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EC number: 200-735-9 | CAS number: 70-47-3
- 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
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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:
- 2016-10-0 to 2017-01-12
- 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 21st, July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 30th, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Asparagine
- EC Number:
- 200-735-9
- EC Name:
- Asparagine
- Cas Number:
- 70-47-3
- Molecular formula:
- C4H8N2O3
- IUPAC Name:
- asparagine
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- DNA polymerase A deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-NOPD; 4-nitro-o-phenylene-diamine (without metabolic activation), 2-AA; 2-aminoanthracene (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment I: in agar (plate incorporation) and Experiment II: preincubation
- Cell density at seeding (if applicable): 100 µL of Bacteria suspension containing approximately 1E09 cells/mL for both experimental settings
DURATION
- Preincubation period: 60 min in Experiment II
- Exposure duration: 48 h in both experimental settings
NUMBER OF REPLICATIONS: 3 replicates for each strain and dose level, including the controls
DETERMINATION OF CYTOTOXICITY
- Method: other: Cytotoxicity can be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately < 0.5 in relation to the solvent control. - Rationale for test conditions:
- The OECD Guideline for Testing of Chemicals, Section 4, No. 471 — Bacterial Reverse Mutation Test - recommends using a combination of S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102.
- Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- 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.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA, 100, TA 102, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The test item was tested in the pre-experiment with the following concentrations: 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate. The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment. 5000 µg/plate was selected as the maximum concentration. The concentration range covered two logarithmic decades. Two independent experiments were performed with the following concentrations: 31.6, 100, 316, 1000,2500 and 5000 µg/plate.
Any other information on results incl. tables
Table 3:Number of revertants per plate (mean of 3 plates); incorporation method
|
[strain 1535] |
[strain 1537] |
[strain 102] |
[strain 98] |
[strain 100] |
|||||
Conc. |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
0 A dest. |
29 |
15 |
5 |
6 |
270 |
370 |
19 |
28 |
115 |
117 |
0 * |
28 |
14 |
11 |
12 |
261 |
339 |
27 |
28 |
120 |
110 |
31.6 |
29 |
17 |
11 |
10 |
282 |
383 |
18 |
22 |
114 |
113 |
100 |
22 |
12 |
11 |
7 |
275 |
342 |
18 |
17 |
128 |
127 |
316 |
24 |
11 |
10 |
9 |
268 |
307 |
21 |
24 |
116 |
129 |
1000 |
25 |
11 |
11 |
7 |
269 |
313 |
19 |
29 |
112 |
126 |
2500 |
25 |
15 |
9 |
9 |
319 |
308 |
23 |
24 |
98 |
112 |
5000 |
27 |
19 |
9 |
7 |
343 |
401 |
25 |
22 |
110 |
112 |
Positive control [-MA] |
976 |
------ |
68 |
------- |
1470 |
------ |
330 |
--------- |
757 |
------- |
Positive control [+MA] |
------- |
276 |
------- |
356 |
-------- |
925 |
------- |
2405 |
------ |
2142 |
*solvent control with DMSO
Table 4:Number of revertants per plate (mean of 3 plates); preincubation method
|
[strain 1535] |
[strain 1537] |
[strain 102] |
[strain 98] |
[strain 100] |
|||||
Conc. |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
0 A dest. |
7 |
16 |
6 |
9 |
236 |
303 |
19 |
22 |
85 |
108 |
0 * |
8 |
12 |
7 |
7 |
206 |
316 |
22 |
17 |
73 |
95 |
31.6 |
5 |
14 |
5 |
9 |
214 |
295 |
21 |
14 |
69 |
93 |
100 |
8 |
13 |
5 |
6 |
219 |
358 |
20 |
20 |
85 |
93 |
316 |
5 |
13 |
4 |
5 |
247 |
307 |
24 |
19 |
91 |
110 |
1000 |
9 |
11 |
4 |
5 |
267 |
316 |
21 |
16 |
70 |
102 |
2500 |
3 |
16 |
6 |
7 |
252 |
305 |
21 |
25 |
84 |
96 |
5000 |
5 |
13 |
11 |
6 |
256 |
368 |
24 |
22 |
84 |
94 |
Positive control [-MA] |
473 |
------ |
81 |
------- |
1470 |
------ |
321 |
------- |
573 |
------- |
Positive control [+MA] |
------- |
164 |
------- |
226 |
-------- |
677 |
------- |
1751 |
------ |
1238 |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- The present study was conducted according to OECD Test Guideline 471 in order to determine the mutagenicity of L-asparagine. There was no increase in the amount of revertants for each incubation scheme and strain. Therefore, L-asparagine is considered to be non-mutagenic in the bacterial reverse mutation assay.
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