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EC number: 700-768-3 | CAS number: 1285610-71-0
- 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:
- 2011-12-06 - 2012-01-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study in compliance with GLP
Data source
Reference
- Reference Type:
- other: approved draft 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)
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis-[N-C13-(branched and linear)-alykl]-ammonium O,O-dipropan-2-yl phosphorodithioate
- EC Number:
- 700-768-3
- Cas Number:
- 1285610-71-0
- Molecular formula:
- C26H56N.C6H14O2PS2
- IUPAC Name:
- Bis-[N-C13-(branched and linear)-alykl]-ammonium O,O-dipropan-2-yl phosphorodithioate
- Details on test material:
- - Physical state: Liquid, yellowish
- Analytical purity: 98.2 ± 0.4 g/100 g
- Storage condition of test material: Refrigerator
Constituent 1
Method
- Target gene:
- his and trp
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:
- liver S9 mix from induced rats
- Test concentrations with justification for top dose:
- 0.33 μg - 5 500 μg/plate (SPT, Salmonella strains)
33 μg - 5 500 μg/plate (SPT, E. coli)
0.33 μg - 100 μg/plate (PIT, Salmonella strains)
33 μg - 5 500 μg/plate (PIT, E. coli) - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see "details on test system"
- Remarks:
- with and without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Standard plate test and Preincubation test
DURATION
- Preincubation period: 20 minutes (preincubation method only)
- Exposure duration: 48 – 72 hours (both methods)
NUMBER OF REPLICATIONS: three test plates per dose level and control
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
CONTROLS
With S9 mix
• 2-aminoanthracene (2-AA)
- 2.5 μg/plate, dissolved in DMSO for strains: TA 1535, TA 100, TA 1537, TA 98
- 60 μg/plate, dissolved in DMSO for strain: Escherichia coli WP2 uvrA
Without S9 mix
• N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- 5 μg/plate, dissolved in DMSO for strains: TA 1535, TA 100
• 4-nitro-o-phenylenediamine (NOPD)
- 10 μg/plate, dissolved in DMSO for strain: TA 98
• 9-aminoacridine (AAC) (SIGMA, A-1135) 1)
- 100 μg/plate, dissolved in DMSO for strain: TA 1537
• 4-nitroquinoline-N-oxide (4-NQO)
- 5 μg/plate, dissolved in DMSO for strain: E. coli WP2 uvrA - Evaluation criteria:
- The test substance is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test results
- 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
- Remarks:
- cytotoxicty was observed from 33 µg/plate in salmonella strains, and at 5500 µg/plate in E.coli
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found at 5500 μg/plate with and without S9 mix.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A strong bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp- revertants, reduction in the titer) was observed in the standard plate test and in the preincubation assay depending on the strain and test conditions from about 33 μg/plate onward with the Salmonella strains and at 5500 μg/plate using the strain E. coli. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experimental Result:
Experiment 1 (standard plate test)
TA 1535 | TA 100 | TA 1537 | TA 98 | WP2uvrA | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
vehicle control | 11 | 14 | 74 | 82 | 6 | 6 | 17 | 24 | 39 | 47 |
33 | 9 | 12 | 73 | 87 | 3 | 4 | 14 | 18 | 37 | 43 |
100 | 9 | 10 | 65 | 75 | 1 | 1 | 6 | 12 | 31 | 43 |
333 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 36 | 41 |
1000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 34 | 35 |
2750 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 30 | 31 |
5500 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 23 |
pos. control | 802 | 156 | 836 | 718 | 395 | 137 | 587 | 616 | 892 | 257 |
Experiment 2 (standard plate test)
TA 1535 | TA 100 | TA 1537 | TA 98 | |||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
vehicle control | 14 | 15 | 97 | 107 | 6 | 11 | 22 | 27 |
0.33 | 15 | 15 | 96 | 117 | 7 | 10 | 22 | 33 |
1 | 15 | 16 | 93 | 100 | 6 | 11 | 22 | 29 |
3.3 | 13 | 17 | 86 | 115 | 8 | 9 | 24 | 35 |
10 | 12 | 17 | 87 | 99 | 6 | 11 | 23 | 31 |
33 | 15 | 15 | 77 | 107 | 5 | 9 | 21 | 26 |
100 | 8 | 11 | 9 | 47 | 1 | 3 | 6 | 13 |
pos. control | 676 | 151 | 792 | 823 | 461 | 137 | 595 | 592 |
Experiment 3 (preincubation method)
TA 1535 | TA 100 | TA 1537 | TA 98 | WP2uvrA | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
vehicle control | 12 | 13 | 75 | 87 | 6 | 7 | 22 | 30 | ||
0.33 | 13 | 11 | 75 | 86 | 6 | 7 | 20 | 31 | ||
1 | 11 | 13 | 81 | 91 | 6 | 8 | 21 | 30 | ||
3.3 | 12 | 12 | 78 | 90 | 6 | 8 | 22 | 32 | ||
10 | 12 | 11 | 73 | 97 | 6 | 8 | 20 | 28 | ||
33 | 7 | 7 | 35 | 67 | 1 | 3 | 9 | 13 | 44 | 43 |
100 | 46 | 40 | ||||||||
333 | 43 | 45 | ||||||||
1000 | 35 | 40 | ||||||||
2750 | 43 | 46 | ||||||||
5500 | 33 | 41 | ||||||||
pos. control | 791 | 162 | 812 | 700 | 359 | 149 | 539 | 236 | 605 | 253 |
According to the results of the present study, the test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in three experiments carried out independently of each other (standard plate test and preincubation assay). Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions chosen here, it is concluded that the test article is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.
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