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EC number: 271-685-3 | CAS number: 68604-33-1 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid ammonium salt and SDA Reporting Number: 04-006-01.
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames tests:
The structural analogue substance 9-octadecenoic acid was not mutagenic in a bacterial reverse mutation assay.
The structural analogue substance Octadecanoic acid was not mutagenic in a bacterial reverse mutation assay.
The structural analogue substance (cations) Ammonia was not mutagenic in a bacterial reverse mutation assay.
Based on the structural similarity of the target substance to the analogue substances, the read across study for genetic toxicity in vitro on chemically similar substance (Ames test: bacterial reverse mutation assay) and the weight of evidence approach, the target substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for mutagenicity (Based on available data, the classification criteria are not met.).
Link to relevant study records
- 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:
- weight of evidence
- Justification for type of information:
- Read-across justification / weight of evidence justification:
The target substance Fatty acids, C14-18 and C16-18-unsatd., ammonium salts consists of ammonium salts of the fatty acids Myristic Acid (C14 ), Palmitic acid (C16), Stearic acid (C18), Palmitoleic acid (C16:1), Oleic acid (C18:1), Linoleic acid (C18:2) and Linolenic acid (C18:3).
Information on genetic toxicity in vitro (Ames test: bacterial reverse mutation assay) of Oleic Acid (as representative of the unsaturated fatty acids and main constituent of fatty acids), Stearic acid (as representative of the saturated fatty acids) and Ammonia (as representative of the ammonium cation) is available. As results, this structural analogue substances were not mutagenic in a bacterial reverse mutation assay.
Therefore and based on the structural similarity of the target substance to the analogue substances, the results of the genetic toxicity in vitro of the source substances can be assigned to the target substance.
Based on these available data on genetic toxicity in vitro, the target substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for mutagenicity. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- other: S. typhimurium TA98, TA100, TA1535, TA1537, TA1538, E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- growth inhibiton was observed in strains T 1537 and TA 1538 treated with 10, 50 and 100 µg of the analogue substance/plate without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA98, TA100, TA1535, TA1537, TA1538, E. coli WP2 uvrA
- 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. Migrated from field 'Test system'.
- Remarks:
- Result of octadec-9-enoic acid.
- Conclusions:
- Based on read across study for genetic toxicity in vitro on chemically similar substance (Ames test: bacterial reverse mutation assay) and GHS criteria, the target substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for mutagenicity (Based on available data, the classification criteria are not met.).
Based on read across study for genetic toxicity in vitro on chemically similar substance (Ames test: bacterial reverse mutation assay) and upon the DSD classification criteria (67/548/EEC), the target substance is not considered to be classified for mutagenicity (Based on available data, the classification criteria are not met.). - Executive summary:
Ames tests:
The structural analogue substance 9-octadecenoic acid was not mutagenic in a bacterial reverse mutation assay.
The structural analogue substance Octadecanoic acid was not mutagenic in a bacterial reverse mutation assay.
The structural analogue substance (cations) Ammonia was not mutagenic in a bacterial reverse mutation assay.
- 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
- Justification for type of information:
- Read-across (analogue): For justification of read-across see section 13.2.
- Reason / purpose for cross-reference:
- read-across source
- 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:
- cytotoxicity
- Remarks:
- slight toxicity observed at the highest dose group
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Result of octadec-9-enoic acid.
- Conclusions:
- Based on read across study for genetic toxicity in vitro on chemically similar substance and GHS criteria, the target substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for mutagenicity (Based on available data, the classification criteria are not met.).
- Executive summary:
Ames test: The structural analogue substance 9 -octadecenoic acid was not mutagenic in a bacterial reverse mutation assay.
- 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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study summary, acceptable for assessment with restrictions, no study available for review, only four strains tested.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- induced male Sprague Dawley rat liver S9 and induced male Syrian hamster liver S9
- Test concentrations with justification for top dose:
- 0.1, 0.3, 1, 3.3, 10, 33, 100, 333 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
- 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:
- cytotoxicity
- Remarks:
- slight toxicity observed at the highest dose group
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Ames test: The substance 9-octadecenoic acid was not mutagenic in a bacterial reverse mutation assay.
