Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 940-123-5 | CAS number: 866889-74-9
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012-08-15 to 2012-10-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- (31 May 2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- (adopted July 21, 1997)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 7651-02-7 (Stearic acid 3-(dimethylaminopropyl)amide)
- IUPAC Name:
- 7651-02-7 (Stearic acid 3-(dimethylaminopropyl)amide)
- Details on test material:
- - Chemical name: Stearic acid 3-(dimethylaminopropyl)amide
Constituent 1
Method
- Target gene:
- thymidine kinase
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
Horse serum: inactivated by incubation at 56°C for at least 30 minutes.
Basic medium: RPMI 1640 Hepes buffered medium (Dutch modification) containing penicillin/streptomycin (50 U/mL and 50 μg/mL, respectively), 1 mM sodium pyruvate and 2 mM L-glutamin
Growth medium: Basic medium, supplemented with 10% (v/v) heat-inactivated horse serum (=R10 medium).
Exposure medium
For 3 hour exposure: basic medium supplemented with 5% (v/v) heat-inactivated horse serum (R5-medium).
For 24 hour exposure: basic medium supplemented with 10% (v/v) heat-inactivated horse serum (R10-medium).
Selective medium: basic medium supplemented with 20% (v/v) heat-inactivated horse serum (total amount of serum = 20%, R20) and 5 μg/mL trifluorothymidine (TFT)
Non-selective medium: basic medium supplemented with 20% (v/v) heat-inactivated horse serum (total amount of serum = 20%, R20)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no information given
- Periodically "cleansed" against high spontaneous background: yes, prior to experiment - Additional strain / cell type characteristics:
- other: thymidine kinase deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment 1
Without S9-mix: 0.003, 0.01, 0.03, 0.1, 0.3, 0.6, 1, 2.5, 5, 7.5 and 10 μg/mL exposure medium.
With 8% (v/v) S9-mix: 0.1, 0.6, 1, 5, 10, 20, 30, 40, 50, 60, 70 and 85 μg/mL exposure medium.
Experiment 2
Without S9-mix: 0.01, 0.03, 0.1, 0.3, 0.6, 1, 3, 4, 5, 6.5 and 7.5 μg/mL exposure medium.
With 12% (v/v) S9-mix: 0.1, 0.3, 1, 3, 10, 20, 30, 40, 50 and 60 μg/mL exposure medium.
The dose levels selected to measure mutation frequencies at the TK-locus were:
Experiment 1:
Without S9-mix: 0.003, 0.01, 0.03, 0.1, 0.3, 1, 2.5 and 5 μg/mL exposure medium.
With S9-mix: 0.1, 0.6, 1, 5, 10, 20, 30 and 40 μg/mL exposure medium.
Experiment 2:
Without S9-mix: 0.01, 0.03, 0.1, 0.3, 0.6, 1 and 3 μg/mL exposure medium.
With S9-mix: 0.1, 1, 3, 10, 30, 40, 50 and 60 μg/mL exposure medium. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol, final concentration of the solvent in the exposure medium was 0.4% (v/v)
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- Positive controls:
- yes
- Remarks:
- 15 µg/mL (3 h) and 5 μg/mL (24 h)
- Positive control substance:
- methylmethanesulfonate
- other: (without metabolic activation)
- Positive controls:
- yes
- Remarks:
- 10 μg/mL
- Positive control substance:
- cyclophosphamide
- other: (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 h / 24 h (without metabolic activation); 3 h with 8 or 12 % S9 mix
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 11 (cloning efficiency) or 12 days (mutant frequency)
- Fixation time (start of exposure up to fixation or harvest of cells): 15 days
SELECTION AGENT (mutation assays): 5 μg/mL trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: 2 independent experiments, 1 replicate each
NUMBER OF CELLS EVALUATED:
8E06 cells (1E06 cells/mL) for 3 hours treatment, 5E06 cells (1.25E05 cells/mL) for 24 hours treatment
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A mutation assay was considered acceptable if it met the following criteria:
a) The absolute cloning efficiency of the solvent controls (CEday2) is between 65 and 120%. An acceptable number of surviving cells (1E06) could be analysed for expression of the TK mutation.
b) The spontaneous mutation frequency in the solvent control is ≥ 50 per 1E06 survivors and ≤ 170 per 1E06 survivors.
c) The growth rate (GR) over the 2-day expression period for the negative controls should be between 8 and 32 (3 hours treatment) and between 32-180 (24 hours treatment).
d) The mutation frequency of MMS should not be below 500 per 1E06 survivors, and for CP not below 700 per 1E06 survivors.
