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EC number: 266-942-1 | CAS number: 67701-23-9
- 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:
- Salmonella Typhimurium Reverse Mutation Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-08-22 - 2005-09-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Justification for read-across, see attached file.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 july, 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tall oil
- EC Number:
- 232-304-6
- EC Name:
- Tall oil
- Cas Number:
- 8002-26-4
- Molecular formula:
- Not applicable - UVCB substance
- Test material form:
- liquid: viscous
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA153
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Test substance (all strains: 1st experiment; TA98, TA100, TA102 and TA1535: 2nd experiment)
Dose: 5000, 1667, 556, 185 and 62 µg/plate
Number of samples: 3 samples
Test substance (TA97a: 2nd experiment)
Dose: 556, 185, 62, 21, 7 and 2.3 µg/plate
Number of samples: 3 samples
Justification: The concentrations for the first experiment were set according to a preliminary toxicity test, see 3.2.
The test substance was not toxic up to 5000 µg/petri dish.
It was therefore decided to use 5000 µg/plate as the highest concentration which is the limit concentration according to the guidelines. Each of the other 4 concentrations was 1/3 of the preceding one.
For the second experiment the concentrations were changed only for strain TA97a according to the first experiment. The test substance was toxic to strain TA97a at 5000 and 1667 µg/plate. Thus it was decided to use 556 µg/plate as the highest concentration for the second experiment, which could be in the toxic range and to use a total of 6 concentrations.
The number and intervals of the concentrations are in accordance with the guidelines (at least 5 concentrations with intervals of about 10 ).
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylene-diamine, t-Butyl-hydroperoxide, 2- Aminoanthracene, 1,8-Dihydroxy-anthraquinone, 7,12-Dimethylbenz[a]anthracene, 2-Nitrofluorene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- In the preliminary test with strain TA100 no toxicity was seen up to 5000 µg/plate.
In the main test the test substance was only toxic to strain TA97a, resulting in a completely or almost missing bacterial background lawn at 5000 and 1667 µg/plate. At 556 µg/plate and beneath the bacterial background was normal.
Applicant's summary and conclusion
- Conclusions:
- According to these results, "CRUDE TALL OIL" is not mutagenic in the Ames test with the strains of Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without an external metabolising system up to 5000 µg/plate.
- Executive summary:
Method
"CRUDE TALL OIL" was tested for mutagenic activity with the "Salmonella typhimurium Reverse Mutation Test" (Ames Test). The study was conducted in accordance with the OECD-guideline 471 and directive 2000/32/EC, part B.13/14.
The test substance was dissolved in DMSO. The following concentrations were tested:
62, 185, 556, 1667 and 5000 µg per plate without external metabolisation, and
62, 185, 556, 1667 and 5000 µg per plate with S9-mix from Aroclor 1254 induced microsomes of rat liver as an external metabolising system.
In the second experiment the concentrations were changed for strain TA97a as follows:
2.3, 7, 21, 62, 185 and 556 µg per plate without external metabolisation, and
2.3, 7, 21, 62, 185 and 556 µg per plate with S9-mix from Aroclor 1254 induced microsomes of rat liver as an external metabolising system.
The test was performed according to the "direct plate incorporation method". As test system the bacterial strains Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used. Negative and positive controls were included. An independent repetition of the experiment was performed.
Results
Positive controls:
All positive control groups showed significantly increased mutation frequencies which demonstrate the sensitivity of the test system.
Test substance:
Toxicity:
The test substance was toxic only to strain TA97a, resulting in a completely or almost missing bacterial background lawn at 5000 and 1667 µg/plate. At 556 µg/plate and beneath the bacterial background was normal. No toxicity was noted in the other strains.
Solubility:
At the 5000, 1667 and 556 µg/plate samples a precipitate was visible when the test substance was mixed with the agar. At 5000 µg/plate the precipitate was still visible when the colonies were counted but did not impede the counting.
Mutagenicity:
In none of the concentrations tested and with none of the strains used an increase of the mutation frequency to more than the threshold values (250 % of the controls for strains TA98 and TA1535, 167 % of the controls for strains TA97a, TA100 and TA102) was obtained. Metabolic activation did not change these results.
Conclusion
According to the results obtained in this study, "CRUDE TALL OIL" is non-mutagenic in the Ames test with the strains TA97a, TA98, TA100, TA102 and TA1535 with and without an external metabolising system up to 5000 µg/plate.
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