Referenceopen allclose all
Table 1: Results of the genetic toxicity study with oleic acid on Salmonella typhimurium strain TA100
Dose [µg/plate] |
No activation |
No activation |
10 % RLI |
10 % RLI |
10 % HLI |
10 % HLI |
0.1 |
147 |
105 |
|
|
|
|
0.3 |
126 |
98 |
|
|
|
|
1 |
132 |
98 |
|
|
|
|
3.3 |
142* |
87* |
128 |
106 |
143 |
102 |
10 |
115* |
73* |
136 |
116 |
136 |
108 |
33 |
|
|
133 |
115 |
133 |
100 |
100 |
|
|
141 |
102 |
133 |
92 |
333 |
|
|
117* |
86* |
127* |
86* |
Vehicle control |
143 |
98 |
135 |
117 |
142 |
109 |
Positive control |
1138 |
1060 |
895 |
774 |
1340 |
1082 |
*Slight toxicity observed
Table 2: Results of the genetic toxicity study with oleic acid on Salmonella typhimurium strain TA1535
Dose [µg/plate] |
No activation |
No activation |
10 % RLI |
10 % RLI |
10 % HLI |
10 % HLI |
0.1 |
20 |
17 |
|
|
|
|
0.3 |
25 |
15 |
|
|
|
|
1 |
23 |
14 |
|
|
|
|
3.3 |
22* |
11* |
13 |
16 |
10 |
11 |
10 |
18* |
12* |
14 |
8 |
11 |
11 |
33 |
|
|
11 |
11 |
13 |
13 |
100 |
|
|
11 |
11 |
10 |
10 |
333 |
|
|
9* |
8* |
7* |
8* |
Vehicle control |
24 |
20 |
13 |
8 |
12 |
10 |
Positive control |
894 |
760 |
64 |
72 |
84 |
76 |
*Slight toxicity observed
Table 3: Results of the genetic toxicity study with oleic acid on Salmonella typhimurium strain TA1537
Dose [µg/plate] |
No activation |
No activation |
10 % RLI |
10 % RLI |
10 % HLI |
10 % HLI |
0.1 |
7 |
7 |
|
|
|
|
0.3 |
5 |
4 |
|
|
|
|
1 |
6 |
4 |
|
|
|
|
3.3 |
5 |
4 |
5 |
3 |
6 |
5 |
10 |
4* |
5* |
6 |
5 |
6 |
5 |
33 |
|
|
6 |
6 |
7 |
7 |
100 |
|
|
7 |
5 |
5 |
6 |
333 |
|
|
7* |
4* |
6* |
6* |
Vehicle control |
4 |
6 |
7 |
4 |
5 |
10 |
Positive control |
326 |
223 |
59 |
49 |
92 |
81 |
*slight toxicity observed
Table 4: Results of the genetic toxicity study with oleic acid on Salmonella typhimurium strain TA98
Dose [µg/plate] |
No activation |
No activation |
10 % RLI |
10 % RLI |
10 % HLI |
10 % HLI |
0.1 |
16 |
14 |
|
|
|
|
0.3 |
14 |
15 |
|
|
|
|
1 |
13 |
14 |
|
|
|
|
3.3 |
15 |
14 |
24 |
19 |
23 |
18 |
10 |
16 |
13 |
32 |
23 |
26 |
24 |
33 |
|
|
25 |
29 |
23 |
26 |
100 |
|
|
31 |
20 |
26 |
30 |
333 |
|
|
23* |
24 |
29 |
25 |
Vehicle control |
18 |
15 |
26 |
16 |
20 |
24 |
Positive control |
1319 |
1263 |
386 |
792 |
819 |
1169 |
*slight toxicity observed
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
No adequate animal data are available and no epidemiological studies investigating the genotoxicity (in vitro) of the test (target) substance were identified. However, data from a structural analogue (read across substance) are available.
The read across substance 9-octadecenoic acid (Oleic acid, CAS 112-80-1) was tested in a bacterial reverse mutation assay using 4 Salmonella typhimurium strains: strain TA98, TA100, TA1535 and TA1537. The substance was tested in the following concentrations: 0.1, 0.3, 1, 3.3, 10, 33, 100, 333 µg/plate. Besides that, the vehicle (DMSO) and a positive control were included in the test for each strain. The read across substance was tested without and with metabolic activation (induced male Sprague Dawley rat liver S9 and induced male Syrian hamster liver S9). The test results gave no indication for a mutagenic property of the tested substance in the bacterial reverse mutation assay.
Information on genetic toxicity in vitro (Ames test: bacterial reverse mutation assay) of Oleic Acid, Stearic acid and Ammonia is also available (publication) in which a bacterial reverse mutation assay using 6 bacterial strains (Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 and Escherichia coli WP2 uvrA) and Oleic Acid, Stearic acid and Ammonia with and without rat liver S9 mix (induced with polychlorated biphenyls) is described. DMSO, Acetone and Air served as a vehicle. As positive controls, benzo(a)pyrene, 2-nitrofluorene, 9-aminoacridine, N-ethyl-N-nitro-N-nitrosoguanidine, 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, 4-nitroquinoline-1-oxide and 2-aminoanthracene were used. The revertant colonies were counted using an automated colony counter. As results, this structural analogue substances were not mutagenic in a bacterial reverse mutation assay, neither with nor without metabolic activation.
The target substance Fatty acids, C14-18 and C16-18-unsatd., ammonium salts consists of ammonium salts of the fatty acids Myristic Acid (C14 ), Palmitic acid (C16), Stearic acid (C18), Palmitoleic acid (C16:1), Oleic acid (C18:1), Linoleic acid (C18:2) and Linolenic acid (C18:3). Oleic Acid (as representative of the unsaturated fatty acids and main constituent of fatty acids), Stearic acid (as representative of the saturated fatty acids) and Ammonia (as representative of the ammonium cation) are structurally similar to the target substance to the analogue substances. Therefore the results of the genetic toxicity in vitro of the source substances can be assigned to the target substance ( weight of evidence approach).
Justification for classification or non-classification
DSD (67/548/EEC):
The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the (target) substance is not considered to be classified for genetic toxicity under Directive 67/548/EEC.
CLP/GHS (Regulation (EC) No 1272/2008):
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008.
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