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Diss Factsheets
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EC number: 932-179-4 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 10 Sep - 05 Oct 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- 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): LUCULLUS 235/02
- Physical state / appearance: brown pasty mass
- Analytical purity: 100%
- Lot/batch No.: Lot 235/04
- Storage condition of test material: at +4°C
The test substance is a proteinic basis, whose intended use being for the preparation of reaction flavours.
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 102, TA 98, TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, S9 fraction comes from liver homogenates from rats induced with Aroclor 1254 (500 mg/kg)
- Test concentrations with justification for top dose:
- 312.5, 625, 1250, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Concentration of the test substance in solvent: 50 mg/mL
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9 mix: sodium azide (TA 1535, TA 100), 9-Aminoacridine (TA 1537), 2-Nitrofluorene (TA 98), mitomycin C (TA 102); with S8 mix: 2-Anthramine (TA 1535, TA 1537, TA 98, TA 100), Danthron (TA 102)
- Remarks:
- with and without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: direct in agar (plate incorporation) both tests without S9 mix, first test with S9 mix
preincubation method: second test with S9 mix described by Maron and Ames, 1983
DURATION
- Preincubation period: 60 minutes at 37°C
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 2 per dose
DETERMINATION OF TOXICITY
- Method: relative total growth, preliminary test - Evaluation criteria:
- For determining a positive response:
- a reproducible and significant dose relationship using a linear regression analysis, considered as significant if p <= 0.05 (for n = 18 values, the correlation coefficient must be r >= 0.47)
and/or
- a reproducible and significant increase (i.e. a doubling in the number of revertants for at least one of the tested strains when compared to that of the negative and/or solvent controls) for at least one of the tested concentrations.
A test substance is considered as non-mutagenic in this test system if the above two criteria are not fully met. - Statistics:
- Biological and statistical significances were considered during the evaluation.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 102, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
RANGE-FINDING/SCREENING STUDIES: preliminary toxicity test (10, 100, 1000, 2500 and 5000 µg/plate)
COMPARISON WITH HISTORICAL CONTROL DATA: yes, in the range
ADDITIONAL INFORMATION ON TOXICITY: The test substance was not toxic at the concentrations used.- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The number of revertants obtained in the presence of LUCULLUS 235/02 - Batch No 235/04, with and without S9 mix, for the 5 strains was equivalent to that of the negative (untreated) and/or solvent controls.
Table 1: Lucullus 235/02 Batch No. 235/04: Results of the first and second mutagenicity test with and without metabolic activation
1st experiment |
number of revertants: mean value of negative control |
number of revertants: mean value of positive control |
max. number of revertants and concentration max. number appeared at [µg/plate] |
without S9-mix |
|
|
|
TA 1535 |
9 ± 2 |
576 ± 20 |
12 ± 2 [625] |
TA 1537 |
7 ± 1 |
224 ± 33 |
10 ± 1 [2500] |
TA 102 |
315 ± 18 |
1668 ± 88 |
358 ± 49 [625] |
TA 98 |
18 ± 1 |
159 ± 7 |
25 ± 4 [0] |
TA 100 |
115 ± 3 |
458 ± 13 |
111 ± 10 [5000] |
with S9-mix |
|
|
|
TA 1535 |
12 ± 2 |
411 ± 57 |
13 ± 2 [625] |
TA 1537 |
8 ± 2 |
456 ± 22 |
10 ± 1 [1250] |
TA 102 |
369 ± 27 |
931 ± 69 |
400 ± 12 [5000] |
TA 98 |
25 ± 8 |
1927 ± 59 |
21 ± 2 [625] |
TA 100 |
125 ± 2 |
2104 ± 99 |
126 ± 12 [1250] |
2nd experiment |
number of revertants: mean value of negative control |
number of revertants: mean value of positive control |
max. number of revertants and concentration max. number appeared at [µg/plate] |
without S9-mix |
|
|
|
TA 1535 |
9 ± 2 |
359 ± 17 |
11 ± 3 [312.5, 625, 5000] |
TA 1537 |
9 ± 2 |
186 ± 12 |
13 ± 5 [2500, 5000] |
TA 102 |
226 ± 9 |
1490 ± 157 |
295 ± 49 [1250] |
TA 98 |
25 ± 3 |
170 ± 13 |
31 ± 4 [0] |
TA 100 |
105 ± 9 |
603 ± 66 |
119 ± 18 [0] |
with S9-mix |
|
|
|
TA 1535 |
12 ± 2 |
118 ± 9 |
14 ± 5 [5000] |
TA 1537 |
7 ± 1 |
155 ± 19 |
9 ± 5 [2500] |
TA 102 |
259 ± 3 |
933 ± 55 |
395 ± 8 [5000] |
TA 98 |
19 ± 1 |
969 ± 62 |
20 ± 3 [5000] |
TA 100 |
94 ± 7 |
1392 ± 76 |
111± 17 [1250] |
Under the experimental conditions the test substance did not show mutagenic activity in the Ames test.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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