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EC number: 306-227-4 | CAS number: 96690-34-5
- 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:
- key study
- Study period:
- 11- 30 Jul 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
- EC Number:
- 306-227-4
- EC Name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
- Cas Number:
- 96690-34-5
- Molecular formula:
- C4H11O4P to C8H20O7P2 as representative molecular formula of the composition as specified in section 1.2
- IUPAC Name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male Wistar rats induced with phenobarbital (80 mg/kg bw) and β-naphthoflavone (100 mg/kg bw).
- Test concentrations with justification for top dose:
- Preliminary cytotoxicity test: 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate with and without metabolic activation
Experiment I: 3.16, 10.0, 31.6, 100, 316, 1000 and 2500 µg/plate with and without metabolic activation
Experiment II: 0.50, 1.58, 5.0, 15.8, 50, 158, 500 and 1580 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: the solvent was compatible with the survival of bacteria and S9 activity
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- yes
- Remarks:
- aqua dest.
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (10 µg/plate) for TA100 and TA1535; 4-nitro-o-phenylene-diamine (10 or 40 µg/plate) for TA98 and TA1537; methylmethanesulfonate (1 µL/plate) for TA102; +S9: 2-aminoanthracene (2.5 or 10 µg/plate) for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of the bacterial background lawn or reduction in the number of revertants down to a mutation factor of ca. ≤ 0.5 compared to solvent control. - Evaluation criteria:
- EVALUATION OF MUTAGENICITY
The Mutation Factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control (the exact and not the rounded values were used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occur and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with and without metabolic activation.
A biologically relevant increase is described as follows:
- if in the tester strains TA 98, TA 00 and TA 102 the number of reversions is at least twice as high than the reversion rate of the solvent control.
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
A test item producing neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- A statistical evaluation of the results was not regarded as necessary since the biological relevance is the criterion for interpretation of results according to OECD 471.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: ≥ 316 µg/plate (-S9); ≥ 1000 µg/plate (+S9); Exp. II: ≥ 50 µg/plate (-S9), ≥ 500 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: ≥ 100 µg/plate (-S9); ≥ 1000 µg/plate (+S9); Exp. II: ≥ 156 µg/plate (-S9), ≥ 1580 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: ≥ 316 µg/plate (-S9); ≥ 1000 µg/plate (+S9); Exp. II: ≥ 158 µg/plate (-S9), ≥ 1580 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: ≥ 316 µg/plate (-S9); ≥ 316 µg/plate (+S9); Exp. II: ≥ 50 µg/plate (-S9), ≥ 500 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: ≥ 316 µg/plate (-S9); ≥ 1000 µg/plate (+S9); Exp. II: ≥ 67 µg/plate (-S9), ≥ 1580 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: a preliminary cytotoxicity experiment in TA 98 and TA 100 was performed to determine appropriate concentrations for treatment in the main experiment. Cytotoxicity in TA 98 was observed at concentrations of ≥ 316 µg/plate in the absence of S9 mix and at concentrations of ≥ 1000 µg/plate in the presence of S9 mix. For TA 100, cytotoxic effects were observed at ≥ 100 µg/plate with and without S9 mix, respectively. In both strains, no bacterial background lawn was observed at ≥ 2500 µg/plate (with S9 mix) and at ≥ 5000 µg/plate (with and without S9 mix). Therefore, the highest concentration used in the main experiment was 2500 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: in experiment I in tester strain TA 102 (without metabolic activation), the mean value of revertant colony numbers of the negative control (aqua dest.) was below the lower limit of the historical control data for the negative control. Since the values fell only slightly below the lower limit of the control data, the data were considered as valid.