In addition to the criteria stated below, any increase of the mutation frequency should be evaluated for its biological relevance including a comparison of the results with the historical control data range.
The global evaluation factor (GEF) has been defined by the IWGT as the mean of the negative/solvent MF distribution plus one standard deviation. For the micro well version of the assay the GEF is 126.
A test substance is considered positive (mutagenic) in the mutation assay if it induces a MF of more than MF(controls) + 126 in a dose-dependent manner. An observed increase should be biologically relevant and will be compared with the historical control data range.
A test substance is considered equivocal (questionable) in the mutation assay if no clear conclusion for positive or negative result can be made after an additional confirmation study.
A test substance is considered negative (not mutagenic) in the mutation assay if:
a) None of the tested concentrations reaches a mutation frequency of MF(controls) + 126.
b) The results are confirmed in an independently repeated test.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without S9 mix > 4 µg/mL, with S9 > 50 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- precipitation in the exposure medium at concentrations of 100 μg/mL and above.
The test substance was tested beyond the limit of the solubility to obtain adequate cytotoxicity data, the concentration used as the highest test substance concentration for the dose range finding test was 1000 μg/mL.
RANGE-FINDING/SCREENING STUDIES:
After the 3 hours treatment, severe precipitate of the test substance was observed in the exposure medium at the highest dose levels of 333 and 1000 μg/mL. Therefore, no cell count was possible at these dose levels. In the absence of S9-mix, hardly any or no cell survival was observed at all test substance concentrations tested. In the presence of S9-mix, the relative suspension growth was 39% at the test substance concentration of 33 μg/mL compared to the relative suspension growth of the solvent control. Hardly any or no cell survival was observed at test substance concentrations of 100 μg/mL and above.
COMPARISON WITH HISTORICAL CONTROL DATA:
The spontaneous mutation frequencies in the solvent-treated control cultures were between the minimum and maximum value of the historical control data range except in the absence of S9-mix, in which the mutation frequency of the solvent control cultures were just below the historical control data range.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
First mutagenicity test:
In the presence of S9-mix, the dose levels of 50 to 85 μg/mL were not used for mutation frequency measurement, since these dose levels were too toxic for further testing. The relative total growth of the highest test substance concentration was reduced by 84% compared to the total growth of the solvent controls in the absence and presence of S9-mix.
Second mutagenicity test:
In the absence of S9-mix, the dose levels of 4 to 7.5 μg/mL were not used for mutation frequency measurement, since these dose levels were too toxic for further testing. In the absence of S9-mix, the relative total growth of the highest test substance was reduced by 81% compared to the total growth of the solvent controls. In the presence of S9-mix, the relative total growth of the highest test substance concentration was reduced by 60% compared to the total growth of the solvent controls.
Any other information on results incl. tables
Experiment 1: |
|||||||
|
Mutation frequency per 1E06 survivors |
||||||
Dose (µg/mL) |
RSG (%) |
CE day 2 (%) |
RS day 2 (%) |
RTG |
