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EC number: 240-166-3 | CAS number: 16026-16-7
- 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
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- Oxidation reduction potential
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- Storage stability and reactivity towards container material
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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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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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No data on genetic toxicity is available for the substancecalcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate]. Read across fromsodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetateis used to complete the in vitro gene mutation in bacteria endpoint.
Negative result was obtained in the key in vitro bacterial reverse mutation assay (Ames test) according to the OECD 471 guideline conducted with the read across substance, sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate.
Link to relevant study records
- 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:
- 22 Aug 2012 - 24 Oct 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions. Test dilution was membrane filtrated.
- Justification for type of information:
- Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross reference'.
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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 (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Rheinland-Pfalz, Mainz, Germany
- Type of assay:
- bacterial forward mutation assay
- Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102, TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- First experiment: 50, 150, 500, 1501 and 5004 µg/plate with and without metabolic activation
Second experiment:313, 625, 1251, 2501 and 5002 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: the test item was completely soluble in water. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine (NPD ; 20 µg/plate, -S9, TA98, TA97a and TA102); sodium azide (1 µg/plate, -S9, TA100 and TA1535), benzo-a-pyrene (BaP; 20 µg/plate, +S9, TA98), 2-Amino-anthracene (2-AA; 1 µg/plate, +S9, TA97a, TA100, TA102 and TA1535 )
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, first experiment); preincubation (second experiment)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 4 replications each in one independent experiment
DETERMINATION OF CYTOTOXICITY
- Method: titre determination; the titre was determined by dilution of the overnight culture using sodium chloride solution and placing 0.1 mL on maximal-soft agar. Incubation over night at 37°C followed. The titre control should reach a concentration of at least 10E9 cells/mL. - Evaluation criteria:
- The test material may be considered as mutagen if a significant, reproducible increase of revertant colonies per plate (increase factorI ≥ 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
- Statistics:
- Mean values and standard deviation were calculated.
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: The historical data of the spontaneous revertants and positive controls with the above described rains are stated in comparison with the experiments performed within this study.Only marginal differences were observed within the study.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative - Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 22 Aug 2012 - 24 Oct 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions. Test dilution was membrane filtrated.
- Justification for type of information:
- Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross reference'.
- Reason / purpose for cross-reference:
- read-across source
- 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 (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Rheinland-Pfalz, Mainz, Germany
- Type of assay:
- bacterial forward mutation assay
- Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102, TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- First experiment: 50, 150, 500, 1501 and 5004 µg/plate with and without metabolic activation
Second experiment:313, 625, 1251, 2501 and 5002 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: the test item was completely soluble in water. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine (NPD ; 20 µg/plate, -S9, TA98, TA97a and TA102); sodium azide (1 µg/plate, -S9, TA100 and TA1535), benzo-a-pyrene (BaP; 20 µg/plate, +S9, TA98), 2-Amino-anthracene (2-AA; 1 µg/plate, +S9, TA97a, TA100, TA102 and TA1535 )
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, first experiment); preincubation (second experiment)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 4 replications each in one independent experiment
DETERMINATION OF CYTOTOXICITY
- Method: titre determination; the titre was determined by dilution of the overnight culture using sodium chloride solution and placing 0.1 mL on maximal-soft agar. Incubation over night at 37°C followed. The titre control should reach a concentration of at least 10E9 cells/mL. - Evaluation criteria:
- The test material may be considered as mutagen if a significant, reproducible increase of revertant colonies per plate (increase factorI ≥ 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
- Statistics:
- Mean values and standard deviation were calculated.
