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EC number: 931-433-1 | CAS number: 8002-26-4
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:
- 2005-08-22 to 2005-09-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- 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
- IUPAC Name:
- 8002-26-4
- Reference substance name:
- Crude Tall Oil
- IUPAC Name:
- Crude Tall Oil
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- see Table 1
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: DMSO is a common vehicle for the Ames test.
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: 4-Nitro-o-phenylene-diamine
- Remarks:
- TA97a without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- TA97a with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 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:
- TA100 and TA1535 without activation
- 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:
- TA98, TA100 and TA1535 with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: t-Butyl-hydroperoxide
- Remarks:
- TA102 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1,8-Dihydroxy-anthraquinone
- Remarks:
- TA102 with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: triplicate for each dose group, six replicates for the solvent controls and three replicates for positive control.
DETERMINATION OF CYTOTOXICITY
- Method: other: reduced or no bacterial background lawn, microcolonies of bacteria instead of a homogenous background lawn, clearly reduced number of revertant colonies. - Evaluation criteria:
- A result would be considered positive if there was a reproducible increase in the number of revertants to more than 2.5 fold for strains TA98 and TA1538 and more than 1.33 fold for TA97a, TA100 and TA102.
- Statistics:
- The number of revertant colonies was counted by hand in strains TA98 and TA1535 and by a computer program in strains TA97a, TA100 and TA102. The mean and standard deviation of replicate results were calculated.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 185 μg/plate to strain TA97a
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A precipitate was visible at 556 μg/plate samples and above. The precipitate was still visible at 5000 μg/plate when the colonies were counted but did not impede the counting.
- Other confounding effects: the substance is known to be ready biodegradable.
RANGE-FINDING/SCREENING STUDIES: see Table 2
COMPARISON WITH HISTORICAL CONTROL DATA: numbers of spontaneous revertants are comparable with the historic control data for the negative controls. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2: Dose range-finding study. Number of revertants per plate (average of 2 plates).
|
TA 100 |
|
Concentration (μg/Plate) |
- MA |
Cytotoxic (Yes/No) |
21 |
93 |
No |
62 |
93 |
No |
185 |
81 |
No |
556 |
58 |
No |
1667 |
59 |
No |
5000 |
75 |
No |
Table 3: Experiment 1 Mutagenicity Assay. Number of revertants per plate (mean of 6 plates in solvent control, mean of 3 plates in the other exposure).
|
TA97a |
TA98 |
TA100 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
5000 |
- |
- |
Yes |
6.0 |
9.0 |
No |
42.7 |
46.3 |
No |
1667 |
0.0 |
9.7 |
Yes |
8.7 |
9.3 |
No |
44.3 |
48.0 |
No |
556 |
0.0 |
54.7 |
Yes |
6.3 |
8.0 |
No |
52.0 |
56.3 |
No |
185 |
67.7 |
110.3 |
No |
11.0 |
11.0 |
No |
66.3 |
69.7 |
No |
62 |
119.3 |
120.3 |
No |
9.3 |
9.3 |
No |
66.0 |
79.0 |
No |
0* |
607.0 |
140.5 |
No |
8.0 |
12.8 |
No |
73.5 |
77.0 |
No |
Positive control |
374.0 |
607.0 |
No |
109.7 |
415.7 |
No |
422.3 |
1955.0 |
No |
*solvent control with DMSO
Table 3 (continued): Experiment 1 Mutagenicity Assay. Number of revertants per plate (mean of 6 plates in the solvent control, mean of 3 plates in the other exposures).
|
TA102 |
TA1535 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
5000 |
66.3 |
127.0 |
Yes |
7.0 |
4.3 |
Yes |
1667 |
85.0 |
152.7 |
Yes |
7.3 |
7.7 |
Yes |
556 |
102.7 |
198.0 |
No |
11.0 |
10.7 |
No |
185 |
117.0 |
244.3 |
No |
22.0 |
16.3 |
No |
62 |
170.3 |
260.7 |
No |
17.7 |
18.7 |
No |
0* |
181.7 |
247.8 |
No |
20.0 |
18.2 |
No |
Positive control |
487.7 |
595.0 |
No |
207.0 |
196.7 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Mutagenicity Assay. Number of revertants per plate )mean of 6 plates per solvent control, mean of 3 plates in other exposures).
|
TA97a |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
556 |
4.3 |
8.3 |
Yes |
185 |
32.7 |
102.7 |
No |
62 |
102.3 |
108.3 |
No |
21 |
110.0 |
103.7 |
No |
7 |
109.3 |
135.0 |
No |
2.3 |
118.0 |
122.7 |
No |
0* |
85.8 |
110.7 |
No |
Positive control |
229.7 |
351.7 |
No |
*solvent control withDMSO
Table 4 (continued): Experiment 2 Mutagenicity Assay. Number of revertants per plate (mean of 6 plates per solvent control, mean of 3 plates in other exposures).
|
TA98 |
TA100 |
TA100 |
||||||
Conc. |
— MA |
+MA |
Cytotoxic |
—MA |
+MA |
Cytotoxic |
—MA |
+MA |
Cytotoxic |
5000 |
6.3 |
7.3 |
No |
54.7 |
56.0 |
No |
54.7 |
56.0 |
No |
1667 |
5.7 |
6.7 |
No |
57.3 |
61.3 |
No |
57.3 |
61.3 |
No |
556 |
5.3 |
8.0 |
No |
59.0 |
68.0 |
No |
59.0 |
68.0 |
No |
185 |
5.7 |
10.7 |
No |
69.0 |
79.0 |
No |
69.0 |
79.0 |
No |
62 |
5.3 |
11.3 |
No |
69.0 |
77.0 |
No |
68.0 |
77.0 |
No |
0* |
7.7 |
11.8 |
No |
86.5 |
69.5 |
No |
86.5 |
69.5 |
No |
Positive control |
207.3 |
359.3 |
No |
253.0 |
1372.0 |
No |
253.0 |
1372.0 |
No |
*solvent control withDMSO
Table 4 (continued): Experiment 2 Mutagenicity Assay. Number of revertants per plate (mean of 6 plates per solvent control, mean of 3 plates in other exposures).
|
TA102 |
TA1535 |
||||
Conc. |
—MA |
+MA |
Cytotoxic |
—MA |
+MA |
Cytotoxic |
5000 |
34.7 |
85.3 |
Yes |
5.0 |
4.7 |
Yes |
1667 |
45.3 |
100.3 |
Yes |
6.3 |
7.3 |
Yes |
556 |
51.3 |
125.7 |
Yes |
10.7 |
12.0 |
No |
185 |
80.0 |
149.7 |
No |
15.0 |
17.0 |
No |
62 |
86.0 |
166.3 |
No |
183 |
19.7 |
No |
0* |
112.5 |
147.8 |
No |
15.7 |
17.7 |
No |
Positive control |
344.0 |
615.0 |
No |
158.0 |
163.0 |
No |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance did not produce an increase in the number of revertants in S. typhimurium (strains TA97a, TA98, TA100, TA102 and TA1535) 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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