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EC number: 825-518-1 | CAS number: 2060541-47-9
- 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:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 January 1993 - 26 January 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed under GLP and according to international guidelines. However in the current guideline E.coli WP2 strains or S. typhimurium TA102 have to be included. With this test it is not possible to identify certain oxidising mutagens, cross-linking agents and hydrazines. Such substances may be detected by E.coli WP2 strains or S. typhimurium TA102 which have an AT base pair at the primary reversion site in stead of GC base pairs which the strains tested in this study have.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Principles of method if other than guideline:
- In the current guideline E.coli WP2 strains or S. typhimurium TA102 have to be included. With this test it is not possible to identify certain oxidising mutagens, cross-linking agents and hydrazines. Such substances may be detected by E.coli WP2 strains or S. typhimurium TA102 which have an AT base pair at the primary reversion site in stead of GC base pairs which the strains tested in this study have.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- EC Number:
- 307-458-3
- EC Name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- Cas Number:
- 97659-53-5
- Details on test material:
- Name: Ampholak 7TX
Chemicals name: Amines, N-tallowalkyl-polytrimethylene-poly-, carboxymethylderivates, sodium salt
CAS No.: 97659-53-5
Batch No.: BX 3719
Appearance: pale yellow viscous liquid
Storage: clear glass jar, ambient room temperature in the dark
Constituent 1
Method
- Target gene:
- Gene coding for histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: see below in section any other information on materials and methods
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 50, 158, 500, 1580 and 5000 µg/plate
- Vehicle / solvent:
- puirifed water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 2-aminoanthracene, 9-aminoacridine, 2-nitrofuorene, Benzo[a]pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 days
SELECTION AGENT (mutation assays): histidine defiecient medium
NUMBER OF REPLICATIONS: Triplicate plates per concentration
NUMBER OF CELLS EVALUATED: After incubation, numbers of revertant colonies were counted manually. Total colonies on nutrient plates were counted in the same way. Growth of the background lawn of non-revertant cells on minimal plates was verified.
DETERMINATION OF CYTOTOXICITY
- Method: a study was per formed with strain TA98 at 2.5, 5, 25, 50, 250, 500, 2500 and 5000 µg/plate, otherwise same methods as the main study. - Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
Mutation test 1
strain |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
SD |
TA98 |
5000 |
+ |
36 |
3 |
1580 |
+ |
42 |
12 |
|
5500 |
+ |
42 |
4 |
|
158 |
+ |
39 |
5 |
|
50 |
+ |
37 |
5 |
|
0 |
+ |
37 |
6 |
|
5000 |
- |
25 |
5 |
|
1580 |
- |
22 |
2 |
|
5500 |
- |
26 |
3 |
|
158 |
- |
28 |
6 |
|
50 |
- |
25 |
1 |
|
0 |
- |
24 |
4 |
|
TA100 |
5000 |
+ |
121 |
3 |
1580 |
+ |
130 |
12 |
|
5500 |
+ |
122 |
9 |
|
158 |
+ |
120 |
20 |
|
50 |
+ |
113 |
4 |
|
0 |
+ |
126 |
12 |
|
5000 |
- |
69 |
20 |
|
1580 |
- |
139 |
10 |
|
5500 |
- |
107 |
4 |
|
158 |
- |
108 |
6 |
|
50 |
- |
110 |
6 |
|
0 |
- |
138 |
10 |
|
TA1535 |
5000 |
+ |
12 |
3 |
1580 |
+ |
11 |
3 |
|
5500 |
+ |
16 |
2 |
|
158 |
+ |
13 |
3 |
|
50 |
+ |
9 |
1 |
|
0 |
+ |
12 |
1 |
|
5000 |
- |
0 |
0 |
|
1580 |
- |
9 |
2 |
|
5500 |
- |
8 |
2 |
|
158 |
- |
15 |
2 |
|
50 |
- |
12 |
3 |
|
0 |
- |
11 |
3 |
|
TA1537 |
5000 |
+ |
15 |
3 |
1580 |
+ |
12 |
3 |
|
5500 |
+ |
9 |
4 |
|
158 |
+ |
6 |
2 |
|
50 |
+ |
8 |
3 |
|
0 |
+ |
12 |
3 |
|
5000 |
- |
13 |
2 |
|
1580 |
- |
11 |
3 |
|
5500 |
- |
9 |
1 |
|
158 |
- |
6 |
3 |
|
50 |
- |
8 |
4 |
|
0 |
- |
8 |
2 |
- Absence
