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EC number: 932-215-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
Within the 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. Thus, read-across is performed based on a category approach (A detailed justification is attached in IUCLID section 13).
A 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 (Beerens-Heijnen, 2011a).
In 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.
Moreover, 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.
These results indicate that Vinasses 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.
Moreover, 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.
Human data
A 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.
Migrated from Short description of key information:
LLNA: positive in 2 tests (EC3 values of 57 and 74, respectively, therefore considered as a weak sensitiser in mice) and negative in 2 tests.
Human experience: not sensitising
Respiratory sensitisation
Endpoint conclusion
- Additional information:
This information is not available.
Justification for classification or non-classification
The available data for Vinasses 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 the substance is capable of inducing skin sensitisation in humans. Therefore, in order to assign a reliable classification to the substance, it is proposed to perform a Guinea Pig Maximization Test (GPMT) according to OECD 406.
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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