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EC number: 947-486-9 | CAS number: -
- 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:
- 20 March 2017 to 03 July 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- In accordance with the OECD guideline for testing of chemicals No. 471 “Bacterial Reverse Mutation Test”, adopted on 21st July 1997.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material:Clariant Produkte (Deutschland)
GmbH 84504 Burgkirchen, Germany
- Expiration date of the batch:04.10.2018
- Purity test date:96,9%
STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (21 to 29°C)
- Solubility of the test substance in the solvent/vehicle:Distilled water
Method
- Target gene:
- Hisitidine and tryptophan locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- 1 mL of S9 homogenate was mixed with 9 mL of co-factor
- Test concentrations with justification for top dose:
- The test item was tested at the concentrations of 0.02, 0.06, 0.20, 0.63 and 2 mg/plate based on the results of solubility, precipitation and initial cytotoxicity test.
- Vehicle / solvent:
- Distilled water- Vehicle(s)/solvent(s) used: Distilled water
- Justification for choice of solvent/vehicle:The test item at the given concentration of 50 mg/mL was soluble in distilled at 40 to 45º C
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
- 2-nitrofluorene
- sodium azide
- other: 2-aminoantracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 30 minutes
others: cytotoxicity by lawn evaluation and mutagenicity by evaluating revertant counts.
NUMBER OF REPLICATIONS: Triplicates - Rationale for test conditions:
- not applicable
- Evaluation criteria:
- The test will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value in Salmonella typhimurium strains TA98, TA100 and Escherichia coli WP2 uvrA (pKM101) or equal to or greater than 3 times the mean vehicle control value in tester strains TA1535 and TA1537.vehicle control, in both the trials, in the presence and absence of metabolic activation. There was no appreciable increase in number of revertant colonies at any of the tested concentrations in both the trials.
- Statistics:
- not applicable
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: yes
- Precipitation: minimal precipitation at 2 mg/plate
HISTORICAL CONTROL DATA (with ranges, means and standard deviation)
Plate in corporation method
- Positive historical control data:
Tester strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (With S9)
Mean 408.7 386.1 140.4 118.5 385.5
SD ±16.6 ±13.8 ±8.3 ±6.3 ±5.3
Min 280 306 118 100 370
Max 440 419 182 149 401
Tester strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (Without S9)
Mean 401.5 382.2 141.4 119.8 386.0
SD ±26.3 ±16.5 ±10.6 ±6.5 ±5.8
Min 310 313 112 103 371
Max 428 446 190 158 416
- Negative (solvent/vehicle) historical control data:
Tester strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (With S9)
Mean 20.7 102.5 21.4 9.3 171.8
SD ±1.7 ±2.2 ±2.0 ±1.5 ±5.8
Min 18 98 17 6 159
Max 26 108 25 12 184
Tester strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (Without S9)
Mean 20.9 102.2 21.6 9.3 171.4
SD ±1.8 ±2.6 ±1.9 ±1.5 ±4.9
Min 18 98 18 7 159
Max 25 110 26 13 183
Pre incubation method
- Positive historical control data:
Tester strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (With S9)
Mean 408.0 386.3 140.7 117.9 384.6
SD ±14.5 ±14.2 ±9.8 ±5.2 ±6.3
Min 290 298 103 102 363
Max 429 425 187 128 403
Tester strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (Without S9)
Mean 404.8 383.1 141.9 119.1 385.3
SD ±20.8 ±15.8 ±11.9 ±5.5 ±6.0
Min 314 317 110 105 371
Max 428 450 200 134 418
- Negative (solvent/vehicle) historical control data:
Tester strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (With S9)
Mean 20.6 102.2 22.0 9.5 171.5
SD ±1.5 ±2.5 ±1.9 ±1.4 ±4.5
Min 18 97 18 7 161
Max 24 107 25 12 182
Tester strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (Without S9)
Mean 20.9 102.4 21.5 9.3 170.6
SD ±1.7 ±2.4 ±2.2 ±1.4 ±4.6
Min 18 97 17 7 158
Max 24 110 25 12 181
Any other information on results incl. tables
Table 1: SUMMARY OF INITIAL CYTOTOXICITY TEST-SALMONELLA TYPHIMURIUM TA100
Test Item Concentration (mg/plate) |
No. of Revertants/plate |
|||||||||||
With S9 |
Without S9 |
|||||||||||
R1 |
R2 |
R3 |
Average |
±SD |
Bacterial Lawn Intensity |
R1 |
R2 |
R3 |
Average |
±SD |
Bacterial Lawn Intensity |
|
Vehicle Control |
99 |
87 |
106 |
97 |
9.6 |
4+ |
105 |
112 |
96 |
104 |
8.0 |
4+ |
2 |
102 |
107 |
103 |
104 |
2.6 |
4+ |
110 |
106 |
104 |
107 |
3.1 |
4+ |
1 |
106 |
96 |
102 |
101 |
5.0 |
4+ |
101 |
95 |
89 |
95 |
6.0 |
4+ |
0.9 |
88 |
105 |
101 |
98 |
8.9 |
4+ |
104 |
91 |
97 |
97 |
6.5 |
4+ |
0.8 |
93 |
97 |
84 |
91 |
6.7 |
4+ |
96 |
89 |
104 |
96 |
7.5 |
4+ |
0.7 |
103 |
96 |
91 |
97 |
6.0 |
4+ |
94 |
107 |
97 |
99 |
6.8 |
4+ |
Values of Revertants are in Mean±SD
Lawn intensity: 4+= Thick lawns: Distinguished by a healthy (Normal) background lawn comparable tovehiclecontrol plates.
