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EC number: 700-825-2 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2012-05-16 to 2012-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction products of 12-hydroxyoctadecanoic acid with ethane-1,2-diamine and hexane-1,6-diamine and 1,3-phenylenedimethanamine
- EC Number:
- 700-825-2
- Molecular formula:
- Not applicable (UVCB substance).
- IUPAC Name:
- Reaction products of 12-hydroxyoctadecanoic acid with ethane-1,2-diamine and hexane-1,6-diamine and 1,3-phenylenedimethanamine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- - First mutagenicity experiment with and without S9 mix: 62.5, 125, 250, 500 and 1000µg/plate
- Second mutagenicity experiment with and without S9 mix: 62.5, 125, 250, 500 and 1000µg/plate. - Vehicle / solvent:
- - Vehicle used: dimethylsulfoxide
- Justification for choice: test item was soluble in the vehicle at 100 mg/mL
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar.
The test item was tested in a preliminary test and two mutagenicity experiments.
The preliminary test, both experiments without S9 mix and the first experiment with S9 mix were performed according to the direct plate
incorporation method. The second experiment with S9 mix was performed according to the preincubation method.
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 or 72 hours.
SELECTION AGENT (mutation assays):
- Agar containing traces of histidine and biotin, maintained at 45°C for Salmonella strains.
NUMBER OF REPLICATIONS
- Two independent mutagenicity experiments each using three plates/dose-level
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertant colonies and/or thinning of the bacterial lawn. - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account.
- Statistics:
- No statistical analysis performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Tested up to limit concentrations recommended by the test guideline
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Tested up to limit concentrations recommended by the test guideline
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
- The number of revertants for the vehicle and positive controls were as specified in the acceptance criteria. The study was therefore considered as valid.
- Since the test item was found poorly soluble and non-cytotoxic in the preliminary test, the choice of the highest dose-level was based on the level of precipitate, according to the criteria specified in the international guidelines.
- A moderate to strong precipitate was observed at dose-levels > or = to 125 µg/plate, this did not prevent the scoring of revertant colonies.
- No toxicity was noted at any dose-level in any strain.
- The test item did not induce any noteworthy increase in the number of revertants, in any of the strains, either with or without S9 mix.
Table 7.6.1/1 Experiment 1- Without metabolic activation
