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EC number: 937-260-8
CAS number: -
Vinasses, residue of fermentation
(Vinasses) 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.
Vinasses category, animal and human data on the sensitisation potential
of Vinasses are available for three subgroups of Vinasses, e. g.
Vinasses, residue of fermentation, Vinasses, residue of fermentation,
salt-enriched and Vinasses, residue of fermentation containing biomass
of bakers yeast (Saccharomyces cerevisiae). However, all Vinasses
subgroups share a common origin and are therefore constituted of the
same components determining their toxicological properties. Therefore,
an analogy can be done on toxicological properties between subgroups of
Vinasses and Vinasses, residue of fermentation, depotassified.
first Local Lymph Node Assay was performed with Vinasses, residue of
fermentation in CBA/J mice according to OECD 429 (van Otterdijk, 2010c).
Three experimental groups of five female/J mice were treated with test
substance concentrations of 25, 50 or 100% w/w on three consecutive
days, by open application on the ears. Five vehicle control animals were
similarly treated, but with vehicle alone (propylene glycol). The author
stated that no irritation of the ears was observed in the presence of
brown remnants of the test substance on the ears. However, in all
animals treated with the test substance concentration of 100%, increased
sizes of the auricular lymph nodes were observed. The ear thickness was
not measured. The SI values calculated for the substance concentrations
25, 50 and 100% were 1.6, 1.9 and 9.3, respectively.
In a repeat
experiment, the identical test substance in concentrations of 25, 50 and
100% caused a slight but noticeable increase in mean ear puncture
weights at 100% and yielded SI values of 1.5, 2.1 and 4.0, respectively
addition, a second representative sample of Vinasses, residue of
fermentation was tested using the same experimental conditions as
already described above with the exception that ear punctures were
performed (Beerens-Heijnen, 2011b). In this experiment, test substance
concentrations of 25, 50 and 100% resulted in SI values of 2.0, 2.8 and
2.9, respectively, without affecting ear puncture weights.
a Local Lymph Node Assay according to OECD 429 including measurements of
ear puncture weight was also performed with the test substance Vinasses,
residue of fermentation containing biomass of bakers yeast (Saccharomyces
cerevisiae) (Beerens-Heijnen, 2011c). Ear skins of 5 female CBA mice
were treated with 25μL
of the liquid test substance at concentrations of 25, 50 and 100%
diluted with propylene glycol for three consecutive days. Mean
Disintegrations Per Minute (DPM) /animal values for the experimental
groups treated with the test material at 25, 50 and 100% were 468, 465
and 381 DPM, respectively. The mean DPM/animal value for the vehicle
control group was 450 DPM. The values were then used to calculate the
stimulation index (SI). The SI values calculated for the substance
concentrations 25, 50 and 100% were 1.0, 1.0 and 0.8, respectively. No
effects on ear puncture weight were observed.
results indicate that Vinasses (as defined in the "Category
justification Vinasses" document) are able to elicit an SI ≥ 3 in the
Local Lymph Node Assay. However, the results described above cannot
clearly be verified as sensitising effects, since skin irritation could
also induce an increase of the stimulation index. The fact that
stimulation indices above 3 were accompanied by increased auricular
lymph nodes and increased mean ear puncture weights, indicative of
inflammatory effects, supports this assumption.
the Local Lymph Node Assay cannot be considered as a predictive assay
for the sensitising properties of UVCB substances since it was developed
for and validated by testing of well-defined chemicals.
number of statements on in-house human experience are available from
occupational health physicians confirming that after working with
Vinasses for many years, none of the employees has reported any allergic
reactions so far, which could be attributed to Vinasses (Brouck and
Frimat, 2010; Rasi, 2010; Kosek, 2010; Carton, 2010, Sobkowiak, 2010;
Pieters, 2010; Hrušková, 2010; Buhre, 2010). Furthermore, up to now no
case of skin sensitisation is published in the literature.
This information is not available.
available data for the analogue substance on skin sensitisation is
inconclusive according to the criteria of 67/548/EEC (DSD) and
1272/2008/EC (CLP) since (i) the performed Local Lymph Node Assays
(LLNA) gave divergent even contradictory results, i. e. two negative and
two positive tests, (ii) it is arguable if the LLNA is the appropriate
animal test to analyse the sensitisation potential of such a complex
UVCB substance and (iii) there are no indications from practical
experience that Vinasses (as defined in the "Category justification Vinasses"
document) is capable of inducing skin sensitisation in humans.
Therefore, in order to assign a reliable classification to the
substance, it is proposed to wait the results of a Guinea Pig
Maximization Test (GPMT) according to OECD 406 proposed at ECHA for the
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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