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EC number: 402-920-1 | CAS number: 103300-89-6 N-6-TRIFLUORACETYL-L-LYSYL-L-PROLIN; T.F.A. LYS PRO; TFA-LYS-PRO
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-06-22 to 1990-07-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(N6-trifluoroacetyl-L-lysyl)-L-proline
- EC Number:
- 402-920-1
- EC Name:
- N-(N6-trifluoroacetyl-L-lysyl)-L-proline
- Cas Number:
- 103300-89-6
- Molecular formula:
- C13H20F3N3O4
- IUPAC Name:
- (2S)-1-[(2R)-2-amino-6-(2,2,2-trifluoroacetamido)hexanoyl]pyrrolidine-2-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- His locus
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Due to migration, the value was transferred to one of the current document's attachments
- Test concentrations with justification for top dose:
- Concentration range in the preliminary test (with metabolic activation) 0, 5.0, 50.0, 500.0, 5000.0, 50000.0 µg/plate
Concentration range in the preliminary test (without metabolic activation) 0, 5.0, 50.0, 500.0, 5000.0, 50000.0 µg/plate
Concentration range in the main test (with metabolic activation): 0, 620, 1850, 5560, 16670, 50000 µg/plate
Concentration range in the main test (without metabolic activation): 0, 620, 1850, 5560, 16670, 50000 µg/plate - Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable):
Experiment 1:
TA1535: 3.5E+08 cells/mL
TA1537: 1.5E+08 cells/mL
TA1538: 1.9E+08 cells/mL
TA98: 2.5E+08 cells/mL
TA100: 4.6E+08 cells/mL
Experiment 2:
TA1535: 1.2E+08 cells/mL
TA1537: 4.5E+07 cells/mL
TA1538: 2.5E+08 cells/mL
TA98: 1.8E+08 cells/mL
TA100: 1.8E+08 cells/mL
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 72h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition
METHODS FOR MEASUREMENTS OF GENOTOXICIY
A positive response in the assay system is taken to be a two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background spontaneous reversion rate observed with the vehicle, together with evidence of a dose-response. - Rationale for test conditions:
- As recommended by the guideline
- Evaluation criteria:
- A positive response in the assay system is taken to be a two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background spontaneous reversion rate observed with the vehicle, together with evidence of a dose-response.
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:
- (> 50000 µg/plate)
- 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:
- (> 50000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 50000 µg/plate)
- 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:
- (> 50000 µg/plate)
- 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:
- > 50000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES (if applicable):
A preliminary test was performed at the following concentrations:
Concentration range in the preliminary test (with metabolic activation) 0, 5.0, 50.0, 500.0, 5000.0, 50000.0 µg/plate
Concentration range in the preliminary test (without metabolic activation) 0, 5.0, 50.0, 500.0, 5000.0, 50000.0 µg/plate
the test substance was not toxic for all strains at all dose levels, thus the highest concentration in the main test was 50000 µg/plate
STUDY RESULTS
- Concurrent vehicle negative and positive control data
