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EC number: 215-355-9 | CAS number: 1323-42-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Envigo, Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD UK
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid
- Details on test material:
- Physical state/Appearance: Off-white solid
Batch: 0000149116
Purity: >80%
Expiry Date: 28 October 2017
Storage Conditions: Room temperature in the dark
Constituent 1
Method
- Target gene:
- his
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 metabolic fraction, 10%
- Test concentrations with justification for top dose:
- Eight concentrations of the test item (1.5, 5, 15, 50, 150, 500, 1500 and 5000 microgram/plate) were assayed in triplicate against each tester strain, using the direct plate incorporation method.
- Vehicle / solvent:
- Tetrahydrofuran
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other:
- Details on test system and experimental conditions:
- Top agar was prepared using 0.6% Bacto agar (lot number 6147883 03/21) and 0.5% sodium chloride with 5 mL of 1.0 mM histidine and 1.0 mM biotin or 1.0 mM tryptophan solution added to each 100 mL of top agar.
In this assay, overnight sub-cultures of the appropriate coded stock cultures were prepared in nutrient broth (Oxoid Limited; lot number 1865318 05/21) and incubated at 37 °C for approximately 10 hours.
Both plate incorporation method and pre-incubation methods were used in this study.
All of the plates were incubated at 37 ± 3 degrees C for approximately 48 hours and scored for the presence of revertant colonies using an automated colony counting system. The plates were viewed microscopically for evidence of thinning (toxicity). - Evaluation criteria:
- The criteria for determining a positive result include any, one, or all of the following:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out of historical range response (Cariello and Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium 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:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- A test item precipitate (white and particulate in appearance) was noted at and above 500 μg/plate, this observation did not prevent the scoring of revertant colonies.
There were no toxicologically significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 1 (plate incorporation method) or in Experiment 2 (preincubation method).
A small, statistically significant increase in TA98 revertant colony frequency was observed in the absence of S9-mix at 500 µg/plate in the first mutation test. This increase was considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant colony counts at 500 µg/plate were within the in-house historical untreated/vehicle control range for the tester strain and the fold increase was only 1.4 times the concurrent vehicle control.
Any other information on results incl. tables
Experiment 1- Without metabolic activation (Plate Incorporation)
Test Period |
From: 10 March 2017- 16 March 2017 |
To: 13 March 2017- 19 March 2017 |
||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||
Base-Pair substitution strains |