ADDITIONAL INFORMATION ON CYTOTOXICITY: in experiment I, in the absence of S9 mix, cytotoxicity was observed at concentrations ≥ 100 µg/plate in tester strain TA 1537 and at ≥ 316 µg/plate in the remaining tester strains. In the presence of S9 mix, cytotoxicity was evident at concentrations ≥ 1000 µg/plate in all tester strains, except for TA 100, in which cytotoxicity was already seen at ≥ 316 µg/plate. In experiment II, cytotoxic effects were already visible at concentrations ≥ 50 µg/plate in TA 100, TA 1535 and TA 1537 in the absence of S9 mix. In TA 98 and TA 102, cytotoxicity was observed without S9 mix at concentrations ≥ 158 and 500 µg/plate, respectively. In the presence of S9 mix, tester strains TA 100 and TA 1535 showed cytotoxicity at ≥ 500 µg/plate, whereas in the remaining tester strains cytotoxicity was seen at ≥ 1580 µg/plate.
Any other information on results incl. tables
Table 3. Test results of experiment I (plate incorporation)
Bacterial Reverse Mutation Assay, mean revertant colonies/plate (mutation factor) (n=3 ± SD) |
|||||
EXPERIMENT I |
|||||
S9-Mix |
Without
|
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
NC |
23 ± 2 (0.7) |
129 ± 8 (1.2) |
11 ± 4 (0.7) |
14 ± 2 (1.0) |
161 ± 11 (0.9) |
SC |
30 ± 5 (1.0) |
103 ± 6 (1.0) |
16 ± 6 (1.0) |
14 ± 6 (1.0) |
181 ± 8 (1.0) |
Test item |
|
|
|
|
|
3.16 µg |
30 ± 2 (1.0) |
129 ± 7 (1.2) |
12 ± 2 (0.8) |
11 ± 4 (0.8) |
193 ± 21 (1.1) |
10.0 µg |
26 ± 5 (0.9) |
124 ± 12 (1.2) |
10 ± 3 (0.6) |
9 ± 2 (0.6) |
224 ± 12 (1.2) |
31.6 µg |
31 ± 2 (1.0) |
119 ± 17 (1.2) |
19 ± 8 (1.2) |
10 ± 1 (0.7) |
184 ± 20 (1.0) |
100 µg |
22 ± 5 (0.7) |
100 ± 37 (1.0) |
24 ± 7 (1.5) |
11 ± 5B (0.8) |
169 ± 72 (0.9) |
316 µg |
16 ± 6B (0.5) |
66 ± 16B (0.6) |
36 ± 16B (2.2) |
24 ± 6B (1.7) |
68 ± 72B (0.4) |
1000 µg |
7 ± 3B (0.2) |
36 ± 54B (0.3) |
1 ± 2B (0.1) |
6 ± 10B (0.4) |
0 ± 0B (0.0) |
2500 µg |
0 ± 0N (0.0) |
0 ± 0N (0.0) |
0 ± 0N (0.0) |
0 ± 0N (0.0) |
0 ± 0N (0.0) |
PC |
|
|
|
|
|
NaN3 (10 µg) |
- |
948 ± 123 (9.2) |
931 ± 14 (58.2) |
- |
- |
2AA (2.5 µg) |
- |
- |
- |
- |
- |
2-AA (10 µg) |
- |
- |
- |
- |
- |
4NOPD (10 µg) |
492 ± 33 (16.2) |
- |
- |
- |
- |
4NOPD (40 µg) |
- |
- |
- |
137 ± 4 (9.8) |
- |
MMS (1 µL) |
- |
- |
- |
- |
1074 ± 146 (5.9) |
S9-Mix
|
With |
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
NC |
33 ± 7 (1.0) |