Experiment 1:
negative control
-S9: TA1535: 21 ± 2; TA1537: 18 ± 5; TA1538: 27 ± 7; TA98: 48 ± 8; TA100: 78 ± 18
+S9:TA1535: 24 ± 3; TA1537: 23 ± 3; TA1538: 60 ± 10; TA98: 68 ± 3; TA100: 82 ± 3
positive control:
-S9: TA1535: 691 ± 84; TA1537: 1361 ± 310; TA1538: 1367 ± 60; TA98: 857 ± 56; TA100: 839 ± 26
+S9:TA1535: 226 ± 26; TA1537: 216 ± 42; TA1538: 812 ± 17; TA98: 669 ± 47; TA100: 610 ± 46
Experiment 2:
negative control
-S9: TA1535: 66 ± 6; TA1537: 11 ± 4; TA1538: 26 ± 5; TA98: 51 ± 7; TA100: 170 ± 5
+S9:TA1535: 17 ± 1; TA1537: 17 ± 5; TA1538: 47 ± 3; TA98: 72 ± 20; TA100: 149 ± 8
positive control:
-S9: TA1535: 734 ± 113; TA1537: 1820 ± 202; TA1538: 1033 ± 27; TA98: 627 ± 74; TA100: 719 ± 123
+S9:TA1535: 213 ± 25; TA1537: 327 ± 120; TA1538: 643 ± 24; TA98: 420 ± 26; TA100: 544 ± 41
For all test methods and criteria for data analysis and interpretation:
- Statistical analysis; p-value if any : No statistical analysis was reported
Ames test:
- Signs of toxicity yes at > 50000µg/plate
- Individual plate counts :
Experiment 1:
TA1535: 3.5E+08 cells/mL
TA1537: 1.5E+08 cells/mL
TA1538:1.9E+08 cells/mL
TA98: 2.5E+08 cells/mL
TA100: 4.6E+08 cells/mL
Experiment 2:
TA1535: 1.2E+08 cells/mL
TA1537: 4.5E+07 cells/mL
TA1538:2.5E+08 cells/mL
TA98: 1.8E+08 cells/mL
TA100: 1.8E+08 cells/mL
- Mean number of revertant colonies per plate and standard deviation
Experiment 1:
TA1535: 18
TA1537: 15
TA1538:24
TA98: 37
TA100: 89
Experiment 2:
TA1535: 33
TA1537: 18
TA1538:24
TA98: 25
TA100: 182
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data) not reported - Remarks on result:
- other:
Any other information on results incl. tables
Experiments 1: Results
Dose µg/plate |
|
TA1535 |
TA1537 |
TA1538 |
TA98 |
TA100 |
|||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
||
0 |
|
22 |
21 |
12 |
21 |
20 |
58 |
42 |
67 |
79 |
80 |
22 |
26 |
19 |
21 |
27 |
52 |
45 |
71 |
95 |
82 |
||
18 |
26 |
22 |
27 |
34 |
71 |
57 |
65 |
60 |
85 |
||
Mean |
21 |
24 |
18 |
23 |
27 |
60 |
48 |
68 |
78 |
82 |
|
SD |
2 |
3 |
5 |
3 |
7 |
10 |
8 |
3 |
18 |
3 |
|
620 |
|
19 |
22 |
17 |
22 |
26 |
62 |
49 |
64 |
67 |
71 |
22 |
26 |
17 |
24 |
22 |
63 |
38 |
73 |
85 |
80 |
||
21 |
29 |
21 |
19 |
32 |
56 |
40 |
67 |
80 |
89 |
||
Mean |
21 |
26 |
18 |
22 |
27 |
60 |
42 |
68 |
77 |
80 |
|
SD |
2 |
4 |
2 |
3 |
5 |
4 |
6 |
5 |
9 |
9 |
|
1850 |
|
22 |
19 |
18 |
25 |
36 |
81 |
38 |
68 |
103 |
103 |
21 |
24 |
19 |
27 |
43 |
70 |
33 |
73 |
106 |
97 |
||
24 |
18 |
22 |
21 |
40 |
61 |
50 |
64 |
107 |
120 |
||
Mean |
22 |
20 |
20 |
24 |
40 |
71 |
40 |
68 |
105 |
107 |
|
SD |
2 |
3 |
2 |
3 |
4 |
10 |
9 |
5 |
2 |
12 |
|
5560 |
|
24 |
22 |
25 |
27 |
28 |
44 |
35 |
82 |
105 |
95 |
17 |
22 |
19 |
30 |
31 |
69 |
50 |
76 |
74 |
85 |
||
21 |
29 |
19 |
27 |
30 |
65 |
51 |
72 |
80 |
83 |
||
Mean |
21 |
24 |
21 |
28 |
30 |
59 |
45 |
77 |
86 |
88 |
|
SD |
4 |
4 |
3 |
2 |
2 |
13 |
9 |
5 |
16 |
6 |
|
16670 |
|
24 |
15 |
9 |
19 |
16 |
55 |
34 |
96 |
72 |
89 |
17 |
17 |
13 |
29 |
22 |
57 |
44 |
111 |
77 |
105 |
||
29 |
19 |
14 |
30 |
27 |
64 |
36 |
82 |
86 |
93 |
||
Mean |
23 |
17 |
12 |
26 |
22 |
59 |
38 |
96 |
78 |
96 |
|
SD |
6 |
2 |
3 |
6 |
6 |
5 |
5 |
15 |
7 |
8 |
|
50000 |
|
18 |
14 |
9 |
19 |
27 |
42 |
14 |
52 |
127 |
128 |
11 |
18 |
10 |
13 |
24 |
39 |
