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EC number: 825-403-6 | CAS number: 2060541-51-5
- 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:
- 3 - 20 September 1993.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was performed under GLP and according to OECD guideline from 1983. 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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Principles of method if other than guideline:
- This study was performed according to OECD guideline from 1983. 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:
- Identity: Arnpholak 7CX
Chemical name: Amines, N-cocoalkyl-polytrimethylene poly, carboxymethyl-sodium salts
Batch number: FP91327
Purity: Active about 27 %
Sodium glycolate max 3 %
Sodium chloride max 12%
Sodium monochloroacetate max 100 ppm
Water ad 100%
Appearance: clear yellow liquid
Storage conditions: room temperature
Constituent 1
Method
- Target gene:
- mutation in the gene coding for histidine
Species / strain
- Species / strain / cell type:
- other: see below
- Details on mammalian cell type (if applicable):
- S. typhimurium TA 1535 hisG46 rfa uvrB
S. typhimurium TA 1537 hisC3076 rfa uvrB
S. typhimurium TA 1538 hisD3052 rfa uvrB
S. typhimurium TA 98 hisD3052 rfa uvrB pKM 10 1
S. typhimun'um TA 100 hisG46 rfa uvrB pKM101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500 and 5000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: As the test substance was a mixture of solids dissolved in water the solvent chosen for this assay was
water which was confirmed in a solubility test.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see below
- Details on test system and experimental conditions:
- Positive control substances:
without S9 mix:
Identity: N-Ethyl-N'-nitro-N-nitrosoguanidine
Supplier: Sigma
Batch: 67F-3700
Solvent: DMSO
Concentration: 5 microgram/plate for strain TA 1535
3 microgram/plate for strain TA 100
Identity: 9-Aminoacridine
Supplier: Sigma
Batch: 96F-05641
Solvent: DMSO
Concentration: 80 microgram/plate for strain TA 1537
Identity: 2-Aminoanthracene
Supplier: Aldrich
Batch: 61896
Solvent: DMSO
Concentration: 2 microgram/plate for strain TA 1538
1 microgram/plate for strain TA 98
With S9 mix:
dentity: 2-Aminoanthracene
Supplier: Aldrich
Batch: 0013406
Solvent: DMSO
Concentration: 2 microgram/plate for strain TA 1535 and TA 1537
0.5 microgram/plate for strain TA 1538 and TA 98
1 microgram/plate for strain TA 100
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: 3 days
SELECTION AGENT (mutation assays): histidine defiencient agar
NUMBER OF REPLICATIONS: three petri dishes per dose level and an independent repeat was performed
NUMBER OF CELLS EVALUATED: all colonies were counted
DETERMINATION OF CYTOTOXICITY
- Method: assessment a background lawn
- Evaluation criteria:
- The mean number of revertant colonies for all treatment groups is compared with those obtained for solvent control groups. The mutagenic activity of a test substance is assessed by applying the following criteria:
(a) If treatment with a test substance produces an increase in revertant colony numbers of at least twice the concurrent solvent controls, with some evidence of a positive dose-relationship, in two separate experiments, with any bacterial strain either in the presence or absence of S-9 mix, it is considered to show evidence of mutagenic activity in this test system. No statistical analysis is performed.
(b) If treatment with a test substance does not produce reproducible increases of at least 1.5 times the concurrent solvent controls, at my dose level with any bacterial strain, it is considered to show no evidence of mutagenic activity in this test system. No statistical analysis is performed.
(c) If the results obtained fail to satisfy the criteria for a clear "positive" or "negative" response given in paragraphs (a) and (b), the following approach is taken in order to resolve the issue of the substance's mutagenic activity in this test system.
(i) Repeat tests may be performed using modifications of the experimental method. These modifications include (but are not restricted to), the use of a narrower dose range than that already tested; the use of different levels of liver homogenate S-9 fraction in the S-9 mix. Should an increase in revertant colony numbers be observed which satisfies paragraph (a) the substance is considered to show evidence of mutagenic activity in this .
test system. No statistical analysis is performed.
(ii) If no clear "positive" response can be obtained the test data may be subjected to analysis to determine the statistical significance of any observed increases in revertant colony numbers. The statisticd procedures used will be those described by Mahon et at. (1989). - Statistics:
- Not performed
Results and discussion
Test results
- Species / strain:
- other: all strains tested
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not examined
- Effects of osmolality: not examined
- Evaporation from medium: not examined
- Water solubility: sufficient for the test
- Precipitation: not observed
- Other confounding effects: not examined
RANGE-FINDING/SCREENING STUDIES: No cytotoxicty was observed in the preliminary toxicity test up to 5000 microgram/plate. this dose was therefore also selcted as the highest dose in the final study.
COMPARISON WITH HISTORICAL CONTROL DATA: not performed
No substantial increases in revertant colony numbers of any of the tester strains were observed following treatment with Ampholak 7CX at any dose level, in the presence or absence of S-9 mix, in either mutation test.