147 ± 6 (1.0) |
13 ± 2 (0.9) |
7 ± 2 (1.0) |
238 ± 15 (1.0) |
SC |
34 ± 4 (1.0) |
145 ± 17 (1.0) |
14 ± 1 (1.0) |
7 ± 3 (1.0) |
237 ± 18 (1.0) |
Test material |
|
|
|
|
|
3.16 µg |
37 ± 3 (1.1) |
122 ± 28 (0.8) |
15 ± 6 (1.0) |
9 ± 1 (1.2) |
229 ± 20 (1.0) |
10.0 µg |
39 ± 3 (1.1) |
134 ± 28 (0.9) |
14 ± 4 (1.0) |
8 ± 3 (1.1) |
215 ± 15 (0.9) |
31.6 µg |
34 ± 6 (1.0) |
132 ± 13 (0.9) |
18 ± 2 (1.3) |
6 ± 2 (0.9) |
244 ± 44 (1.0) |
100 µg |
40 ± 8 (1.2) |
137 ± 19 (0.9) |
14 ± 5 (1.0) |
5 ± 1 (0.7) |
263 ± 36 (1.1) |
316 µg |
28 ± 3 (0.8) |
89 ± 28B (0.6) |
19 ± 6 (1.3) |
7 ± 5 (1.0) |
194 ± 33 (0.8) |
1000 µg |
24 ± 6B (0.7) |
46 ± 18B (0.3) |
17 ± 6B (1.2) |
2 ± 1B (0.3) |
84 ± 4 (0.4) |
2500 µg |
1 ± 1B (0.0) |
3 ± 5B (0.0) |
0 ± 0B/N (0.0) |
0 ± 0N (0.0) |
0 ± 0B (0.0) |
PC |
|
|
|
|
|
NaN3 (10 µg) |
- |
- |
- |
- |
- |
2AA (2.5 µg) |
3089 ± 278 (90.8) |
1517 ± 214 (10.5) |
125 ± 17 (8.7) |
273 ± 32 (39.0) |
- |
2-AA (10 µg) |
- |
- |
- |
- |
497 ± 32 (2.1) |
4NOPD (10 µg) |
- |
- |
- |
- |
- |
4NOPD (40 µg) |
- |
- |
- |
- |
- |
MMS (1 µL) |
- |
- |
- |
- |
- |
NC = Negative control (aqua dest.), SC = Solvent control (ethanol); PC = Positive control substances; SD = standard deviation, B = background lawn reduced, N = no background lawn; 4NOPD = 4-nitro-o-phenylene-diamine, 2AA = 2-aminoanthracene, NaN3 = sodium azide, MMS = methylmethane-sulfonate; Mutation factor = mean revertants (test item)/ mean revertants (solvent control) |
Table 4. Test results of experiment II (plate incorporation)
Bacterial Reverse Mutation Assay, mean revertant colonies/plate (mutation factor) (n=3 ± SD) |
|||||
EXPERIMENT II |
|||||
S9-Mix |
Without
|
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
NC |
20 ± 6 (0.7) |
127 ± 12 (1.1) |
6 ± 2 (1.1) |
6 ± 4 (0.8) |
184 ± 0 (0.9) |
SC |
27 ± 8 (1.0) |
113 ± 5 (1.0) |
5 ± 2 (1.0) |
7 ± 1 (1.0) |
213 ± 8 (1.0) |
Test item |
|
|
|
|
|
0.5 µg |
22 ± 5 (0.8) |
132 ± 16 (1.2) |
9 ± 3 (1.7) |
6 ± 1 (0.9) |
190 ± 12 (0.9) |
1.58 µg |
21 ± 1 (0.8) |
113 ± 5 (1.0) |
4 ± 1 (0.8) |
7 ± 1 (1.0) |
191 ± 31 (0.9) |
5.0 µg |
20 ± 8 (0.7) |
136 ± 35 (1.2) |
4 ± 2 (0.8) |
7 ± 1 (1.0) |
198 ± 48 (0.9) |
15.8 µg |
24 ± 2 (0.9) |
107 ± 9 (1.0) |
8 ± 3 (1.5) |
6 ± 4 (0.8) |
184 ± 6 (0.9) |
50 µg |
21 ± 7 (0.8) |
88 ± 9B (0.8) |
3 ± 1B (0.6) |
4 ± 1 (0.5) |
186 ± 8 (0.9) |
158 µg |
