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EC number: 272-347-8 | CAS number: 68814-95-9
- 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
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- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
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- Endpoint summary
- Stability
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- 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
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- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- OECD guideline study conducted in compliance with GLP regulations, with acceptable restrictions (neither E. coli strain WP2 uvrA nor S. typhimurium strain TA102 were employed in this study for the detection of oxidising mutagens and cross-linking agents)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 1983)
- Deviations:
- yes
- Remarks:
- (neither E. coli strain WP2 uvrA pKM101a nor S. typhimurium strain TA102 were employed in this study for the detection of oxidising mutagens and cross-linking agents; 2-aminoanthracene used as sole indicator of the efficacy of the S9 mix)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amines, tri-C8-10-alkyl
- EC Number:
- 272-347-8
- EC Name:
- Amines, tri-C8-10-alkyl
- Cas Number:
- 68814-95-9
- Molecular formula:
- Unspecified
- IUPAC Name:
- Amine, tri(n-C8,C10-alkyl)
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Alamine 336
- Physical state: liquid, colourless
- Analytical purity: 100 % (active substance)
- Lot/batch No.: 5J167
- Expiration date of the lot/batch: February 2000
- Stability under test conditions: stable for 12 months
- Storage condition of test material: at room temperature
- SAT-No.: 990409
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/B-Naphthoflavone induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 1st and 2nd assay: 8, 40, 200, 1000 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/bidest. water
- Justification for choice of solvent/vehicle: The suspension medium was chosen according to the solubility properties tested preliminary before start of the study.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated cell suspension
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tween 80/bidest. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 12 hours
NUMBER OF REPLICATIONS: triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: background lawn
DETAILS ON CONTROLS:
- Negative controls: suspension medium Tween 80/bidist. water and the untreated fresh cell suspensions
- Positive controls:
- Without metabolic activation:
sodium azide (2 µg/plate) for TA 100 and TA 1535;
9-aminoacridine (80 µg/plate) for TA 1537
4-nitro-o-phenylendiamine (40 µg/plate) for TA 98 and TA 1538
- With metabolic activation:
2-aminoanthracene in all strains (2.5 µg/plate for TA 1535, TA 1537; 5.0 µg/plate for TA 100, TA 98, TA 1538)
- Sterility controls:
The test batches containing S9-mix were each controlled for sterility by adding 0.5 mL of S9-mix fraction to untreated agar plates.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium 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
- Species / strain:
- S. typhimurium TA 1535
- 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
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 1538
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
RESULTS:
Experiment 1 |
|||||||||||||||||||||||||||
Treatment groups |
[µg/plate] |
Strains |
|||||||||||||||||||||||||
|
|
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
|||||||||||||||||||||
|
|
- |
SD |
+ |
SD |
- |
SD |
+ |
SD |
- |
SD |
+ |
SD |
- |
SD |
+ |
SD |
- |
SD |
+ |
SD |
||||||
medium |
- |
108 |
6 |
125 |
15 |
9 |
3 |
18 |
12 |
16 |
5 |
10 |
0 |
10 |
4 |
11 |
6 |
19 |
8 |
32 |
2 |
||||||
solvent |
- |
129 |
15 |
117 |
14 |
10 |
1 |
13 |
1 |
17 |
5 |
11 |
3 |
8 |
1 |
12 |
7 |
22 |
6 |
25 |
4 |
||||||