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: The historical data of the spontaneous revertants and positive controls with the above described rains are stated in comparison with the experiments performed within this study.Only marginal differences were observed within the study.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Referenceopen allclose all
Table 1. Test results of experiment 1 (plate incorporation).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 4 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
TA102 |
TA98 |
TA97a |
||
|
Water |
88 ± 8.4 |
15 ± 3.3 |
148 ± 21.6 |
16 ± 2.2 |
108 ± 5.7 |
– |
DMSO |
83 ± 7 |
15 ± 3.7 |
116 ± 8.5 |
20 ± 1.3 |
104 ± 7.9 |
– |
50 |
88 ± 20 |
20 ± 1 |
135 ± 6 |
15 ± 1 |
115 ± 1 |
– |
150 |
81 ± 17 |
19 ± 4 |
133 ± 8 |
13 ± 3 |
119 ± 4 |
– |
500 |
81 ± 11 |
20 ± 1 |
152 ± 15 |
17 ± 2 |
111 ± 3 |
– |
1501 |
71 ± 7 |
18 ± 3 |
145 ± 7 |
13 ± 2 |
113 ± 2 |
– |
5004 |
73 ± 9 |
18 ± 2 |
140 ± 12 |
15 ± 3 |
113 ± 3 |
Positive controls, –S9 |
Name |
SA |
SA |
4NPD |
4NPD |
4NPD |
Concentrations (μg/plate) |
1 |
1 |
20 |
20 |
20 |
|
Mean No. of colonies/plate (average of 4 ± SD) |
570 ± 38 |
203 ± 9 |
613 ± 16 |
195 ± 7 |
476 ± 27 |
|
+ |
Water |
96 ± 14.5 |
19 ± 1.4 |
123 ± 9.1 |
17 ± 1.6 |
111 ± 5.7 |
+ |
DMSO |
75 ± 8.6 |
17 ± 2.4 |
135 ± 5.4 |
16 ± 1.5 |
109 ± 2.9 |
+ |
50 |
93 ± 13 |
18 ± 1 |
127 ± 5 |
16 ± 1 |
109 ± 6 |
+ |
150 |
90 ± 5 |
20 ± 1 |
153 ± 12 |
15 ± 2 |
102 ± 5 |
+ |
500 |
91 ± 6 |
18 ± 3 |
132 ± 8 |
15 ± 2 |
107 ± 3 |
+ |
1500 |
85 ± 8 |
17 ± 2 |
140 ± 8 |
13 ± 2 |
105 ± 2 |
+ |
5004 |
94 ± 6 |
16 ± 2 |
128 ± 12 |
14 ± 3 |
115 ± 6 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
1 |
1 |
1 |
20 |
1 |
|
Mean No. of colonies/plate (average of 4 ± SD) |
487 ± 42 |
213 ± 15 |
586 ± 106 |
193 ± 11 |
573 ± 43 |
4NPD = 4-Nitro-1,2-phenylendiamin
2AA = 2-Aminoanthracene
BP = Benzo(a)pyrene
Table 2. Test restults of experiment 2 (pre incubation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 4 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
TA102 |
TA98 |
TA97a |
||
|
Water |
114 ± 91 |
16 ± 6,7 |
97 ± 15,7 |
15 ± 3,9 |
104 ± 5,8 |
– |
DMSO |
94 ± 14,5 |
14 ± 6,2 |
106 ± 19,6 |
18,8,5 |
95 ± 10,3 |
– |
313 |
90 ± 18 |
9 ± 3 |
112 ± 27 |
14 ± 5 |
112 ± 28 |
– |
626 |
80 ± 24 |
25 ± 4 |
99 ± 27 |
20 ± 10 |
107 ± 8 |
– |
1251 |
105 ± 42 |
18 ± 6 |
105 ± 42 |
18 ± 5 |
113 ± 11 |
– |
2501 |
99 ± 27 |
12,4 |
97 ± 13 |
20 ± 11 |
115 ± 21 |
– |
5002 |
94 ± 24 |
16 ± 7 |
107 ± 321 |
16 ± 5 |
126 ± 26 |
Positive controls, –S9 |
Name |
SA |