Strain |
Compound |
Dose-level (µg/plate) |
With or without S9 mix |
Number of revertant per plate |
Mean revertant colony count (SD) |
TA1535 |
DMSO |
|
- |
16-20-17 |
18 (2) |
TEST ITEM |
62.5 |
- |
19-17-24 |
20 (4) |
|
125 |
- |
17-13-14 |
15 (2) |
||
250 |
- |
10Mp-26Mp-16Mp |
17 (8) |
||
500 |
- |
23Mp-17Mp-16Mp |
19 (4) |
||
1000 |
- |
14Sp-17Sp-19Sp |
17 (3) |
||
NAN3 |
1 |
- |
761-623-614 |
666 (82) |
|
TA1537 |
DMSO |
|
- |
11-6-5 |
7 (3) |
TEST ITEM |
62.5 |
- |
11-7-8 |
9 (2) |
|
125 |
- |
18Mp-11Mp-8Mp |
12 (5) |
||
250 |
- |
8Mp-7Mp-6Mp |
7 (1) |
||
500 |
- |
14Mp-10Mp-7Mp |
10 (4) |
||
1000 |
- |
4Sp-7Sp-4Sp |
5 (2) |
||
9 AA |
50 |
- |
404-242-362 |
336 (84) |
|
TA 98 |
DMSO |
|
- |
14-20-28 |
21 (7) |
TEST ITEM |
62.5 |
- |
22-16-14 |
17 (4) |
|
125 |
- |
23Mp-32Mp-25Mp |
27 (5) |
||
250 |
- |
18Mp-16Mp-16Mp |
17 (1) |
||
500 |
- |
16Mp-13Mp-18Mp |
16 (3) |
||
1000 |
- |
12Sp-12Sp-6Sp |
10 (3) |
||
2 NF |
0.5 |
- |
116-116-84 |
105 (18) |
|
TA 100 |
DMSO |
|
- |
117-153-127 |
132 (19) |
TEST ITEM |
62.5 |
- |
128-119-145 |
131 (13) |
|
125 |
- |
198Mp-131Mp-149Mp |
159 (35) |
||
250 |
- |
164Mp-144Mp-138Mp |
149 (14) |
||
500 |
- |
162Mp-159Mp-125Mp |
149 (21) |
||
1000 |
- |
90Sp-134Sp-110Sp |
111 (22) |
||
NAN3 |
1 |
- |
429-515-563 |
502 (68) |
|
TA102 |
DMSO |
|
- |
269-369-347 |
328 (53) |
TEST ITEM |
62.5 |
- |
358-309-320 |
329 (26) |
|
125 |
- |
338Mp-307Mp-332Mp |
326 (16) |
||
250 |
- |
302Mp-340Mp-311Mp |
318 (20) |
||
500 |
- |
388Mp-398Mp-325Mp |
370 (40) |
||
1000 |
- |
305Sp-364Sp-374Sp |
348 (37) |
||
MMC |
0.5 |
- |
1872-1804-1820 |
1832 (36) |
Table 7.6.1/2 Experiment 1- With metabolic activation
Strain |
Compound |
Dose-level (µg/plate) |
With or without S9 mix |
Number of revertant per plate |
Mean revertant colony count (SD) |
TA1535 |
DMSO |
|
+ |
23-26-23 |
24 (2) |
TEST ITEM |
62.5 |
+ |
22-13-23 |
19 (6) |
|
125 |
+ |
25Mp-22mp-17mp |
21 (4) |
||
250 |
+ |
31Mp-25Mp-17Mp |
24 (7) |
||
500 |
+ |
19Mp-35Mp-20Mp |
25 (9) |
||
1000 |
+ |
20Sp-28Sp-30Sp |
26 (5) |
||
2 AM |
2 |
+ |
246-268-253 |
256 (11) |
|
TA1537 |
DMSO |
|
+ |
6-12-4 |
7 (4) |
TEST ITEM |
62.5 |
+ |
6-5-4 |
5 (1) |
|
125 |
+ |
4Mp-10Mp-12Mp |
9 (4) |
||
250 |
+ |
16Mp-16Mp-8Mp |
13 (5) |
||
500 |
+ |
8Mp-22Mp-10Mp |
13 (8) |
||
1000 |
+ |
8Sp-8Sp-1Sp |
6 (4) |
||
2 AM |
2 |
+ |
195-182-205 |
194 (12) |
|
TA 98 |
DMSO |
|
+ |
14-20-28 |
19(3) |
TEST ITEM |
62.5 |
+ |
22-16-18 |
24 (7) |
|
125 |
+ |
23Mp-32Mp-25Mp |
29 (7) |
||
250 |
+ |
18Mp-16Mp-16MP |
23 (1) |
||
500 |
+ |
16Mp-13Mp-18MP |
29 (10) |
||
1000 |
+ |
12sp-12Sp-6Sp |
15 (8) |
||
2 AM |
2 |
+ |
116-116-84 |
1353 (54) |
|
TA 100 |
DMSO |
|
+ |
165-135-126 |
142 (20) |
TEST ITEM |
62.5 |
+ |
151-145-141 |
146 (5) |
|
125 |
+ |
129Mp-156Mp-149Mp |
145 (14) |
||
250 |
+ |
125Mp-131Mp-137Mp |
131 (6) |
||
500 |
+ |
131Mp-113Mp-133Mp |
126 (11) |
||
1000 |
+ |