20 |
63 |
123 |
115 |
||
19 |
13 |
17 |
17 |
19 |
36 |
22 |
39 |
100 |
116 |
||
Mean |
16 |
15 |
16 |
16 |
23 |
39 |
19 |
51 |
117 |
120 |
|
SD |
4 |
3 |
3 |
3 |
4 |
3 |
4 |
12 |
15 |
7 |
|
Pos. C. |
|
613 |
223 |
025 |
245 |
1436 |
826 |
908 |
624 |
840 |
567 |
780 |
201 |
635 |
235 |
1338 |
793 |
797 |
664 |
813 |
659 |
||
679 |
253 |
422 |
168 |
1326 |
816 |
865 |
718 |
865 |
605 |
||
Mean |
691 |
226 |
361 |
216 |
1367 |
812 |
857 |
669 |
839 |
610 |
|
SD |
84 |
26 |
310 |
42 |
60 |
17 |
56 |
47 |
26 |
46 |
Experiment 2: Results:
Dose µg/plate |
|
TA1535 |
TA1537 |
TA1538 |
TA98 |
TA100 |
|||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
||
0 |
|
28 |
17 |
12 |
17 |
22 |
43 |
43 |
94 |
174 |
157 |
17 |
17 |
7 |
12 |
24 |
48 |
57 |
64 |
165 |
148 |
||
20 |
18 |
14 |
22 |
22 |
49 |
54 |
57 |
172 |
141 |
||
Mean |
22 |
17 |
11 |
17 |
26 |
47 |
51 |
72 |
170 |
149 |
|
SD |
6 |
1 |
4 |
5 |
5 |
3 |
7 |
20 |
5 |
8 |
|
620 |
|
25 |
19 |
13 |
21 |
20 |
43 |
39 |
62 |
174 |
184 |
37 |
14 |
16 |
8 |
22 |
53 |
48 |
61 |
159 |
165 |
||
36 |
16 |
23 |
22 |
32 |
54 |
48 |
78 |
168 |
150 |
||
Mean |
33 |
16 |
17 |
17 |
25 |
50 |
45 |
67 |
167 |
166 |
|
SD |
7 |
3 |
5 |
8 |
6 |
6 |
5 |
10 |
8 |
17 |
|
1850 |
|
33 |
33 |
12 |
15 |
25 |
57 |
53 |
76 |
177 |
160 |
29 |
28 |
12 |
21 |
36 |
57 |
39 |
89 |
212 |
177 |
||
30 |
25 |
12 |
20 |
30 |
61 |
40 |
73 |
182 |
191 |
||
Mean |
31 |
29 |
12 |
19 |
30 |
58 |
44 |
79 |
190 |
176 |
|
SD |
2 |
4 |
0 |
3 |
6 |
2 |
8 |
9 |
19 |
16 |
|
5560 |
|
17 |
23 |
18 |
22 |
27 |
54 |
34 |
74 |
182 |
191 |
34 |
25 |
13 |
20 |
27 |
49 |
39 |
65 |
190 |
209 |
||
25 |
16 |
24 |
23 |
34 |
47 |
33 |
73 |
172 |
194 |
||
Mean |
25 |
21 |
18 |
22 |
29 |
50 |
35 |
71 |
181 |
198 |
|
SD |
9 |
5 |
6 |
2 |
4 |
4 |
3 |
5 |
9 |
10 |
|
16670 |
|
11 |
21 |
16 |
16 |
15 |
54 |
56 |
73 |
168 |
158 |
30 |
22 |
12 |
16 |
21 |
53 |
48 |
57 |
162 |
169 |
||
26 |
21 |
18 |
18 |
21 |
44 |
52 |
80 |
180 |
156 |
||
Mean |
22 |
21 |
15 |
17 |
19 |
50 |
52 |
70 |
170 |
161 |
|
SD |
10 |
1 |
3 |
1 |
3 |
6 |
4 |
12 |
9 |
7 |
|
50000 |
|
21 |
20 |
12 |
26 |
15 |
41 |
25 |
65 |
146 |
172 |
11 |
16 |
2 |
18 |
37 |
35 |
26 |
43 |
156 |
170 |
||
19 |
12 |
15 |
15 |
36 |
43 |
24 |
49 |
154 |
163 |
||
Mean |
17 |
16 |
10 |
20 |
29 |
40 |
25 |
52 |
152 |
168 |
|
SD |
5 |
4 |
7 |
6 |
12 |
4 |
1 |
11 |
5 |
5 |
|
Pos. C. |
|
604 |
190 |
1590 |
440 |
1002 |
627 |
542 |
450 |
818 |
586 |
801 |
240 |
1905 |
201 |
1051 |
631 |
674 |
404 |
581 |
543 |
||
798 |
210 |
1966 |
341 |
1045 |
670 |
665 |
406 |
758 |
504 |
||
Mean |
734 |
213 |
1820 |
327 |
1033 |
643 |
627 |
420 |
719 |
544 |
|
SD |
113 |
25 |
202 |
120 |
27 |
24 |
74 |
26 |
123 |
41 |
Applicant's summary and conclusion
- Conclusions:
- From the above findings from a study conducted according to OECD guideline 471 (1983) it is concluded that Epsilon-Trifluoracetyl-L-lysyl-L-prolin did not show mutagenic activity in Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 either in the absence or in the presence of the S-9 mix, under the conditions employed in this evaluation. Thus, the test item does not need to be classified as mutagenic according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
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