SA |
4NPD |
4NPD |
4NPD |
Concentrations (μg/plate) |
1 |
1 |
20 |
20 |
20 |
|
Mean No, of colonies/plate (average of 4 ± SD) |
522 ± 34 |
212 ± 23 |
576 ± 53 |
195 ± 13 |
440 ± 32 |
|
+ |
Water |
98 ± 20,9 |
15 ± 7,8 |
96 ± 26,1 |
18 ± 9,3 |
109 ± 5,4 |
+ |
DMSO |
100 ± 24,3 |
21 ± 7,1 |
109 ± 32,7 |
20 ± 6,8 |
103 ± 7,0 |
+ |
313 |
90 ± 7 |
20 ± 9 |
72 ± 39 |
17 ± 4 |
96 ± 12 |
+ |
626 |
97 ± 26 |
30 ± 7 |
96 ± 13 |
15 ± 7 |
113 ± 5 |
+ |
1251 |
83 ± 31 |
20 ± 10 |
81 ± 25 |
22 ± 6 |
115 ± 13 |
+ |
1500 |
90 ± 25 |
28 ± 7 |
101 ± 26 |
13 ± 3 |
119 ± 13 |
+ |
5004 |
97 ± 24 |
21 ± 10 |
97 ± 21 |
23 ± 7 |
118 ± 13 |
Positive controls, + S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
1 |
1 |
1 |
20 |
1 |
|
Mean No, of colonies/plate (average of 4 ± SD) |
462 ± 57 |
218 ± 14 |
533 ± 100 |
201 ± 33 |
512 ± 39 |
4NPD = 4-Nitro-1,2-phenylendiamin
2AA = 2-Aminoanthracene
BP = Benzo(a)pyrene
Table 1. Test results of experiment 1 (plate incorporation).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 4 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
TA102 |
TA98 |
TA97a |
||
|
Water |
88 ± 8.4 |
15 ± 3.3 |
148 ± 21.6 |
16 ± 2.2 |
108 ± 5.7 |
– |
DMSO |
83 ± 7 |
15 ± 3.7 |
116 ± 8.5 |
20 ± 1.3 |
104 ± 7.9 |
– |
50 |
88 ± 20 |
20 ± 1 |
135 ± 6 |
15 ± 1 |
115 ± 1 |
– |
150 |
81 ± 17 |
19 ± 4 |
133 ± 8 |
13 ± 3 |
119 ± 4 |
– |
500 |
81 ± 11 |
20 ± 1 |
152 ± 15 |
17 ± 2 |
111 ± 3 |
– |
1501 |
71 ± 7 |
18 ± 3 |
145 ± 7 |
13 ± 2 |
113 ± 2 |
– |
5004 |
73 ± 9 |
18 ± 2 |
140 ± 12 |
15 ± 3 |
113 ± 3 |
Positive controls, –S9 |
Name |
SA |
SA |
4NPD |
4NPD |
4NPD |
Concentrations (μg/plate) |
1 |
1 |
20 |
20 |
20 |
|
Mean No. of colonies/plate (average of 4 ± SD) |
570 ± 38 |
203 ± 9 |
613 ± 16 |
195 ± 7 |
476 ± 27 |
|
+ |
Water |
96 ± 14.5 |
19 ± 1.4 |
123 ± 9.1 |
17 ± 1.6 |
111 ± 5.7 |
+ |
DMSO |
75 ± 8.6 |
17 ± 2.4 |
135 ± 5.4 |
16 ± 1.5 |
109 ± 2.9 |
+ |
50 |
93 ± 13 |
18 ± 1 |
127 ± 5 |
16 ± 1 |
109 ± 6 |
+ |
150 |
90 ± 5 |
20 ± 1 |
153 ± 12 |
15 ± 2 |
102 ± 5 |
+ |
500 |
91 ± 6 |
18 ± 3 |
132 ± 8 |
15 ± 2 |
107 ± 3 |
+ |
1500 |
85 ± 8 |
17 ± 2 |
140 ± 8 |
13 ± 2 |
105 ± 2 |
+ |
5004 |
94 ± 6 |
16 ± 2 |
128 ± 12 |
14 ± 3 |
115 ± 6 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
1 |
1 |
1 |
20 |
1 |
|
Mean No. of colonies/plate (average of 4 ± SD) |
487 ± 42 |
213 ± 15 |
586 ± 106 |
193 ± 11 |
573 ± 43 |
4NPD = 4-Nitro-1,2-phenylendiamin
2AA = 2-Aminoanthracene
BP = Benzo(a)pyrene
Table 2. Test restults of experiment 2 (pre incubation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 4 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
