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EC number: 232-304-6 | CAS number: 8002-26-4 A complex combination of tall oil rosin and fatty acids derived from acidulation of crude tall oil soap and including that which is further refined. Contains at least 10% rosin.
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-04-17 to 2009-12-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Tall Oil
- Stability under test conditions: stable
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver (S9 mix)
- Test concentrations with justification for top dose:
- 17, 50 167, 500, 1667 and 5000 μg per plate.
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA 1535, TA 1537, TA 98 , TA 100 and E. coli with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- E. coli without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 and TA 100 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DSMO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without activation
- Details on test system and experimental conditions:
METHOD OF APPLICATION: plate incorporation (Experiment 1) and preincubation (Experiment 2).
DURATION
- Preincubation period: 20 min at 37 degC
- Exposure duration: 2 or 3 days
NUMBER OF REPLICATIONS: 3 plated per concentration and strain in the mutagenicity test, and one replicate in the toxicity test.
DETERMINATION OF CYTOTOXICITY
- Method: other: thinning of the background lawn of microcolonies and large size of resistant colonies.- Evaluation criteria:
- For S. typhimurium strains TA 1535, TA 1537, TA 98 and E.coli at least a doubling of the mean concurrent vehicle control values at some consideration of the test item. For S. typhimurium strain TA 100, a 1.5 fold increase over the control value was considered significant. If the mean colony count on the vehicle control plates was <10, then a value of 10 was assumed and minimum count of 20 was required before a significant mutagenic response was registered.
- Statistics:
- The number of revertant colonies was counted by hand.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A high level of precipitate was visible at 1667 and 5000 μg/plate in both the presence and absence of S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA: numbers of spontaneous revertants are comparable with the historic control data for the negative controls.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxicity to bacteria was observed although the precipitation at 5000 μg/plate was too dense to assess the condition of background lawn accurately. See table 4 for details. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2a. Experiment 1 - Mutagenicity Assay. Number of revertants per plate (mean of 3 plates).
Strain | TA 1535 | TA 1537 | TA 98 | ||||||
Conc. (μg/plate) | - MA | + MA | Cytotoxic (yes/no) | - MA | + MA | Cytotoxic (yes/no) | - MA | + MA | Cytotoxic (yes/no) |
0* | 10 | 11 | no | 5 | 7 | no | 11 | 17 | no |
17 | 8 | 14 | no | 2 | 9 | no | 9 | 20 | no |
50 | 9 | 11 | no | 4 | 10 | no | 12 | 16 | no |
167 | 10 | 10 | no | 5 | 10 | no | 15 | 18 | no |
500 | 10 | 9 | no | 7 | 5 | no | 7 | 17 | no |
1667 | 10 | 9 | no | 4 | 5 | no | 14 | 15 | no |
5000 | 7** | 11** | no | 3** | 4** | no | 6** | 11** | no |
Positive control | 325 | 378 | no | 2531 | 258 | no | 387 | 716 | no |
* = solvent control with DMSO
** = with precipitation, precipitation too dense to assess background lawn accurately - assumed to be normal.
Table 2b. Experiment 1 - Mutagenicity Assay. Number of revertants per plate (mean of 3 plates).
Strain |
TA 100 |
WP2uvrA |
||||
Conc. (μg/plate) |
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
85 |
118 |
no |
8 |
11 |
no |
17 |
99 |
110 |
no |
11 |
10 |
no |
50 |
109 |
101 |
no |
8 |
10 |
no |
167 |
105 |
129 |
no |
9 |
6 |
no |
500 |
92 |
100 |
no |
6 |
9 |
no |
1667 |
91 |
100 |
no |
10 |
15 |
no |
5000 |
102** |
104** |
no |
6** |
5** |
no |
Positive control |
1025 |
1090 |
no |
355 |
643 |
no |
* = solvent control with DMSO
** = with precipitation, precipitation too dense to assess background lawn accurately - assumed to be normal.
Table 3a. Experiment 2 - Mutagenicity Assay. Number of revertants per plate (mean of 3 plates).
Strain |
TA 1535 |
TA 1537 |
TA 98 |
||||||
Conc. (μg/plate) |
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
12 |
14 |
no |
12 |
10 |
no |
21 |
22 |
no |
17 |
14 |
20 |
no |
4 |
10 |
no |
14 |
23 |
no |
50 |
11 |
21 |
no |
4 |
7 |
no |
13 |
21 |
no |
167 |
14 |
16 |
no |
6 |
11 |
no |
19 |
22 |
no |
500 |
17 |
10 |
no |
9 |
11 |
no |
14 |
18 |
no |
1667 |
10 |
11 |
no |
7STLP |
9 P |
no |
15P |
15P |
no |
5000 |
14** |
16** |
no |
2TLP |
5** |
no |
14** |
17** |
no |
Positive control |
417 |
223 |
no |
219.1 |
252 |
no |
374 |
452 |
no |
* = solvent control with DMSO
** = with precipitation, precipitation too dense to assess background lawn accurately - assumed to be normal.
STLP - slightly thin lawn, with precipitation
TLP = thin lawn, precipitation
P = with precipitation
Table 3b. Experiment 2 - Mutagenicity Assay. Number of revertants per plate (mean of 3 plates).
Strain |
TA 100 |
WP2uvrA |
||||
Conc. (μg/plate) |
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
102 |
123 |
no |
16 |
12 |
no |
17 |
99 |
117 |
no |
11 |
14 |
no |
50 |
107 |
136 |
no |
11 |
14 |
no |
167 |
101 |
128 |
no |
12 |
13 |
no |
500 |
110 |
101 |
no |
11 |
12 |
no |
1667 |
105 |
97P |
no |
9P |
11P |
no |
5000 |
99** |
108** |
no |
8** |
11** |
no |
Positive control |
1142 |
586 |
no |
355 |
874 |
no |
* = solvent control with DMSO
** = with precipitation, precipitation too dense to assess background lawn accurately - assumed to be normal.
P = with precipitation.
Table 4. Toxicity test results with strain TA 100.
Concentration (μg/plate) | Cell count - MA | Cell count + MA |
0* | 119 | 108 |
17 | 107 | 104 |
50 | 123 | 105 |
167 | 125 | 102 |
500 | 97 | 103 |
1667 | 126 |
108P |
5000 | 98** | 86** |
* = solvent control with DMSO
** = precipitation too dense to assess background lawn accurately - assumed to be normal.
P = precipitation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test substance did not produce an increase in the number of revertants in S. typhimurium (strains TA 1535, TA 1537, TA 98 and TA 100) and E. coli WP2 uvr A when tested under GLP to OECD 471 (2000). The test material was therefore considered to be non-mutagenic under the conditions of this test.
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