The one male that died also did not reveal treatment-related gross alterations.

Any other information on results incl. tables

Table 1: Summary of clinical symptoms and incidences

Observation	500 mg/kg bw	750 mg/kg bw		1000 mg/kg bw
	Female	Male	Female	Male	Female
Sluggishness	5/5	5/5	5/5	5/5	5/5
Swollen nose	5/5	5/5	5/5	4/5	5/5
Swollen legs	-	5/5	-	4/5	-
Piloerection	-	-	5/5		5/5
Blue discolouration	-	-	-	4/5	1/5
Vocalization	-	-	-	1/5	-
Dyspnoea	-	2/5	1/5	2/5	4/5
Coma	-	2/5	1/5	2/5	4/5
Reanimation	-	2/5	1/5	2/5	4/5
Death	-	-	-	1/5	-