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EC number: 240-166-3 | CAS number: 16026-16-7
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].
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