22 ± 4B (0.8) |
76 ± 22B (0.7) |
3 ± 3B (0.5) |
6 ± 2B (0.8) |
158 ± 12 (0.7) |
500 µg |
19 ± 2B (0.7) |
2 ± 4B (0.0) |
0 ± 0B (0.0) |
0 ± 0B/N (0.0) |
67 ± 13B (0.3) |
1580 µg |
0 ± 0N (0.0) |
0 ± 0N (0.0) |
0 ± 0N (0.0) |
0 ± 0N (0.0) |
13 ± 23B/N (0.1) |
PC |
|
|
|
|
|
NaN3 (10 µg) |
- |
771 ± 59 (6.8) |
744 ± 149 (139.6) |
- |
- |
2AA (2.5 µg) |
- |
- |
- |
- |
- |
2-AA (10 µg) |
- |
- |
- |
- |
- |
4NOPD (10 µg) |
284 ± 11 (10.4) |
- |
- |
- |
- |
4NOPD (40 µg) |
- |
- |
- |
72 ± 16 (9.9) |
- |
MMS (1 µL) |
- |
- |
- |
- |
1225 ± 36 (5.7) |
S9-Mix
|
With |
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
NC |
24 ± 2 (0.8) |
147 ± 30 (1.1) |
7 ± 3 (1.2) |
6 ± 1 (0.9) |
263 ± 8 (1.1) |
SC |
30 ± 3 (1.0) |
134 ± 23 (1.0) |
6 ± 2 (1.0) |
7 ± 5 (1.0) |
243 ± 36 (1.0) |
Test material |
|
|
|
|
|
0.5 µg |
45 ± 8 (1.5) |
142 ± 15 (1.1) |
10 ± 5 (1.8) |
11 ± 5 (1.7) |
236 ± 16 (1.0) |
1.58 µg |
27 ± 7 (0.9) |
155 ± 5 (1.2) |
10 ± 5 (1.8) |
8 ± 4 (1.2) |
273 ± 39 (1.1) |
5.0 µg |
25 ± 6 (0.8) |
151 ± 20 (1.1) |
7 ± 2 (1.2) |
6 ± 3 (0.9) |
261 ± 10 (1.1) |
15.8 µg |
31 ± 1 (1.0) |
138 ± 9 (1.0) |
7 ± 2 (1.2) |
8 ± 4 (1.2) |
236 ± 29 (1.0) |
50 µg |
34 ± 5 (1.2) |
129 ± 5 (1.0) |
4 ± 3 (0.8) |
7 ± 5 (1.1) |
272 ± 45 (1.1) |
158 µg |
42 ± 4 (1.4) |
115 ± 20 (0.9) |
8 ± 2 (1.4) |
6 ± 5 (0.9) |
269 ± 22 (1.1) |
500 µg |
30 ± 6 (1.0) |
78 ± 8B (0.6) |
7 ± 3B (1.2) |
7 ± 5 (1.1) |
206 ± 10 (0.9) |
1580 µg |
1 ± 1B (0.0) |
0 ± 0B/N (0.0) |
0 ± 0B (0.0) |
1 ± 1B (0.1) |
70 ± 10B (0.3) |
PC |
|
|
|
|
|
NaN3 (10 µg) |
- |
- |
- |
- |
- |
2AA (2.5 µg) |
2393 ± 641 (80.7) |
1902 ± 282 (14.2) |
91 ± 20 (16.0) |
290 ± 139 (43.5) |
- |
2-AA (10 µg) |
- |
- |
- |
- |
534 ± 32 (2.2) |
4NOPD (10 µg) |
- |
- |
- |
- |
- |
4NOPD (40 µg) |
- |
- |
- |
- |
- |
MMS (1 µL) |
- |
- |
- |
- |
- |
NC = Negative control (aqua dest.), SC = Solvent control (ethanol); PC = Positive control substances; SD = standard deviation, B = background lawn reduced, N = no background lawn; 4NOPD = 4-nitro-o-phenylene-diamine, 2AA = 2-aminoanthracene, NaN3 = sodium azide, MMS = methylmethane-sulfonate; Mutation factor = mean revertants (test item)/ mean revertants (solvent control) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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.
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