Table 2: SUMMARY OF COLONY COUNTS OF REVERTANTS OF TRIAL-I, PLATE INCORPORATION METHOD
Treatment |
Test Concentration (mg/plate) |
No. of Revertants (Mean of 3 Plates) |
|||||||||||
With S9 |
|
Without S9 |
|||||||||||
Salmonella typhimurium |
E.coliWP2 uvrA (pKM 101) |
Salmonella typhimurium |
E.coliWP2 uvrA (pKM 101) |
||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
||||||
Vehicle Control |
100 µL of Distilled Water |
Mean |
25.7 |
98.0 |
20.3 |
9.3 |
165.3 |
27.3 |
94.0 |
21.3 |
9.7 |
175.0 |
|
±SD |
5.7 |
9.5 |
3.5 |
4.2 |
7.8 |
1.5 |
9.8 |
2.1 |
1.5 |
10.1 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Hostacerin DGMS |
2 |
Mean |
24.7 |
95.0 |
20.7 |
8.7 |
171.7 |
21.7 |
96.0 |
18.3 |
6.3 |
169.3 |
|
±SD |
4.7 |
7.9 |
2.5 |
1.5 |
7.4 |
3.5 |
8.9 |
3.5 |
2.5 |
11.0 |
|||
Fold Increase |
1.0 |
1.0 |
1.0 |
0.9 |
1.0 |
0.8 |
1.0 |
0.9 |
0.7 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.63 |
Mean |
23.3 |
94.3 |
17.3 |
7.3 |
173.0 |
21.0 |
97.3 |
20.0 |
9.7 |
175.3 |
||
±SD |
5.7 |
11.6 |
2.1 |
2.1 |
13.1 |
4.4 |
4.0 |
3.0 |
2.5 |
7.8 |
|||
Fold Increase |
0.9 |
1.0 |
0.9 |
0.8 |
1.0 |
0.8 |
1.0 |
0.9 |
1.0 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.2 |
Mean |
20.3 |
87.3 |
22.0 |
9.0 |
170.0 |
21.3 |
96.0 |
19.3 |
7.0 |
172.7 |
||
±SD |
4.2 |
8.0 |
1.0 |
2.6 |
4.6 |
4.9 |
15.1 |
3.2 |
2.6 |
9.3 |
|||
Fold Increase |
0.8 |
0.9 |
1.1 |
1.0 |
1.0 |
0.8 |
1.0 |
0.9 |
0.7 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.06 |
Mean |
21.3 |
92.7 |
19.7 |
8.0 |
170.7 |
21.3 |
95.3 |
20.7 |
7.7 |
179.0 |
||
±SD |
2.5 |
7.4 |
4.9 |
3.6 |
5.7 |
6.0 |
9.6 |
3.1 |
1.5 |
1.7 |
|||
Fold Increase |
0.8 |
0.9 |
1.0 |
0.9 |
1.0 |
0.8 |
1.0 |
1.0 |
0.8 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.02 |
Mean |
26.3 |
91.3 |
20.3 |
8.3 |
177.7 |
19.0 |
88.7 |
19.3 |
8.7 |
172.7 |
||
±SD |
4.7 |
9.1 |
1.5 |
4.9 |
6.8 |
3.0 |
5.5 |
4.7 |
3.1 |
6.0 |
|||
Fold Increase |
1.0 |
0.9 |
1.0 |
0.9 |
1.1 |
0.7 |
0.9 |
0.9 |
0.9 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Positive Control |
100 µL of respective Positive Control |
Mean |
353.0 |
335.3 |
133.7 |
130.0 |
360.7 |
357.3 |
351.3 |
132.0 |
120.0 |
361.0 |
|
±SD |
31.1 |
20.5 |
5.0 |
8.0 |
35.3 |
38.5 |
20.4 |
15.1 |
28.4 |
20.7 |
|||
Fold Increase |
13.8 |
3.4 |
6.6 |
13.9 |
2.2 |
13.1 |
3.7 |
6.2 |
12.4 |
2.1 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
Values of Revertants are in Mean±SD
Positive controls:
For with S9:
ForSalmonella typhimuriumTA98, TA100, TA1535 and TA1537 = 4 µg/plate of 2-Aminoanthracene
ForEscherichia coliWP2 uvrA (pKM101)strain +S9 = 30µg/plate of 2-Aminoanthracene
For without S9:
For TA98: 2 µg/plate of 2-Nitrofluorene
For TA100 and TA1535: 1 µg/plate of Sodium azide.