Frameshift strains |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
Solvent Control (THF) |
120 101 (113) 118 10.4# |
14 15 (13) 10 2.6 |
38 41 (38) 34 3.5 |
24 23 (27) 35 6.7 |
21 12 (15) 12 5.2 |
|
1.5μg |
127 117 (123) 125 5.3 |
23 14 (17) 13 5.5 |
37 48 (44) 48 6.4 |
23 31 (31) 40 8.5 |
15 9 (14) 18 4.6 |
|
5μg |
125 118 (117) 108 8.5 |
12 18 (15) 15 3.0 |
43 45 (42) 38 3.6 |
35 33 (34) 35 3.5 |
11 17 (14) 15 3.1 |
|
15μg |
111 110 (115) 123 7.2 |
23 17 (19) 16 3.8 |
40 37 (35) 29 5.7 |
34 34 (36) 40 3.5 |
22 15 (17) 14 4.4 |
|
50μg |
110 125 (124) 137 13.7 |
8 9 (9) 10 1.0 |
46 31 (38) 37 7.5 |
35 32 (33) 33 1.5 |
12 12 (14) 19 4.0 |
|
150μg |
116 114 (120) 130 8.7 |
17 14 (14) 12 2.5 |
33 39 (36) 37 3.1 |
30 40 (34) 33 5.1 |
21 13 (17) 17 4.0 |
|
500μg |
137P 122P (124) 112P 13.5 |
13P 14P (14) 16P 1.5 |
46 P 34 P (36) 28 P 3.1 |
39P * 39P (38) 36P 4.2 |
20P 15P (17) 17P 2.5 |
|
1500μg |
115P 129P (123) 126P 7.4 |
10P 10P (10) 10P 0.0 |
32 P 24 P (36) 31 P 9.2 |
37P 31P (36) 39P 1.7 |
15P 12P (14) 14P 1.5 |
|
5000μg |
116P 113P (110) 101P 7.9 |
13P 11P (12) 11p 1.2 |
30 P 14 P (26) 33 P 10.2 |
37P 31P (34) 31P 4.6 |
12P 15P (11) 7P 4.0 |
|
Positive controls S9- Mix (-) |
Name Dose Level No. of Revertants |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
3μg |
5μg |
2μg |
0.2μg |
80μg |
||
562 580 (594) 640 40.8 |
361 430 (396) 397 34.5 |
972 1028 (997) 992 28.4 |
108 110 (114) 124 8.7 |
211 295 (274) 315 55.2 |
( ) concurrent negative controls
# standard deviation
* P </= 0.05
Experiment 1- With Metabolic Activation (Plate Incorporation)
Test Period |
From: 10 March 2017- 16 March 2017 |
To: 13 March 2017- 19 March 2017 |
||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||
Base-Pair substitution strains |
Frameshift strains |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
Solvent Control (THF) |
114 116 (113) 109 3.6# |
12 10 (12) 15 2.5 |
33 32 (34) 37 2.6 |
23 23 (25) 28 2.9 |
9 18 (14) 14 4.5 |
|
1.5μg |
99 99 (104) 113 8.1 |
7 13 (10) 11 3.1 |
35 42 (35) 28 7.0 |
39 29 (32) 29 5.8 |
14 10 (13) 14 4.5 |
|
5μg |
103 106 (106) 110 3.5 |
11 11 (11) 12 0.6 |
28 27 (31) 37 5.5 |
28 23 (25) 25 2.5 |
14 8 (11) 12 3.1 |
|
15μg |
107 124 (124) 142 17.5 |
11 12 (10) 8 2.1 |
24 41 (32) 31 8.5 |
33 36 (32) 28 4.0 |
18 15 (15) 11 3.5 |
|
50μg |
121 135 (127) 126 7.1 |
11 12 (12) 13 1.2 |
27 29 (29) 31 2.0 |
21 27 (29) 38 8.6 |
9 18 (14) 16 4.7 |
|
150μg |
132 129 (131) 131 1.5 |
11 19 (14) 12 4.4 |
29 31 (31) 33 2.0 |
21 28 (24) 22 3.8 |
15 14 (14) 13 1.0 |
|
500μg |
115P 118P (119) 125P 5.1 |
19P 12P (11) 10P 1.2 |
37P 31P (33) 32P 3.2 |
18P 32P (30) 39P 10.7 |
15P 11P (13) 12P 2.1 |
|
1500μg |
101P 134P (112) 101P 19.1 |
9P 14P (11) 10P 2.6 |
33P 19P (30) 38P 9.8 |
20P 27P (26) 32P 6.0 |
11P 9P (9) 7P 2.0 |
|
5000μg |
117P 104P (109) 106P 7.0 |
12P 10P (12) 14P 2.0 |
33P 33P (30) 25P 4.6 |
26P 26P (24) 21P 2.9 |
10P 11P (10) 9P 1.0 |
|
Positive controls S9- Mix (-) |
Name Dose Level No. of Revertants |
2AA |
2AA |
2AA |
BP |
2AA |
1μg |
2μg |
10μg |
5μg |
2μg |
||
1940 1883 (1850) 1727 110.3 |
289 264 (264) 240 24.5 |
271 374 (347) 395 66.4 |
225 199 (217) 228 15.9 |
402 396 (416) 451 30.2 |
