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EC number: 943-381-7 | CAS number: 2156594-85-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- 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:
- 2014-11-26 to 2015-05-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed and well documented Guideline study performed under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Validity criteria were taken from the literature and DIN-guideline 38415 part 4 since in OECD and EC guideline no validity criteria are described.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- A post-mitochondrial (S9) fraction from livers of male Wistar rats, which received triple treatments of 80 mg/kg body weight Phenobarbital and -Naphtoflavone orally on consecutive days.
- Test concentrations with justification for top dose:
- Test strain [mg/plate]
1st study (plate incorporation method)
TA 1537 ± S9, TA 98 - S9, TA 100 ± S9, TA 1535 - S9 0.160 – 0.050 – 0.016 – 0.0050 – 0.0016
TA 98 + S9, TA 1535 + S9, E. coli WP2 ± S9 0.500 – 0.160 – 0.050 – 0.016 – 0.0050
2nd study (preincubation method)
TA 98 + S9, E. coli WP2 ± S9 0.500 – 0.23 – 0.050 – 0.023 – 0.0050
TA 1535 + S9 0.500 – 0.23 – 0.050 – 0.023 – 0.0050– 0.0023 – 0.00050 – 0.00023
TA 98 - S9, TA 100 + S9, TA 1537 + S9 0.23 – 0.050 – 0.023 – 0.0050 – 0.0023
TA 100 - S9, TA 1535 - S9, TA 1537 - S9 0.023 – 0.0050 – 0.0023 – 0.00050 – 0.00023 - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Remarks:
- double distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-o-phenylen-diamine; Nitroflurantoine; 2-Aminoanthracen
- Details on test system and experimental conditions:
- Test organism Salmonella typhimurium strains
TA 1537 (not specified),
TA 98 (lot number: 4873D),
TA 100 (lot number: 4846D),
TA 1535 (lot number: 4308D) and
Escherichia coli WP2 (trp, uvrA, pKM101) (lot number: 4854D) with (+) and without (-) metabolic activation system (S9)
Reason for the selection Strains are selected according to the guidelines.
of the test system
Origin TRINOVA BIOCHEM GMBH, Kerkrader Straße 10, D-35394 Gießen
The Salmonella typhimurium lyophilized disc cultures were prepared from master cultures obtained from Dr. Bruce N. Ames, University of California, US.
The Escherichia coli lyophilized disc culture was obtained from the The National Collections of Industrial and Marine Bacteria, Aberdeen, UK.
Storage at test facility Refrigerator, 6 ± 2 °C (TA 98, TA 100, Escherichia coli WP2 (trp, uvrA, pKM101)
Under liquid nitrogen (TA 1537, TA 1535)
Inoculum An overnight culture was prepared. Incubation was performed for 18 ± 2 hours at 37 °C. Titer of the overnight culture must be more than 100000000 cells/mL. - Evaluation criteria:
- Since a reduced background lawn is regarded to be a cytotoxic
effect, plates with reduced background lawn normally were not included into evaluation procedures.
Arithmetic mean values and standard deviations were calculated out of colonies per plate of three replicates.
For evaluation of the results the induction rate of the mean
values were calculated:
The test item is to be classified mutagenic if there is a concentration effect relationship over at least three concentrations and/or the induction rate is more than 2. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Validity Criteria
• The genotypes of the tested strains have been confirmed:
- Histidine- and tryptophan auxotrophy, respectively
- Ampicillin resistance
- UV-sensitivity
- growth inhibition with crystal violet (rfa-mutation)
• Titer of the overnight cultures was > 100000000 cells/mL.
• Spontaneous mutation rates (negative controls) met the requirements. For TA 100 (with and without S9 in DMSO and double distilled water, 2nd study) and TA 1535 (without S9 in DMSO, 1st study) the spontaneous mutation rate was higher than the requested range. This deviation was considered to have no impact on quality and integrity of the study.
