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EC number: 937-260-8
CAS number: -
Oral: LD50 (rat) > 5000 mg/kg bwDermal: LD50 (rat) > 2000 mg/kg bw
Vinasses, residue of fermentation and
Vinasses, residue of fermentation, depotassified are by-products
obtained after fermentation of molasses, or sugar, or other feedstock,
using different microbial strains, in the production of alcohol, yeast
and other organic substances. Boths are complex UVCB substances,
composed of a mix of inorganic salts and organic molecules of different
type, even macromolecular to some extent. For such a complex UVCB
substance as Vinasses, residue of fermentation and Vinasses, residue of
fermentation, depotassified, it is not possible to state a composition
based on reference substances listed in the EC inventory. Then,
macrocompositions of the two substances, based on dry matter content,
has been established showing that boths substances have the same types
of components with similar ranges. Therefore, an analogy can be done on
toxicological properties between Vinasses, residue of fermentation and
Vinasses, residue of fermentation, depotassified.
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). Since no mortalities occurred in any of the two 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; Lheritier, 1990).
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.
The available data on the acute toxicity of
the analogue are conclusive but not sufficient for classification
according to the DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.
Therefore, using the principle of
read-across, Vinasses, residue of fermentation, depotassified is not
classified according to DSD (67/548/EEC) and CLP (1272/2008/EC)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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