TA102 |
TA98 |
TA97a |
||
|
Water |
114 ± 91 |
16 ± 6,7 |
97 ± 15,7 |
15 ± 3,9 |
104 ± 5,8 |
– |
DMSO |
94 ± 14,5 |
14 ± 6,2 |
106 ± 19,6 |
18,8,5 |
95 ± 10,3 |
– |
313 |
90 ± 18 |
9 ± 3 |
112 ± 27 |
14 ± 5 |
112 ± 28 |
– |
626 |
80 ± 24 |
25 ± 4 |
99 ± 27 |
20 ± 10 |
107 ± 8 |
– |
1251 |
105 ± 42 |
18 ± 6 |
105 ± 42 |
18 ± 5 |
113 ± 11 |
– |
2501 |
99 ± 27 |
12,4 |
97 ± 13 |
20 ± 11 |
115 ± 21 |
– |
5002 |
94 ± 24 |
16 ± 7 |
107 ± 321 |
16 ± 5 |
126 ± 26 |
Positive controls, –S9 |
Name |
SA |
SA |
4NPD |
4NPD |
4NPD |
Concentrations (μg/plate) |
1 |
1 |
20 |
20 |
20 |
|
Mean No, of colonies/plate (average of 4 ± SD) |
522 ± 34 |
212 ± 23 |
576 ± 53 |
195 ± 13 |
440 ± 32 |
|
+ |
Water |
98 ± 20,9 |
15 ± 7,8 |
96 ± 26,1 |
18 ± 9,3 |
109 ± 5,4 |
+ |
DMSO |
100 ± 24,3 |
21 ± 7,1 |
109 ± 32,7 |
20 ± 6,8 |
103 ± 7,0 |
+ |
313 |
90 ± 7 |
20 ± 9 |
72 ± 39 |
17 ± 4 |
96 ± 12 |
+ |
626 |
97 ± 26 |
30 ± 7 |
96 ± 13 |
15 ± 7 |
113 ± 5 |
+ |
1251 |
83 ± 31 |
20 ± 10 |
81 ± 25 |
22 ± 6 |
115 ± 13 |
+ |
1500 |
90 ± 25 |
28 ± 7 |
101 ± 26 |
13 ± 3 |
119 ± 13 |
+ |
5004 |
97 ± 24 |
21 ± 10 |
97 ± 21 |
23 ± 7 |
118 ± 13 |
Positive controls, + S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
1 |
1 |
1 |
20 |
1 |
|
Mean No, of colonies/plate (average of 4 ± SD) |
462 ± 57 |
218 ± 14 |
533 ± 100 |
201 ± 33 |
512 ± 39 |
4NPD = 4-Nitro-1,2-phenylendiamin
2AA = 2-Aminoanthracene
BP = Benzo(a)pyrene
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The bacterial reverse mutation assay (Ames test) with read across substance, sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate, was conducted according to the OECD guideline 471 (LAUS 2012). No increase in revertant colonies was observed, either in the presence or absence of S9 metabolic activation system, and the test substance was considered to be non-mutagenic under the conditions of the OECD study.
Therefore, no classification is considered relevant for this endpoint for calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate].
The study is GLP-compliant, guideline study, and has been assigned a Klimisch score of 1.
Justification for classification or non-classification
Negative result was observed in an in vitro reverse mutation test in bacterial cells with read across substance, sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate.
Therefore, no classification is considered relevant for this endpoint for calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate].
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