103Sp-104Sp-99Sp |
102 (3) |
||
BAP |
5 |
+ |
704-473-440 |
539 (144) |
|
TA102 |
DMSO |
|
+ |
467-534-519 |
507 (35) |
TEST ITEM |
62.5 |
+ |
399-493-381 |
424 (60) |
|
125 |
+ |
556Mp-466mp-419Mp |
480 (70) |
||
250 |
+ |
501Mp-381Mp-453Mp |
445 (60) |
||
500 |
+ |
344Mp-389Mp-331Mp |
355 (30) |
||
1000 |
+ |
301Sp-293Sp-328Sp |
307 (18) |
||
2 AM |
10 |
+ |
3477-4079-4423 |
3993 (479) |
Table 7.6.1/3 Experiment 2- Without metabolic activation
Strain |
Compound |
Dose-level (µg/plate) |
With or without S9 mix |
Number of revertant per plate |
Mean revertant colony count (SD) |
TA1535 |
DMSO |
|
- |
10-12-16 |
13 (3) |
TEST ITEM |
62.5 |
- |
17-24-16 |
19 (4) |
|
125 |
- |
16-19-19 |
18 (2) |
||
250 |
- |
14Mp-13Mp-16Mp |
14 (2) |
||
500 |
- |
5Mp-14Mp-19Mp |
13 (7) |
||
1000 |
- |
18Sp-25Sp-18Sp |
20 (4) |
||
NAN3 |
1 |
- |
719-752-733 |
735 (17) |
|
TA1537 |
DMSO |
|
- |
12-5-16 |
11 (6) |
TEST ITEM |
62.5 |
- |
22-16-24 |
21 (4) |
|
125 |
- |
12Mp-20Mp-29Mp |
20 (9) |
||
250 |
- |
22Mp-16Mp-18Mp |
19 (3) |
||
500 |
- |
25Mp-12Mp-20Mp |
19 (7) |
||
1000 |
- |
13Sp-16Sp-16Sp |
15 (2) |
||
9 AA |
50 |
- |
166-187-141 |
165 (23) |
|
TA 98 |
DMSO |
|
- |
20-17-23 |
20 (3) |
TEST ITEM |
62.5 |
- |
16-12-16 |
15 (2) |
|
125 |
- |
20Mp-25Mp-17Mp |
21 (4) |
||
250 |
- |
20Mp-20Mp-22Mp |
21 (1) |
||
500 |
- |
20Mp-32Mp-18Mp |
23 (8) |
||
1000 |
- |
23Sp-16sp-20Sp |
20 (4) |
||
2 NF |
0.5 |
- |
139-134-104 |
126 (19) |
|
TA 100 |
DMSO |
|
- |
137-156-149 |
147 (10) |
TEST ITEM |
62.5 |
- |
140-163-149 |
151 (12) |
|
125 |
- |
186Mp-153Mp-157Mp |
165 (18) |
||
250 |
- |
158Mp-171Mp-144Mp |
158 (14) |
||
500 |
- |
149Mp-190Mp-162Mp |
167 (21) |
||
1000 |
- |
147Sp-159Sp-174Sp |
160 (14) |
||
NAN3 |
1 |
- |
507-502-450 |
486 (32) |
|
TA102 |
DMSO |
|
- |
313-315-357 |
328 (25) |
TEST ITEM |
62.5 |
- |
335-390-335 |
353 (32) |
|
125 |
- |
320Mp-304Mp-285Mp |
303 (18) |
||
250 |
- |
353Mp-335Mp-343Mp |
34 (9) |
||
500 |
- |
299Mp-343Mp-357Mp |
333 (30) |
||
1000 |
- |
346Sp-296Sp-316Sp |
319 (25) |
||
MMC |
0.5 |
- |
1423-1850-1871 |
1715 (253) |
Table 7.6.1/4 Experiment 2- With metabolic activation
Strain |
Compound |
Dose-level (µg/plate) |
With or without S9 mix |
Number of revertant per plate |
Mean revertant colony count (SD) |
TA1535 |
DMSO |
|
+ |
20-29-23 |
24 (5) |
TEST ITEM |
62.5 |
+ |
20-25-24 |
23 (3) |
|
125 |
+ |
23Mp-28Mp-23Mp |
25 (3) |
||
250 |
+ |
18Mp-23Mp-31Mp |
24 (7) |
||
500 |
+ |
26Mp-28Mp-19Mp |
24 (5) |
||
1000 |
+ |
26Sp-22Sp-18Sp |
22 (4) |
||
2 AM |
2 |
+ |
719-752-733 |
176 (27) |
|
TA1537 |
DMSO |
|
+ |
12-11-11 |
11 (1) |
TEST ITEM |
62.5 |
+ |
22-16-24 |
25 (5) |
|
125 |
+ |
12Mp-20Mp-29Mp |
16 (2) |
||
250 |
+ |
22Mp-16Mp-18Mp |
16 (4) |
||
500 |
+ |
25Mp-12Mp-20Mp |
14 (4) |
||
1000 |
+ |
13Sp-16Sp-16Sp |
19 (5) |
||
2 AM |
2 |
+ |
166-187-141 |
192 (22) |
|
TA 98 |
DMSO |
|
+ |
29-23-29 |
27 (3) |
TEST ITEM |
62.5 |
