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EC number: 931-209-3 | CAS number: 1337540-53-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-11-19 to 1997-11-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- May 26, 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- December 29, 1992
- Principles of method if other than guideline:
- Study performance followed the old OECD TG 471, implemented in 1983. Therefore neither E. coli WP2 nor S. typhimurium TA102 were tested as required in the current OECD TG 471 from 21st July 1997.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C16-18(even numbered), reaction products with triethanolamine, di-Me sulfate-quaternized
- Cas Number:
- 91032-11-0
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Fatty acids, C16-18(even numbered), reaction products with triethanolamine, di-Me sulfate-quaternized
- Reference substance name:
- Fatty acids, C16-18 even numbered, reaction products with triethanolamine, di-Me sulfate-quaternized
- IUPAC Name:
- Fatty acids, C16-18 even numbered, reaction products with triethanolamine, di-Me sulfate-quaternized
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Additional strain / cell type characteristics:
- other: Histidine auxotroph
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction (purchased as finished prod. from CCR (D-64380 Roßdorf/Darmstadt, Germany; Lot-No. 030797 manufact.: 1997-07-03, Proteine: 24.7 mg/ml S9-fraction). Fraction of male Wistar rat liver induced with Phenobarbital and ß-Naphthoflavone.
- Test concentrations with justification for top dose:
- First test: 8, 40, 200, 1000, 5000 µg/plate
Second test: 5, 10, 50, 100, 200 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solution medium was chosen according to the solubility properties tested preliminary before start of the study.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9-mix Migrated to IUCLID6: 2 µg/plate for TA 1535, TA 100
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9-mix Migrated to IUCLID6: 80 µg/plate for TA 1537
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylenediamine, 40 µg/plate for TA 1538, TA 98
- Remarks:
- without S9-mix
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene, 2.5 µg/plate for TA 1535, TAS 1537, 5.0 µg/plate for TA 100, TA 1538, TA 98
- Remarks:
- with S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 2
NUMBER OF PLATES EVALUATED: three per dose
- Evaluation criteria:
- A combination of the following criteria was considered as a positive result:
- the plate background of non-reverted bacteria did not show any groth reduction versus the respective negative controls.
- The spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range.
- As a rule, the positive controls showed mutation rates exceeding the control values of TA 100 at least by the factor 2.0 and those of the other tester strains at least by the factor 3.0).
- At more than one dose tested, the test substance caused at least a 2.0-fold increase in comparison with the negative controls in the tester strain TA 100. For the other tester strains, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positiv).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- 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
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 1538
- 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
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: not noted
COMPARISON WITH HISTORICAL CONTROL DATA: yes
Applicant's summary and conclusion
- Conclusions:
- There was no evidence of induced mutant colonies over background in any of the tester strains in the presence or absence of mammalian metabolic activation in this study.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471, 1983, strains TA1535, TA 1537, TA 1538, TA 98 and TA 100 of S. typhimurium were exposed to the fully saturated TEA-Esterquat. Two independent experiments were performed at concentrations of 8, 40, 200, 1000 and 5 000 µg/plate and the second experiment at concentrations of 5, 10, 50, 100, 200 µg/plate in the presence and absence of mammalian metabolic activation.
No evidence of biologically significant mutagenic activity of the test item was found in the presence and absence of metabolic activation, up to and including the limit concentration of 5000 µg/plate. Biologically significant bacteriotoxic effects were observed at concentrations of ≥ 200 µg/plate.
The positive controls induced the appropriate responses in the corresponding strains and activity of metabolizing system was confirmed.
There was no evidence of induced mutant colonies over background.
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