The concurrent positive control compounds demonstrated the sensitivity of the assay and the rnehbolising activity of the liver preparations. - 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 |
TA1535 |
5000 |
- |
16 |
3.2 |
1500 |
- |
10 |
2.6 |
|
500 |
- |
10 |
4.2 |
|
150 |
- |
16 |
2.9 |
|
50 |
- |
17 |
2.5 |
|
0 |
- |
13 |
3.2 |
|
solvent |
- |
18 |
2.1 |
|
5000 |
+ |
18 |
2.5 |
|
1500 |
+ |
15 |
2.6 |
|
500 |
+ |
11 |
6.1 |
|
150 |
+ |
16 |
5.7 |
|
50 |
+ |
13 |
2.5 |
|
0 |
+ |
15 |
1.5 |
|
solvent |
+ |
13 |
4.2 |
|
TA1537 |
5000 |
- |
8 |
3.5 |
1500 |
- |
5 |
2.6 |
|
500 |
- |
8 |
4.7 |
|
150 |
- |
11 |
4.0 |
|
50 |
- |
9 |
2.3 |
|
0 |
- |
10 |
2.6 |
|
solvent |
- |
9 |
2.1 |
|
5000 |
+ |
8 |
1.7 |
|
1500 |
+ |
6 |
3.1 |
|
500 |
+ |
7 |
4.2 |
|
150 |
+ |
10 |
5.9 |
|
50 |
+ |
11 |
1.5 |
|
0 |
+ |
14 |
3.5 |
|
solvent |
+ |
10 |
6.1 |
|
TA1538 |
5000 |
- |
9 |
1.5 |
1500 |
- |
7 |
1.2 |
|
500 |
- |
14 |
2.6 |
|
150 |
- |
12 |
4.0 |
|
50 |
- |
13 |
2.1 |
|
0 |
- |
9 |
6.8 |
|
solvent |
- |
12 |
2.3 |
|
5000 |
+ |
14 |
1.2 |
|
1500 |
+ |
12 |
6.7 |
|
500 |
+ |
11 |
1.7 |
|
150 |
+ |
14 |
3.1 |
|
50 |
+ |
11 |
3.1 |
|
0 |
+ |
19 |
3.2 |
|
solvent |
+ |
20 |
2.1 |
|
TA98 |
5000 |
- |
18 |
3.6 |
1500 |
- |
19 |
3.2 |
|
500 |
- |
20 |
1.5 |
|
150 |
- |
23 |
4.4 |
|
50 |
- |
23 |
3.6 |
|
0 |
- |
28 |
2.6 |
|
solvent |
- |
25 |
5.5 |
|
5000 |
+ |
22 |
1.5 |
|
1500 |
+ |
23 |
2.0 |
|
500 |
+ |
28 |
3.8 |
|
150 |
+ |
27 |
2.6 |
|
50 |
+ |
26 |
2.0 |
|
0 |
+ |
29 |
2.5 |
|
solvent |
+ |
26 |
5.6 |
|
TA100 |
5000 |
- |
121 |
7.4 |
1500 |
- |
122 |
17.3 |
|
500 |
- |
103 |
9.3 |
|
150 |
- |
119 |
12.9 |
|
50 |
- |
113 |
5.3 |
|
0 |
- |
113 |
7.4 |
|
solvent |
- |
108 |
4.6 |
|
5000 |
+ |
112 |
13.6 |
|
1500 |
+ |
118 |
9.8 |
|
500 |
+ |
119 |
17.8 |
|
150 |
+ |
106 |
9.6 |
|
50 |
+ |
108 |
6.1 |
|
0 |
+ |
120 |
4.0 |
|
solvent |
+ |
101 |
7.6 |
- Absence
+ Presence
SD Standard deviation
Positive control Mutation test 1:
Strain |
Compound |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
SD |
TA1535 |
ENNG |
5.0 |
- |
223 |
30.9 |
TA1537 |
9 AC |
80.0 |
- |
X |
- |
TA1538 |
NF |
2.0 |
- |
173 |
28.4 |
TA98 |
NF |
1.0 |
- |
260 |
8.9 |
TA100 |
ENNG |
3.0 |
- |
286 |
6.0 |
TA1535 |
AA |
2.0 |
+ |
139 |
20.6 |
TA1537 |
AA |
2.0 |
+ |
77 |
5.9 |
TA1538 |
NF |
0.5 |
+ |
187 |
15.6 |
TA98 |
AA |
0.5 |
+ |
221 |
19.5 |
TA100 |
AA |
1.0 |
+ |
473 |
72.4 |
- Absence
+ Presence
X Too many colonies to count accurately
SD Standard deviation
ENNG N-ethyl-N’-nitro-N-nitrosoguanidine
9AC 9-aminoacridine
NF 2-nitrofluorene
AA 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
It is concluded that, when tested in water, the test material (40% active ingredient and 60% water) was not mutagenic in this bacterial system. 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. Under the given conditions, the active ingredient Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) is considered to be non mutagenic. - Executive summary:
In this in vitro assessment of the mutagenic potential of the test material, histidine dependent auxotrophic mutanrs of Salmonella typhimunum (strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100) were exposed to the test substance, diluted in water which was also used as a negative control. Two independent mutation tests were performed accoriding to OECD guodlien and under GLP, in the presence and absence of liver preparations from Aroclor 1254-induced rats. In the preliminary dose range finding study with dose levels of up to 5000 μg/plate no toxicity was observed. A top dose level of 5000 μg/plate was chosen for the subsequent mutation study. Other dose levels used in the mutation assays were: 1500, 500, 150, 50 μg/plate. No evidence of mutagenic activity was seen at any dose level of the test material in either mutation test. The concurrent positive control compounds demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. It is concluded that, when tested in water, the test materal was not mutagenic in this bacterial system. Under the given conditions, the active ingredient Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) is therefore considered to be non mutagenic. 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.
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