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EC number: 932-165-8
CAS number: -
Oral: LD50 (rat) > 5000 mg/kg bwDermal: LD50 (rat) > 2000 mg/kg bw
Within the Vinasses
category, data on acute toxicity are only available for one subgroup of Vinasses,
e. g. Vinasses, residue of fermentation. However, all Vinasses subgroups
share a common origin and are therefore constituted of the same
components determining their toxicological properties. Thus, read-across
is performed based on a category approach (a detailed justification is
attached in IUCLID section 13).
toxicity of Vinasses, residue of fermentation after oral administration
to Wistar rats was investigated in a limit test according to OECD
guideline 401 under GLP conditions (Daamen, 1992). A group of 10 Wistar
rats (5 per sex) were given the undiluted test material by gavage at
5000 mg/kg bw (3.817 mL/kg bw) and observed for a period of 14 days
post-administration. The dose level was selected based on the results of
a pilot study with pairs of male and female animals given the test
material at 1000, 2000 and 5000 mg/bw, in which no abnormalities had
been noted during the 7-day observation period.
occurred during the study period. Signs of ill health or behavioural
changes included piloerection, observed in 3 males and 3 females
approximately 2 h after dosing. 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.
Macroscopic post-mortem examination of the surviving animals at
termination did not reveal any abnormalities. Therefore, the oral LD50
for male and female rats was considered to be greater than 5000 mg/kg bw.
reliable studies are available, in which the acute oral toxicity of Vinasses,
residue of fermentation was studied in rats administered the test
material by gavage at 5000 mg/kg bw (Clouzeau, 1992; Lheritier, 1990;
van Eeken and Aboulwafa-van Velthoven, 1983). Since no mortalities
occurred in any of the three studies. the oral LD50 for male and female
rats was determined to be greater than 5000 mg/kg bw. Moreover, no
clinical signs and no abnormalities in body weight (gain) were observed
during the 14-day observation period and macroscopic examinations at
termination revealed no treatment-related changes (Clouzeau, 1992;
In an earlier study, the oral LD50 was
reported to be greater than 40000 mg/kg bw in rats administered three
different types of Vinasses, residue of fermentation (van Eeken, 1974).
is not available.
The acute dermal
toxicity of Vinasses, residue of fermentation was tested in accordance
with OECD guideline 402 and in compliance with GLP (van Otterdijk,
2010a). The study was performed as a limit test in two groups of Wistar
rats (5 males and 5 females) at a dose of 2000 mg/kg bw (1.05 mL/kg bw).
The test substance was applied unchanged on the shaved skin of the test
animals for 24 h under occlusive conditions. The test animals were
observed for 14 days after application, and sacrificed thereafter for
gross pathological examinations. No mortalities occurred. Slight
clinical signs were observed in 9/10 animals on days 1 and/or 2 and
included lethargy, hunched posture, shallow respiration, piloerection,
ptosis and/or chromodacryorrhoea. No abnormal changes in body weight
(gain) were observed. No abnormalities were found at macroscopic post
mortem examination of the animals. According to the results of this
study, the dermal LD50 value for male and female rats was greater than
2000 mg/kg bw.
An acute toxicity study was conducted
in rats administered Vinasses, residue of fermentation by intravenous
injection (Prinsen, 1994). The 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.
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.
At 4 h after dosing 500 mg/kg bw,
sluggishness was observed in all females, while a swollen nose was
observed at 1 and 4 hours after dosing. At 750 mg/kg bw, immediately
after dosing and until 4 h thereafter, sluggishness was observed in all
males and females. A swollen nose was observed in males at 1 h after
dosing and in females at 1-4 h after dosing. In addition, the males
showed swollen legs at 1-4 h after dosing and females piloerection at 1
or 4 h after dosing. Two males and one female showed dyspnoea and coma.
At 1000 mg/kg bw, two males showed dyspnoea and coma immediately after
dosing. Immediately after dosing and until 4 h thereafter, sluggishness,
swollen legs and nose were observed in all males (except one). In
addition, the males showed a blue discolouration at 1 h after dosing.
One male showed vocalization at 4 h after dosing. In females,
sluggishness (at 1 h after dosing), swollen nose (at 1-4 h after dosing)
and piloerection (at 4 h after dosing) were observed. One female showed
endogenous blue discolouration. Four females showed dyspnoea and coma
immediately after dosing (and needed reanimation to survive). During the
remainder of the 14-day observation period, no clinical symptoms were
observed at any dose.
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. 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.
Based on the study results, the LD50
(i.v.) was determined to be around 1000 mg/kg bw.
In another study, three types of Vinasses,
residue of fermentation, were tested for acute toxicity in rats after
intraperitoneal injection (van Eeken, 1974). Five days after dosing, the
LD50 (i.p.) values were determined to be 7070, 10000 and 11800 mg/kg bw
for each of the tested samples, respectively.
The available data on the acute toxicity of the
substance are conclusive but not sufficient for classification according
to the DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.
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