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EC number: 283-393-3 | CAS number: 84608-82-2
- 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:
- 22 - 31 Aug 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
- EC Number:
- 283-393-3
- EC Name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
- Cas Number:
- 84608-82-2
- Molecular formula:
- C26H45NO6
- IUPAC Name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
Constituent 1
Method
- Target gene:
- his operon, trp operon
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 97a, TA 98, TA 100, TA 102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor-supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats, induced with Aroclor 1254 (500 mg/kg bw)
- Test concentrations with justification for top dose:
- Following concentrations were used in the main experiments:
First experiment (plate incorporation, all strains): 0.05, 0.15, 0.5, 1.5, 5 μL/plate with and without metabolic activation (tested up to the limit concentration)
Second experiment (preincubation, all strains): 0.16, 0.31, 0.63, 1.25, 2.5, 5 μL/plate with and without metabolic activation (tested up to the limit concentration) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO was selected because of the sufficient solubility of the test substance in DMSO and no effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
Controls
- Untreated negative controls:
- yes
- Remarks:
- demineralised water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-nitro-1,2-phenylene diamine (4NPD), 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation (first experiment); preincubation (second experiment)
DURATION
- Preincubation period: 20 min
- Exposure duration: approx. 48 h
NUMBER OF REPLICATIONS: triplicates in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of bacterial background lawn and number of revertant colonies - Evaluation criteria:
- Acceptance criteria
The study was considered valid if:
- the number of revertant colonies of the negative (solvent) and positive controls are in the historical control range
- all tester strain cultures are at least 10^9 bacteria/mL
- no contamination (inconsistency in sterility control)
- positive control chemicals (diagnostic mutagens) show mutagenic effects
Evaluation criteria
A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor (mean revertants divided by mean spontaneous revertants) of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity. - Statistics:
- No information provided about which statistical methods were used.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation was observed in all strains starting at a concentration of 1.5 μL/plate in the first experiment and starting at 2.5 μL/plate in the second experiment. The precipitates on the plates did not influence the counting of bacteria colonies.
- Other confounding effects: Sterility control was negative. It was performed analogously to the test with solvent only and S9 (without adding bacteria) on top agar, incubation for 48 h at 37 ±1°C, using four replicates.
HISTORICAL CONTROL DATA
see Table 3 in "any other information on results incl. tables"
Any other information on results incl. tables
Table 1: Test results (experiment 1, plate incorporation)
With or without S9 Mix |
Test substance concentration (μL/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
Frameshift type |
Base-pair substitution type |
|||||
TA 97 |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
||
– |
Negative control (demin. water) |
95 ± 6.7 |
31 ± 2.0 |
76 ± 4.9 |
281 ± 45.5 |
31 ± 5.0 |
Solvent control (DMSO) |
89 ± 4.0 |
35 ± 5.3 |
75 ± 13.5 |
265 ± 29.5 |
33 ± 3.2 |
|
0.05 |
68 ± 13.9 |
29 ± 10.8 |
96 ± 6.6 |
269 ± 16.2 |
30 ± 1.7 |
|
0.15 |
82 ± 11.1 |
33 ± 3.6 |
86 ± 18.3 |
333 ± 47.7 |
32 ± 3.5 |
|
0.5 |
74 ± 9.5 |
33 ± 3.1 |
84 ± 7.0 |
331 ± 59.0 |
25 ± 4.0 |
|
1.5 P |
88 ± 15.3 |
33 ± 2.5 |
89 ± 5.0 |
347 ± 70.5 |
35 ± 5.1 |
|
5 P |
85 ± 7.0 |
35 ± 7.8 |
68 ± 5.7 |
271 ± 45.6 |
27 ± 3.6 |
|
Positive controls (µg/plate) |
4NPD (20) |
4NPD (20) |
SAZ (1) |
4NPD (20) |
SAZ (1) |
|
Mean (No. of colonies/plate) |
643 ± 103.7 |
299 ± 31.1 |