Total |
small |
large |
Without metabolic activation |
|||||||
SC1 |
100 |
131 |
100 |
100 |
48 |
15 |
32 |
SC2 |
123 |
48 |
16 |
32 |
|||
0.003 |
101 |
93 |
73 |
74 |
61 |
23 |
36 |
0.01 |
110 |
101 |
79 |
87 |
64 |
19 |
43 |
0.03 |
119 |
118 |
93 |
110 |
59 |
22 |
35 |
0.1 |
118 |
95 |
75 |
89 |
58 |
22 |
34 |
0.3 |
114 |
104 |
82 |
93 |
51 |
19 |
30 |
1 |
89 |
135 |
106 |
95 |
48 |
15 |
31 |
2.5 |
74 |
78 |
61 |
45 |
84 |
33 |
49 |
5 |
23 |
88 |
69 |
16 |
56 |
28 |
27 |
MMS |
80 |
51 |
40 |
32 |
840 |
192 |
578 |
With 8% (v/v) metabolic activation |
|||||||
SC1 |
100 |
104 |
100 |
100 |
82 |
22 |
57 |
SC2 |
95 |
85 |
23 |
59 |
|||
0.1 |
94 |
94 |
94 |
89 |
89 |
26 |
60 |
0.6 |
97 |
110 |
110 |
108 |
74 |
24 |
47 |
1 |
102 |
83 |
83 |
85 |
97 |
34 |
60 |
5 |
47 |
95 |
96 |
45 |
88 |
42 |
42 |
10 |
79 |
74 |
74 |
59 |
119 |
42 |
72 |
20 |
57 |
104 |
104 |
59 |
69 |
30 |
36 |
30 |
44 |
86 |
87 |
38 |
101 |
26 |
72 |
40 |
19 |
84 |
84 |
16 |
107 |
32 |
71 |
CP |
52 |
44 |
44 |
23 |
1502 |
395 |
892 |
Experiment 2: |
|||||||
|
Mutation frequency per 1E06 survivors |
||||||
Dose (µg/ml) |
RSG (%) |
CE day 2 (%) |
RS day 2 (%) |
RTG |
Total |
small |
large |
Without metabolic activation |
|||||||
SC1 |
100 |
95 |
100 |
100 |
59 |
33 |
25 |
0.01 |
108 |
88 |
93 |
100 |
55 |
38 |
16 |
0.03 |
103 |
102 |
107 |
110 |
68 |
40 |
25 |
0.1 |
96 |
93 |
98 |
94 |
72 |
43 |
26 |
0.3 |
89 |
115 |
121 |
107 |
48 |
24 |
22 |
0.6 |
105 |
95 |
100 |
105 |
69 |
17 |
50 |
1 |
97 |
101 |
106 |
103 |
69 |
23 |
43 |
3 |
21 |
89 |
94 |
19 |
74 |
23 |
49 |
MMS |
100 |
88 |
93 |
93 |
527 |
197 |
271 |
With 12% (v/v) metabolic activation |
|||||||
SC1 |
100 |
95 |
100 |
100 |
92 |
48 |
40 |
SC2 |
78 |
104 |
72 |
29 |
|||
0.1 |
101 |
86 |
100 |
101 |
90 |
64 |
23 |
1 |
101 |
85 |
98 |
99 |
57 |
34 |
21 |
3 |
109 |
120 |
138 |
151 |
46 |
32 |
13 |
10 |
102 |
84 |
97 |
99 |
125 |
64 |
55 |
30 |
78 |
93 |
107 |
83 |
98 |
44 |
49 |
40 |
77 |
97 |
112 |
86 |
67 |
31 |
33 |
50 |
56 |
85 |
98 |
55 |
130 |
55 |
67 |
60 |
31 |
111 |
129 |
40 |
90 |
51 |
34 |
CP |
58 |
50 |
58 |
34 |
1056 |
430 |
487 |
Note: all calculations were made without
rounding off
RSG = Relative Suspension Growth; CE = Cloning Efficiency; RS = Relative
Survival; RTG = Relative Total Growth; SC = Solvent control = ethanol;
MMS = Methylmethanesulfonate; CP = Cyclophosphamide
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
It is concluded that Stearic acid 3-(dimethylaminopropyl)amide is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions described in this report. - Executive summary:
In a mammalian cell gene mutation assay according to OECD guideline 467, adopted July 21, 1997 (thymidine kinase (TK)), L5178Y mouse lymphoma cells cultured in vitro were exposed to Stearic acid 3-(dimethylaminopropyl)amide (100% purity) in ethanol in the following concentrations in the presence and absence of mammalian metabolic activation (S9 mix):
First experiment
Without S9-mix, 3 h treatment: 0.003, 0.01, 0.03, 0.1, 0.3, 1, 2.5 and 5 μg/mL
With 8% S9-mix, 3 h treatment: 0.1, 0.6, 1, 5, 10, 20, 30 and 40 μg/mL
Second experiment
Without S9-mix, 3 h treatment: 0.01, 0.03, 0.1, 0.3, 0.6, 1 and 3 μg/mL
With 12% S9-mix, 24 h treatment: 0.1, 1, 3, 10, 30, 40, 50 and 60 μg/mL
Stearic acid 3-(dimethylaminopropyl)amide was tested up to cyctotoxic concentrations.The positive controls induced the appropriate response.There was no evidence of induced mutant colonies over background.
This study is classified as acceptable and satisfies the requirement for Test Guideline OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data.
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.