+ |
34-29-31 |
31 (3) |
|
125 |
+ |
30Mp-40Mp-35Mp |
35 (5) |
||
250 |
+ |
30Mp-34Mp-46Mp |
37(8) |
||
500 |
+ |
29Mp-40Mp-28Mp |
32 (7) |
||
1000 |
+ |
23Sp-16Sp-20Sp |
25 (4) |
||
2 AM |
2 |
+ |
1011-950-1016 |
992 (37) |
|
TA 100 |
DMSO |
|
+ |
180-99-135 |
138 (41) |
TEST ITEM |
62.5 |
+ |
139-140-147 |
142 (4) |
|
125 |
+ |
140Mp-159Mp-141Mp |
147 (11) |
||
250 |
+ |
160Mp-171Mp-133Mp |
155 (20) |
||
500 |
+ |
164Mp-164Mp-134Mp |
154 (17) |
||
1000 |
+ |
145Sp-138Sp-133Sp |
139 (6) |
||
BAP |
5 |
+ |
366-496-572 |
478 (104) |
|
TA102 |
DMSO |
|
+ |
315-438-514 |
422 (100) |
TEST ITEM |
62.5 |
+ |
386-335-390 |
370 (31) |
|
125 |
+ |
523mp-519Mp-466Mp |
503 (32) |
||
250 |
+ |
335Mp-332Mp-394Mp |
354 (35) |
||
500 |
+ |
411Mp-352Mp-376Mp |
380 (30) |
||
1000 |
+ |
361Sp-340Sp-331Sp |
344 (15) |
||
2 AM |
10 |
+ |
1484-1460-1310 |
1418 (94) |
NAN3: Sodium azide
BAP: Benzo(a)pyrene
9AA: 9 -Aminoacridine
2NF: 2 -nitrofluorene
MMC: Mitomycine C
2AM: 2 -anthramine
Mp: Moderate precipitate
Sp: Strong precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium, either in the presence or in the absence of a rat liver metabolizing system. - Executive summary:
The potential of the substance to induce reverse mutation in bacteria was assessed using five strains of Salmonella typhimurium according to the OECD guideline 471.The study was conducted in compliance with Good Laboratory Practices.
A preliminary toxicity test was performed to define the dose-levels of the test substance to be used for the mutagenicity study. The test item ( suspended in dimethylsulfoxide) was then tested in two independent experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation.After 48 -72 hours of incubation at 37°C, the revertant colonies were scored. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
Since the test item was found poorly soluble and non-cytotoxic in the preliminary test, the choice of the highest dose-level was based on the level of precipitate, according to the criteria specified in the international guidelines. The selected treatment-levels were 62.5, 125, 250, 500 and 1000 µg/plate for the five strains used in both mutagenicity experiments.
In the main experiment, the number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
A moderate to strong precipitate was observed in the petri plates at dose-levels equal or higher than 125 µg/plate. No noteworthy toxicity was noted at any dose-levels towards the five strains used, either with or without S9 mix.
In the two independent assays, no significant increase in the mean number of revertants was noted in the bacterial strains tested in the presence of the test substance neither with nor without metabolic activation.
Under these experimental conditions,the substance did not show any mutagenic activity in the bacterial reverse mutation test.
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