test substance |
8 |
121 |
18 |
137 |
17 |
10 |
2 |
11 |
3 |
14 |
3 |
20 |
2 |
10 |
3 |
9 |
6 |
29 |
8 |
22 |
3 |
||||||
40 |
121 |
15 |
134 |
16 |
14 |
5 |
14 |
4 |
9 |
2 |
13 |
4 |
15 |
5 |
11 |
2 |
24 |
3 |
27 |
2 |
|||||||
200 |
115 |
12 |
113 |
17 |
7 |
2 |
11 |
3 |
14 |
1 |
4 |
3 |
13 |
3 |
15 |
3 |
23 |
8 |
31 |
5 |
|||||||
1000 |
113 |
11 |
98 |
9 |
9 |
1 |
11 |
6 |
13 |
3 |
12 |
3 |
8 |
3 |
11 |
3 |
20 |
4 |
29 |
5 |
|||||||
5000 |
106 |
8 |
87 |
16 |
11 |
4 |
7 |
4 |
5 |
1 |
5 |
2 |
11 |
5 |
14 |
1 |
14 |
3 |
22 |
7 |
|||||||
positive controls |
A |
736 |
40 |
302 |
6 |
542 |
8 |
222 |
13 |
906 |
59 |
463 |
56 |
2421 |
54 |
1784 |
75 |
1718 |
100 |
1381 |
166 |
||||||
B |
148 |
13 |
2990 |
18 |
11 |
1 |
194 |
35 |
15 |
6 |
181 |
15 |
17 |
3 |
1992 |
122 |
19 |
3 |
2125 |
110 |
|||||||
Experiment 2 |
|||||||||||||||||||||||||||
Treatment groups |
[µg/plate] |
Strains |
|||||||||||||||||||||||||
|
|
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
|||||||||||||||||||||
|
|
- |
SD |
+ |
SD |
- |
SD |
+ |
SD |
- |
SD |
+ |
SD |
- |
SD |
+ |
SD |
- |
SD |
+ |
SD |
||||||
medium |
- |
103 |
12 |
116 |
15 |
8 |
5 |
10 |
2 |
14 |
5 |
20 |
7 |
13 |
7 |
18 |
8 |
23 |
3 |
20 |
6 |
||||||
solvent |
- |
111 |
15 |
96 |
16 |
24 |
2 |
9 |
3 |
10 |
2 |
12 |
1 |
16 |
7 |
12 |
2 |
26 |
4 |
24 |
2 |
||||||
test substance |
8 |
115 |
6 |
117 |
15 |
14 |
7 |
16 |
1 |
10 |
1 |
15 |
5 |
10 |
3 |
17 |
6 |
23 |
0 |
23 |
6 |
||||||
40 |
111 |
3 |
125 |
24 |
12 |
4 |
15 |
4 |
14 |
3 |
10 |
4 |
13 |
1 |
14 |
3 |
23 |
2 |
28 |
2 |
|||||||
200 |
106 |
11 |
119 |
23 |
15 |
2 |
13 |
5 |
7 |
1 |
8 |
3 |
13 |
4 |
13 |
3 |
21 |
2 |
30 |
5 |
|||||||
1000 |
81 |
11 |
82 |
3 |
12 |
5 |
10 |
1 |
7 |
2 |
9 |
5 |
12 |
4 |
12 |
3 |
13 |
2 |
23 |
2 |
|||||||
5000 |
82 |
11 |
86 |
9 |
152 |
2 |
12 |
6 |
8 |
3 |
10 |
5 |
8 |
2 |
11 |
1 |
13 |
1 |
25 |
2 |
|||||||
positive controls |
A |
764 |
19 |
165 |
22 |
615 |
21 |
76 |
9 |
409 |
120 |
112 |
28 |
2387 |
235 |
1227 |
297 |
1587 |
21 |
872 |
96 |
||||||
B |
118 |
9 |
943 |
91 |
27 |
9 |
115 |
25 |
18 |
4 |
78 |
8 |
16 |
1 |
951 |
123 |
27 |
6 |
727 |
75 |
|||||||
-: without metabolic activation
+: with metabolic activation
SD: standard deviation
Positive controls: A: TA 1535, TA 100: sodium azide
TA 1537: 9-aminoacridine
TA 1538, TA 98: 4-nitro-o-phenylenediamine
B : TA 1535, TA 1537: 2-aminoanthracene
TA 100, TA 1538, TA 98: 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Amines, tri-C8-10-alkyl is considered not to be mutagenic in this bacterial mutagenicity test in vitro. - Executive summary:
The test item with the batch number 5J167 was tested in the Salmonella typhimurium Reverse Mutation Assay for the induction of reverse mutations in a bacterial test system. The assay was performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in two independent experiments, both with and without metabolic activation by S9-mix according to OECD 471 (BASF SE, 1999, 9901542).
Solutions of the test substance were prepared in Tween 80/bidist. water and diluted with Tween 80/bidist. water just before use. The following concentrations were tested:
1st and 2nd test: 8, 40, 200, 1000 and 5000 µg/plate
The direct plate incorporation assay was utilized. The following results were obtained:
Toxic effects were not noted. No enhanced revertant rates compared to concurrent negative controls were observed in all tested strains, neither in the presence nor in the absence of metabolic activation.
Therefore the test substance did not induce reverse mutations in the tested strains of Salmonella typhimurium in this bacterial mutagenicity test.
In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test substance did not induce gene mutations in Salmonella typhimurium strains.
Subsequently, Amines, tri-C8-10-alkyl is considered not to be mutagenic in this
bacterial mutagenicity test in vitro.
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