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EC number: 205-596-8 | CAS number: 143-27-1
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Data from summary document with only 4 strains; acceptable because data consistent with other data in subcategory. The endpoint has been adequately characterized. (American Chemistry Council, Fatty Nitrogen Derivatives Panel, Amines Task Group).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hexadecylamine
- EC Number:
- 205-596-8
- EC Name:
- Hexadecylamine
- Cas Number:
- 143-27-1
- Molecular formula:
- C16H35N
- IUPAC Name:
- hexadecan-1-amine
- Test material form:
- solid
1
Method
- Target gene:
- Histidine (S. typhimurium)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S-9 (9,000g supernatant) fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared as described previously [Haworth et al, 1983]. The S-9 mixes were prepared immediately prior to use and contained either 10% or 30% S-9. The test substance was tested in the absence of metabolic activation and with rat and hamster S-9 fractions.
- Test concentrations with justification for top dose:
- 0.3, 1.0, 3, 10, 33, 100 µg/plate based on toxicity pretest
- Vehicle / solvent:
- DSMO
Controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine: TA98 (without S9); 2-aminoan-thracene: all strains (with S9)
- Details on test system and experimental conditions:
- The preincubation assay was performed as described previously [Haworth et al., 1983], with some differences, as described below. The test chemical (0.05 ml), Salmonella culture (0.10 ml), and S-9 mix or buffer (0.50 ml) were incubated at 37°C, without shaking, for 20 min. Chemicals known or suspected to be volatile were incubated in capped tubes. The top agar was added and the contents of the tubes were mixed and poured onto the surface of petri dishes containing Vogel-Bonner medium [Vogel and Bonner, 1956]. The histidine-independent (his+) colonies arising on these plates were counted following two days incubation at 37°C. Plates were machine counted (New Brunswick, Edison, NJ; Artek, Farmingdale, NY) unless precipitate was present which interfered with the count, or the color of the test chemical on the plate reduced the contrast between the colonies and the background agar. At the discretion of the investigators, plates with low numbers of colonies were counted by hand.
Variations in the protocol among the tested chemicals reflect the evolution of the protocol originally described by Haworth et al. [1983].
The test substance was tested initially in a toxicity assay to determine the appropriate dose range for the mutagenicity assay. The toxicity assay was performed using TA100 or the sytem developed by Waleh et al. [1982]. Toxic concentrations were those that produced a decrease in the number of his+ colonies, or a clearing in the density of the background lawn, or both. The test substance was tested initially at half-log dose intervals up to a dose that elicited toxicity, or to a dose immediately below one which was toxic in the preliminary toxicity test. Subsequent trials occasionally used narrower dose increments and may not have included doses in the toxic range. Concurrent solvent and positive controls were run. The positive controls in the absence of metabolic activation were sodium azide (TA1535 and TA100), 9-aminoacridine (TA97 and TA1537), and 4-nitro-o-phenylenediamine (TA98). The positive control for metabolic activation with all strains was 2-aminoan-thracene. - Evaluation criteria:
- The data were evaluated as described previously [Zeiger et al., 1987]. Evaluations were made at both the individual trial and overall chemical levels. Individual trials were judged mutagenic (+), weakly mutagenic (+W), questionable (?), or nonmutagenic (-), depending on the magnitude of the increase of his+ revertants, and the shape of the dose-response. A trial was considered questionable (?) if the dose-response was judged insufficiently high to support a call of " +W," if only a single dose was elevated over the control, or if the increase seen was not dose related. The distinctions between a questionable mutagenic response and a nonmutagenic or weak mutagenic response and between a weak mutagenic response and mutagenic response are highly subjective. It was not necessary for a response to reach twofold over background for a chemical to be judged mutagenic. A chemical was judged mutagenic (+) or weakly mutagenic (+W) if it produced a reproducible dose-related response over the solvent control in replicate trials. A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his4" revertants did not meet the criteria for a "+W" response, or if only single doses produced increases in his +revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet the criteria for a mutagenic or questionable response. The chemicals were decoded by the chemical repository only after a determination had been made regarding their mutagenicity or nonmutagenicity.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 97, 98, 100, 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 µg/plate
- Vehicle controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No historical control data is available, but the control plates without activation were comparable to that described in literature.