( ) Concurrent negative controls
# Standard deviation
P Precipitate
Experiment 2- Without metabolic activation (Pre-Incubation)
Test Period |
From: 24 March |
To: 27 March |
||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||
Base-Pair substitution strains |
Frameshift strains |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
Solvent Control (THF) |
91 92 (89) 85 3.8# |
14 9 (11) 11 2.5 |
35 37 (38) 43 4.2 |
13 21 (18) 20 4.4 |
8 13 (10) 8 2.9 |
|
15μg |
89 86 (92) 102 8.5 |
8 8 (8) 9 0.6 |
32 28 (32) 36 4.0 |
15 21 (16) 12 4.6 |
4 8 (8) 11 3.5 |
|
50μg |
83 78 (79) 73 4.0 |
8 10 (9) 9 1.0 |
33 42 (40) 44 5.9 |
18 14 (17) 19 2.6 |
11 5 (8) 8 3.0 |
|
150μg |
83 88 (85) 85 2.5 |
9 9 (9) 8 0.6 |
40 36 (39) 41 2.6 |
21 22 (21) 19 15 |
8 10 (8) 7 1.5 |
|
500μg |
101P 86P (93) 92P 7.5 |
14P 10P (12) 11P 2.1 |
40P 33P (37) 37P 3.5 |
16P 19P (20) 25P 4.6 |
12P 7P (9) 9P 2.5 |
|
1500μg |
88P 96P (90) 86P 5.3 |
10P 12P (11) 11P 1.0 |
40P 35P (39) 42P 3.6 |
21P 19P (19) 17P 2.0 |
13P 11P (11) 8P 2.5 |
|
5000μg |
94P 79P (88) 90P 7.8 |
9P 12P (10) 9P 1.7 |
34P 37P (34) 30P 3.5 |
21P 19P (21) 22P 1.5 |
10P 7P (10) 12P 2.5 |
|
Positive controls S9- Mix (-) |
Name Dose Level No. of Revertants |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
3μg |
5μg |
2μg |
0.2μg |
80μg |
||
511 542 (547) 588 38.7 |
193 190 (192) 193 1.7 |
283 248 (269) 276 18.5 |
190 191 (191) 192 1.0 |
387 213 (274) 223 97.7 |
( ) concurrent negative controls
# Standard deviation
P Precipitate
Experiment 2- With Metabolic Activation (Pre-Incubation)
Test Period |
From: 24 March |
To: 27 March |
||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||
Base-Pair substitution strains |
Frameshift strains |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
Solvent Control (THF) |
96 95 (96) 98 1.5# |
7 12 (12) 17 5.0 |
47 37 (37) 27 10.0 |
40 27 (28) 17 11.5 |
9 9 (8) 7 1.2 |
|
15μg |
103 104 (103) 103 0.6 |
16 9 (13) 14 3.6 |
38 38 (38) 38 0.0 |
26 18 (28) 40 11.1 |
9 5 (9) 13 4.0 |
|
50μg |
84 92 (89) 92 4.6 |
9 10 (11) 14 2.6 |
39 31 (36) 37 4.2 |
28 17 (24) 28 6.4 |
3 9 (7) 8 3.2 |
|
150μg |
91 97 (94) 93 3.1 |
15 7 (12) 14 4.4 |
47 34 (42) 44 6.8 |
20 22 (24) 28 6.4 |
15 9 (10) 7 4.2 |
|
500μg |
97P 91P (92) 88P 4.6 |
10P 12P (12) 14P 2.0 |
34P 45P (39) 39P 5.5 |
27P 30P (29) 30P 1.7 |
12P 8P (9) 7P 2.6 |
|
1500μg |
101P 95P (96) 91P 5.0 |
11P 10P (11) 13P 1.5 |
36P 44P (40) 41P 4.0 |
29P 26P (26) 24P 2.5 |
10P 6P (9) 11P 2.6 |
|
5000μg |
90P 97P (93) 93P 3.5 |
14P 12P (12) 11P 1.5 |
32P 39P (37) 41P 4.7 |
22P 23P (25) 29P 3.8 |
10P 9P (9) 7P 1.5 |
|
Positive controls S9- Mix (-) |
Name Dose Level No. of Revertants |
2AA |
2AA |
2AA |
BP |
2AA |
1μg |
2μg |
10μg |
5μg |
2μg |
||
1785 1819 (1725) 1570 135.0 |
270 276 (272) 270 3.5 |
257 209 (238) 248 25.5 |
120 108 (116) 120 6.9 |
248 271 (264) 272 13.6 |
( ) Concurrent negative controls
# Standard deviation
P Precipitate
Applicant's summary and conclusion
- Conclusions:
- Naturechem® GMHS (Glyceryl Monohydroxystearate) was non-mutagenic in the Ames Assay under the conditions of this test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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