• The induction rates of the positive controls were > 2. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
In this study Fatty acids, C18-unsatd., compd. with 2-propanol, 1,1’-iminobis, N-C12-18-(even numbered) alkyl derivs. was found to have no mutagenic effects on Salmonella typhimurium strains TA 1537, TA 98, TA 100, TA 1535 and Escherichia coli WP2 (uvrA) with (+) and without (-) the metabolic activation system S9 from male Wistar rats. - Executive summary:
The mutagenic effects of the test item Fatty acids, C18-unsatd., compd. with 2-propanol, 1,1’-iminobis, N-C12-18-(even numbered) alkyl derivs.(batch number: DEG4273438) were determined in a bacterial reverse mutation test according to OECD Guideline No. 471 for Testing of Chemicals (1997) / Directive 2000/32/EC Method B. 13/14 (2000) in two independent studies (plate incorporation method and preincubation method). Test systems were the Salmonella typhimurium strains TA 1537, TA 98, TA 100 and TA 1535 and Escherichia coli WP2 (uvrA) with (+) and without (-) the metabolic activation system S9 (from male Wistar rats), respectively. Positive and negative controls were included in each study. The test item was dissolved in DMSO and applied once at the start of the exposure with the concentration ranges as given in the Table. Duration of each study was 48 hours. Mutagenic and cytotoxic effects are summarized in the Table.
Table: Mutagenic and Cytotoxic Effects of the Test Item
Strain
S9
Tested Concentration Range
[mg/plate]
Lowest Mutagenic Concentration
[mg/plate]
Lowest Cytotoxic Concentration
[mg/plate]1ststudy
factorÖ10
2ndstudy
factorÖ5
1ststudy
factorÖ10
2ndstudy
factorÖ5
TA 1537
-
0.16 – 0.0016
0.023 – 0.00023
none
0.16
0.023
+
0.16 – 0.0016
0.23 – 0.0023
none
> 0.16
> 0.23
TA 98
-
0.16 – 0.0016
0.23 – 0.0023
none
> 0.16
0.23
+
0.5 – 0.005
0.5 – 0.005
none
> 0.5
> 0.5
TA 100
-
0.16 – 0.0016
0.023 – 0.00023
none
0.16
> 0.023
+
0.16 – 0.0016
0.23 – 0.0023
none
0.16
> 0.23
TA 1535
-
0.16 – 0.006
0.023 – 0.00023
none
> 0.16
0.023
+
0.5 – 0.005
0.5 – 0.00023
none
> 0.5
0.5
E. coliWP2 (uvrA)
-
0.5 – 0.005
0.5 – 0.005
none
> 0.5
> 0.5
+
0.5 – 0.005
0.5 – 0.005
none
> 0.5
> 0.5
Result: The test item is regarded to be not mutagneic under this test conditions.
Reference
Test of the Reference Items
Positive controls were tested parallel to the test item.
Table5: Induction Rates of Reference Items (Positive Controls)
Strain |
Reference item |
[µg/plate] |
S9 |
Induction Rate* |
|
|
|
|
|
1ststudy |
2ndstudy |
TA 1537 |
ICR 191 |
2.0 |
- |
> 111 |
> 51.7 |
|
|
|
|
|
|
2-Aminoanthracene |
2.0 |
+ |
23.2 |
> 273 |
|
TA 98 |
4-Nitro-o-phenylenediamine |
0.5 |
- |
7.0 |
3.3 |
|
|
|
|
|
|
Benzo(a)pyrene |
10 |
+ |
19.8 |
6.4 |
|
TA 100 |
Nitrofurantoine |
0.2 |
- |
2.7 |
2.5 |
|
|
|
|
|
|
2-Aminoanthracene |
2.0 |
+ |
10.5 |
> 4.0 |
|
TA 1535 |
Sodium azide |
0.25 |
- |
3.1 |
4.1 |
|
|
|
|
|
|
2-Aminoanthracene |
2.0 |
+ |
14.9 |
16.4 |
|
E. coliWP2 (uvrA, pKM101) |
4-Nitroquinolin-1-oxid |
1.0 |
- |
> 6.0 |
> 4.6 |
|
|
|
|
|
|
2-Aminoanthracene |
25.0 |
+ |
> 3.1 |
> 4.6 |
Plates with number of colonies higher than 1000 colonies were not counted,
induction rates were calculated with this number and given as > values.
*) Induction Rates were calculated in relation to the double distilled water control
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In this AMES test Fatty acids, C18-unsatd., compd. with 2-propanol, 1,1’-iminobis, N-C12-18-(even numbered) alkyl derivs. was found to have no mutagenic effects on Salmonella typhimurium strains TA 1537, TA 98, TA 100, TA 1535 and Escherichia coli WP2 (uvrA) with (+) and without (-) the metabolic activation system S9 from male Wistar rats.
Justification for selection of genetic toxicity endpoint
Scientifically well performed and well documented Guideline study performed under GLP.
Justification for classification or non-classification
For gentetic toxicity, no classification is warranted for the registration substance according to the OECD GHS criteria.
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