+ Presence
SD Standard deviation
Positive control Mutation test 1:
Strain |
Compound |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
SD |
TA98 |
Benzo[a]pyrene |
5 |
- |
22 |
9 |
TA98 |
Benzo[a]pyrene |
5 |
+ |
544 |
29 |
TA98 |
2-nitrofluorne |
1 |
- |
138 |
5 |
TA100 |
Benzo[a]pyrene |
5 |
- |
110 |
10 |
TA100 |
Benzo[a]pyrene |
5 |
+ |
829 |
70 |
TA100 |
Sodium azide |
2 |
- |
969 |
14 |
TA1535 |
2-aminoanthracene |
2 |
- |
153 |
47 |
TA1535 |
2-aminoanthracene |
2 |
+ |
247 |
44 |
TA1535 |
Sodium azide |
2 |
- |
180 |
11 |
TA1537 |
Benzo[a]pyrene |
5 |
- |
14 |
3 |
TA1537 |
Benzo[a]pyrene |
5 |
+ |
222 |
23 |
TA1537 |
9-aminoacridine |
80 |
- |
201 |
75 |
- Absence
+ Presence
SD Standard deviation
Mutation test 2:
strain |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
SD |
TA98 |
5000 |
+ |
35 |
9 |
1580 |
+ |
41 |
3 |
|
5500 |
+ |
41 |
8 |
|
158 |
+ |
45 |
11 |
|
50 |
+ |
36 |
5 |
|
0 |
+ |
40 |
7 |
|
5000 |
- |
15 |
3 |
|
1580 |
- |
21 |
5 |
|
5500 |
- |
22 |
4 |
|
158 |
- |
25 |
5 |
|
50 |
- |
22 |
6 |
|
0 |
- |
30 |
9 |
|
TA100 |
5000 |
+ |
76 |
15 |
1580 |
+ |
113 |
6 |
|
5500 |
+ |
105 |
3 |
|
158 |
+ |
80 |
12 |
|
50 |
+ |
74 |
4 |
|
0 |
+ |
98 |
7 |
|
5000 |
- |
15 |
3 |
|
1580 |
- |
73 |
16 |
|
5500 |
- |
93 |
5 |
|
158 |
- |
90 |
11 |
|
50 |
- |
89 |
3 |
|
0 |
- |
91 |
6 |
|
TA1535 |
5000 |
+ |
11 |
4 |
1580 |
+ |
7 |
2 |
|
5500 |
+ |
8 |
1 |
|
158 |
+ |
9 |
3 |
|
50 |
+ |
13 |
4 |
|
0 |
+ |
11 |
4 |
|
5000 |
- |
2 |
1 |
|
1580 |
- |
6 |
2 |
|
5500 |
- |
11 |
1 |
|
158 |
- |
9 |
3 |
|
50 |
- |
9 |
1 |
|
0 |
- |
10 |
3 |
|
TA1537 |
5000 |
+ |
2 |
1 |
1580 |
+ |
9 |
4 |
|
5500 |
+ |
11 |
2 |
|
158 |
+ |
8 |
1 |
|
50 |
+ |
9 |
4 |
|
0 |
+ |
11 |
2 |
|
5000 |
- |
7 |
1 |
|
1580 |
- |
3 |
1 |
|
5500 |
- |
9 |
3 |
|
158 |
- |
8 |
3 |
|
50 |
- |
7 |
1 |
|
0 |
- |
7 |
1 |
- Absence
+ Presence
SD Standard deviation
Positive control Mutation test 2:
Strain |
Compound |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
SD |
TA98 |
Benzo[a]pyrene |
5 |
- |
22 |
5 |
TA98 |
Benzo[a]pyrene |
5 |
+ |
525 |
46 |
TA98 |
2-nitrofluorne |
1 |
- |
147 |
28 |
TA100 |
Benzo[a]pyrene |
5 |
- |
79 |
17 |
TA100 |
Benzo[a]pyrene |
5 |
+ |
565 |
219 |
TA100 |
Sodium azide |
2 |
- |
723 |
151 |
TA1535 |
2-aminoanthracene |
2 |
- |
9 |
0 |
TA1535 |
2-aminoanthracene |
2 |
+ |
255 |
94 |
TA1535 |
Sodium azide |
2 |
- |
938 |
14 |
TA1537 |
Benzo[a]pyrene |
5 |
- |
6 |
3 |
TA1537 |
Benzo[a]pyrene |
5 |
+ |
189 |
21 |
TA1537 |
9-aminoacridine |
80 |
- |
169 |
70 |
- Absence
+ Presence
SD Standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Ampholak 7TX was devoid of mutagenic activity under the conditions of test. - Executive summary:
An Ames test was performed according to OECD471, EPA Toxic Substances Control Act Test Guideline 798.5265 (1987) and EC Annex V B.14. The study complies with GLP. The studies, which were conducted in the presence and absence of an activating system derived from rat liver (S-9 mix), employed a range of levels of Ampholak 7TX in purified water from 50 to 5000 µg per plate, selected following a preliminary toxicity test in strain TA98. All tests included solvent (purified water) controls with and without S-9 mix.No increases in reversion to prototrophy were obtained with any of the four bacterial strains at the Ampholak 7TX levels tested, either in the presence or absence of S-9 mix. Inhibition of growth, observed as a reduction in revertant colony numbers, occurred in all strains following exposure to Ampholak 7TX at 5000 µg per plate on at least one occasion of testing.
Marked increases in the number of revertant colonies were induced by the known mutagens benzo[a]pyrene, 2 -nitrofluorene, 2 -aminoanthracene, 9 -aminoacridine, and sodium azide when examined under similar conditions. It was concluded that Ampholak 7TX was devoid of mutagenic activity under the conditions of test.
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