645 ± 25.4 |
691 ± 37.8 |
255 ± 73.8 |
|
+ |
Negative control (demin. water) |
78 ± 12.4 |
36 ± 2.5 |
72 ± 9 |
347 ± 24.1 |
33 ± 3.8 |
Solvent control (DMSO) |
103 ± 18.7 |
36 ± 1.0 |
86 ± 4.0 |
367 ± 37.0 |
32 ± 3.2 |
|
0.05 |
102 ± 23.5 |
30 ± 9.1 |
81 ± 5.5 |
291 ± 35.9 |
31 ± 4.0 |
|
0.15 |
109 ± 12.9 |
33 ± 3.1 |
84 ± 11.1 |
237 ± 34.4 |
30 ± 4.0 |
|
0.5 |
82 ± 14.7 |
33 ± 3.2 |
82 ± 16.8 |
253 ± 44.7 |
32 ± 3.2 |
|
1.5 P |
101 ± 21.9 |
37 ± 4.4 |
81 ± 15.6 |
227 ± 15.3 |
32 ± 2.1 |
|
5 P |
121 ± 16.3 |
39 ± 4.0 |
77 ± 9.6 |
243 ± 88.9 |
29 ± 5.9 |
|
Positive controls (µg/plate) |
2AA (1) |
B(a)P (20) |
2AA (1) |
2AA (1) |
2AA (1) |
|
Mean (No. of colonies/plate) |
361 ± 64.2 |
86 ± 15.3 |
741 ± 108.6 |
1528 ± 116.2 |
196 ± 49.2 |
SAZ = sodium azide
B(a)P = benzo(a)pyrene
4NPD = 4-nitro-1,2-phenylene diamine
2AA = 2-aminoanthracene
P = precipitation
Table 2: Test results (experiment 2, preincubation)
With or without S9 Mix |
Test substance concentration (μL/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
Frameshift type |
Base-pair substitution type |
|||||
TA 97 |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
||
– |
Negative control (demin. water) |
77 ± 4.5 |
43 ± 2.0 |
109 ± 25.5 |
276 ± 30.2 |
12 ± 1.2 |
Solvent control (DMSO) |
88 ± 7.2 |
36 ± 4.4 |
92 ± 8.4 |
264 ± 45.2 |
13 ± 3.1 |
|
0.16 |
89 ± 6.9 |
35 ± 6.6 |
111 ± 13.3 |
272 ± 21.2 |
15 ± 3.6 |
|
0.31 |
78 ± 24.7 |
36 ± 4.5 |
89 ± 18.4 |
265 ± 16.7 |
16 ± 2.9 |
|
0.63 |
82 ± 14.2 |
43 ± 6.4 |
109 ± 6.1 |
229 ± 40.1 |
17 ± 1.0 |
|
1.25 |
79 ± 1.7 |
44 ± 7.0 |
100 ± 10.4 |
199 ± 28.9 |
21 ± 2.0 |
|
2.5 P |
75 ± 10.1 |
47 ± 6.7 |
93 ± 18.2 |
212 ± 21.2 |
13 ± 1.0 |
|
5 P |
83 ± 15.9 |
40 ± 1.2 |
114 ± 21.5 |
255 ± 55.5 |
18 ± 5.0 |
|
Positive controls (µg/plate) |
4NPD (20) |
4NPD (20) |
SAZ (1) |
4NPD (20) |
SAZ (1) |
|
Mean (No. of colonies/plate) |
518 ± 199.5 |
377 ± 116.6 |
352 ± 44.0 |
691 ± 65.2 |
288 ± 34.2 |
|
+ |
Negative control (demin. water) |
80 ± 5.5 |
42 ± 2.1 |
95 ± 11.5 |
225 ± 62.0 |
12 ± 0.6 |
Solvent control (DMSO) |
90 ± 5.5 |
41 ± 2.1 |
95 ± 9.5 |
355 ± 19.7 |
13 ± 3.8 |
|
0.16 |
87 ± 23.0 |
36 ± 1.7 |
115 ± 14.0 |
271 ± 41.6 |
14 ± 2.0 |
|
0.31 |
91 ± 18.6 |
29 ± 5.7 |
120 ± 3.5 |
235 ± 26.0 |
13 ± 3.6 |
|
0.63 |
101 ± 9.5 |
38 ± 6.8 |
104 ± 8.0 |
259 ± 62.1 |
18 ± 3.6 |
|
1.25 |
79 ± 4.5 |
30 ± 4.6 |
100 ± 7.2 |
176 ± 18.3 |
18 ± 2.5 |
|
2.5 P |
89 ± 6.6 |
34 ± 13.1 |
103 ± 19.6 |
205 ± 24.4 |
18 ± 1.0 |
|
5 P |
80 ± 9.3 |
44 ± 17.1 |
115 ± 9.5 |
227 ± 46.0 |
23 ± 4.6 |
|
Positive controls (µg/plate) |
2AA (1) |
B(a)P (20) |
2AA (1) |
2AA (1) |
2AA (1) |
|
Mean (No. of colonies/plate) |
715 ± 176.4 |
148 ± 28.0 |
1001 ± 0.0 |
712 ± 38.6 |
183 ± 23.4 |
SAZ = sodium azide
B(a)P = benzo(a)pyrene
4NPD = 4-nitro-1,2-phenylene diamine
2AA = 2-aminoanthracene
P = precipitation
Table 3: Historical data (negative and positive controls)
Strain |
|
TA 97a |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
|||||
+/- S9 mix |
|
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
H2O demin. |
Min |
60 |
63 |
6 |
8 |
51 |
64 |
85 |
67 |
6 |
7 |
Max |
144 |
138 |
52 |
50 |
141 |
141 |
425 |
511 |
31 |
33 |
|
Mean |
91 |
96 |
16 |
19 |
92 |
97 |
281 |
298 |
17 |
17 |
|
SD |
19 |
16 |
8 |
8 |
16 |
15 |
64 |
74 |
6 |
6 |
|
DMSO |
Min |
58 |
67 |
7 |
8 |
44 |
62 |
79 |
80 |
8 |
6 |
Max |
135 |
144 |
46 |
40 |
136 |
199 |
393 |
459 |
33 |
31 |
|
Mean |
91 |
100 |
16 |
17 |
90 |
92 |
280 |
291 |
17 |
17 |
|
SD |
18 |
17 |
8 |
7 |
17 |
19 |
60 |
65 |
6 |
6 |
|
Positive Controls |
Name |
4NPD |
2-AA |
4NPD |
B(a)P |
SAZ |
2-AA |
4NPD |
2-AA |
SAZ |
2-AA |
Min |
264 |
237 |
100 |
39 |
223 |
273 |
491 |
408 |
55 |
45 |
|
Max |
1152 |
1181 |
793 |
487 |
984 |
1912 |
2331 |
6083 |
484 |
712 |
|
Mean |
553 |
504 |
398 |
93 |
509 |
724 |
1156 |
1232 |
256 |
116 |
|
SD |
167 |
148 |
141 |
74 |
150 |
299 |
446 |
647 |
87 |
77 |
SAZ = sodium azide
B(a)P = benzo(a)pyrene
4NPD = 4-nitro-1,2-phenylene diamine
2AA = 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the conducted study the test substance did not exhibit mutagenic properties in bacterial cells.
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