For TA1537: 50 µg/plate of 9-Aminoacridine
ForEscherichia coliWP2 uvrA (pKM101): 5 µg/plate of4-Nitroquinoline 1-oxide
Table 3: SUMMARY OF COLONY COUNTS OF REVERTANTS OF TRIAL-I, PREINCUBATION METHOD
Treatment |
Test Concentration (mg/plate) |
No. of Revertants (Mean of 3 Plates) |
|||||||||||
With S9 |
|
Without S9 |
|||||||||||
Salmonella typhimurium |
E.coliWP2 uvrA (pKM 101) |
Salmonella typhimurium |
E.coliWP2 uvrA (pKM 101) |
||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
||||||
Vehicle Control |
100 µL of Distilled Water |
Mean |
19.7 |
106.0 |
20.0 |
8.0 |
174.3 |
22.7 |
98.3 |
18.7 |
9.3 |
172.3 |
|
±SD |
6.7 |
8.0 |
2.6 |
2.6 |
5.5 |
6.0 |
3.1 |
2.5 |
3.2 |
5.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Hostacerin DGMS |
2 |
Mean |
15.3 |
85.3 |
19.3 |
7.3 |
173.3 |
21.3 |
98.0 |
16.7 |
8.3 |
170.3 |
|
±SD |
1.2 |
11.1 |
0.6 |
4.0 |
12.5 |
3.2 |
9.8 |
1.5 |
5.1 |
1.2 |
|||
Fold Increase |
0.6 |
0.9 |
1.0 |
0.8 |
1.0 |
0.8 |
1.0 |
0.8 |
0.9 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.63 |
Mean |
25.7 |
93.3 |
20.0 |
9.3 |
164.0 |
21.7 |
98.0 |
19.0 |
8.0 |
170.3 |
||
±SD |
2.5 |
4.5 |
4.4 |
1.5 |
6.0 |
5.5 |
3.5 |
4.4 |
3.6 |
11.2 |
|||
Fold Increase |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
0.8 |
1.0 |
0.9 |
0.8 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.2 |
Mean |
17.7 |
93.7 |
19.7 |
8.7 |
167.3 |
22.7 |
97.0 |
17.0 |
11.0 |
169.3 |
||
±SD |
3.1 |
8.1 |
5.1 |
4.2 |
6.1 |
4.7 |
9.8 |
5.3 |
2.0 |
6.5 |
|||
Fold Increase |
0.7 |
1.0 |
1.0 |
0.9 |
1.0 |
0.8 |
1.0 |
0.8 |
1.1 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.06 |
Mean |
18.7 |
101.7 |
19.7 |
10.3 |
171.0 |
20.0 |
86.7 |
20.7 |
9.3 |
168.0 |
||
±SD |
4.2 |
8.7 |
2.5 |
4.7 |
15.7 |
4.4 |
7.1 |
2.5 |
2.1 |
5.3 |
|||
Fold Increase |
0.7 |
1.0 |
1.0 |
1.1 |
1.0 |
0.7 |
0.9 |
1.0 |
1.0 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.02 |
Mean |
15.3 |
94.7 |
16.7 |
7.3 |
169.3 |
19.0 |
89.0 |
16.7 |
8.0 |
166.0 |
||
±SD |
1.2 |
13.3 |
5.5 |
3.1 |
7.4 |
3.6 |
7.2 |
3.1 |
1.7 |
6.2 |
|||
Fold Increase |
0.6 |
1.0 |
0.8 |
0.8 |
1.0 |
0.7 |
0.9 |
0.8 |
0.8 |
0.9 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Positive Control |
100 µL of respective Positive Control |
Mean |
330.3 |
367.7 |
134.3 |
111.0 |
379.0 |
397.3 |
351.7 |
133.7 |
115.7 |
380.0 |
|
±SD |
14.3 |
8.1 |
11.0 |
13.7 |
15.5 |
35.0 |
33.7 |
13.3 |
13.2 |
17.7 |
|||
Fold Increase |
12.9 |
3.8 |
6.6 |
11.9 |
2.3 |
14.5 |
3.7 |
6.3 |
12.0 |
2.2 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
Values of Revertants are in Mean±SD
Positive controls:
For with S9:
ForSalmonella typhimuriumTA98, TA100, TA1535 and TA1537 = 4 µg/plate of 2-Aminoanthracene
ForEscherichia coliWP2 uvrA (pKM101)strain +S9 = 30µg/plate of 2-Aminoanthracene
For without S9:
For TA98: 2 µg/plate of 2-Nitrofluorene
For TA100 and TA1535: 1 µg/plate of Sodium azide.
For TA1537: 50 µg/plate of 9-Aminoacridine
ForEscherichia coliWP2 uvrA (pKM101): 5 µg/plate of4-Nitroquinoline 1-oxide
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, it can be concluded that the registration substance is “non-mutagenic” in the Bacterial Reverse Mutation Test up to the highest tested concentration of 2 mg/plate under the test conditions.
- Executive summary:
The genotoxicity of the registration substance was investigated according to the Guideline OECD 471. No mutagenic activity was observed with and without metabolic activation of the concentration of 2 mg/plate in two independent experiments.
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.