Any other information on results incl. tables
Table 1: Detailed results for TA100 and TA1535
Dose |
TA100 |
TA1535 |
||||||||||||||||||
NA |
10% HLI |
30% HLI |
10% RLI |
30% RLI |
NA |
10% HLI |
30% HLI |
10% RLI |
30% RLI |
|||||||||||
µg/PLATE |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
0.000 |
120 |
3.1 |
108 |
1.3 |
127 |
7.9 |
118 |
4.4 |
142 |
1.9 |
10 |
3.4 |
6 |
2.2 |
16 |
1.9 |
6 |
0.9 |
9 |
2.6 |
0.300 |
106 |
3.1 |
|
|
|
|
|
|
|
|
15 |
4.3 |
|
|
|
|
|
|
|
|
1.000 |
93 |
5.5 |
113 |
28.5 |
131 |
2.9 |
130 |
33.5 |
127 |
17.1 |
17 |
2.5 |
12 |
5.8 |
13 |
0.7 |
8 |
2.8 |
17 |
4.0 |
3.000 |
63 |
4.2 |
110 |
17.3 |
117 |
10.5 |
119 |
8.5 |
110 |
9.9 |
11 |
3.2 |
6 |
0.7 |
7 |
1.3 |
7 |
1.5 |
7 |
1.7 |
10.000 |
73 |
6.8 |
121 |
6.9 |
131 |
5.2 |
165 |
15.0 |
113 |
12.7 |
15 |
0.9 |
7 |
1.0 |
9 |
3.0 |
7 |
1.0 |
12 |
1.9 |
33.000 |
69 |
9.8 |
116 |
15.0 |
124 |
9.0 |
161 |
12.5 |
114 |
9.3 |
12 |
2.3 |
10 |
1.5 |
9 |
0.3 |
8 |
3.2 |
8 |
1.9 |
100.000 |
|
|
78 |
10.0 |
112 |
7.2 |
97 |
5.5 |
134 |
13.7 |
|
|
8 |
3.0 |
5 |
1.3 |
4 |
0.9 |
9 |
0.9 |
POS |
274 |
5.2 |
2127 |
115.0 |
748 |
9.6 |
1380 |
84.1 |
352 |
4.6 |
186 |
3.0 |
635 |
8.0 |
534 |
33.8 |
460 |
24.6 |
110 |
11.1 |
Abbreviations:
POS: positive control
NA: not activated
HLI: Aroclor 1254-induced hamster liver S-9
RLI: Aroclor 1254-induced rat liver S-9
Table 2: Detailed results of TA97 and TA98
Dose |
TA97 |
TA98 |
||||||||||||||||||
NA |
10% HLI |
30% HLI |
10% RLI |
30% RLI |
NA |
10% HLI |
30% HLI |
10% RLI |
30% RLI |
|||||||||||
µg/PLATE |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
mean |
SD |
0.000 |
153 |
2.6 |
216 |
5.2 |
173 |
9.2 |
216 |
15.6 |
224 |
7.6 |
12 |
3.7 |
45 |
5.7 |
22 |
2.5 |
34 |
1.7 |
21 |
0.9 |
0.300 |
155 |
2.6 |
|
|
|
|
|
|
|
|
11 |
1.3 |
|
|
|
|
|
|
|
|
1.000 |
140 |
9.8 |
255 |
19.7 |
199 |
30.0 |
255 |
11.8 |
234 |
12.2 |
14 |
3.2 |
39 |
6.9 |
22 |
2.3 |
35 |
3.5 |
28 |
0.9 |
3.000 |
126 |
9.0 |
230 |
3.3 |
183 |
15.9 |
235 |
19.3 |
191 |
13.3 |
7 |
0.6 |
35 |
11.2 |
21 |
1.5 |
28 |
1.5 |
25 |
2.8 |
10.000 |
114 |
6.1 |
255 |
11.3 |
191 |
16.3 |
286 |
11.3 |
207 |
14.3 |
10 |
1.5 |
36 |
2.0 |
15 |
2.0 |
31 |
4.7 |
15 |
2.5 |
33.000 |
101 |
4.0 |
225 |
9.0 |
182 |
12.3 |
265 |
4.2 |
204 |
11.3 |
9 |
2.3 |
32 |
2.0 |
13 |
3.4 |
26 |
0.9 |
19 |
4.0 |
100.000 |
|
|
195 |
14.2 |
192 |
5.2 |
212 |
15.0 |
203 |
9.6 |
|
|
21 |
4.1 |
13 |
3.5 |
22 |
6.0 |
23 |
3.5 |
POS |
106 |
141.6 |
1121 |
53.1 |
1007 |
50.1 |
1767 |
80.4 |
579 |
7.0 |
740 |
9.8 |
1207 |
133.9 |
234 |
7.0 |
830 |
110.3 |
151 |
3.7 |
Abbreviations:
POS: positive control
NA: not activated
HLI: Aroclor 1254-induced hamster liver S-9
RLI: Aroclor 1254-induced rat liver S-9
Applicant's summary and conclusion
- Conclusions:
- Based on the test results it can be stated that the test item is not mutagenic in the strains TA 100, TA 1535, TA 97 and TA 98 of Salmonella typhimurium with and without metabolic activation.
- Executive summary:
The test item was tested for mutagenicity with the strains TA 100, TA 1535, TA97 and TA 98 of Salmonella typhimurium. The mutagenicity study was conducted in the absence and in the presence of a metabolizing system derived from rat and hamster liver homogenate. Control plates without mutagen showed that the number of spontaneous revertant colonies was comparable to that described in literatur. All the positive control compounds gave the expected increase in the number of revertant colonies. In the cytotoxicity trials, the test compound proved to be toxic to most of the bacterial strains at 100 microgram/plate. These tests demonstrated that in the presence or absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Summarizing, it can be stated that the test item is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.
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