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EC number: - | 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:
- 1995-01-13 - 1995-02-24 (experimental phase)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well-documented study according to OECD 471 (previous version) with minor deviations: only four strains of S. typhimurium (TA1535, TA1537, TA98, TA100) were used, data on E.coli WP2 strains or S. typhimurium TA102 are lacking. However, since these strains were mainly included in the recent version of OECD 471 because the four formerly only recommended S. typhimurium strains TA1535, TA1537, TA98 and TA100 may not detect certain oxidising mutagens, cross-linking agents and hydrazines, and this mode of action is not likely to occur based on the chemical structure of the test item, this restriction is considered to be negligible.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- by Umweltministerium Baden-Württemberg
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate
- Molecular formula:
- C27H60NPS2O2 C28H62NPS2O2 C29H64NPS2O2 (main component)
- IUPAC Name:
- Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate
- Test material form:
- liquid
- Details on test material:
- Before Substance ID change known as CAS 71888-91-0 EC 276-159-7
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: NCTC National Collection of Type Cultures, Central Public Health Laboratory in London
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced male Wistar rat S9
- Test concentrations with justification for top dose:
- Maximum concentration: 5000 µg/plate, as stipulated by the guideline
at least 5 analyzable concentration, covering at least 2 logarithmic decades - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: good solubilizing properties
Controls
- Untreated negative controls:
- yes
- Remarks:
- aqua dest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: min. 48 h
SELECTION AGENT (mutation assays): minimal agar
NUMBER OF REPLICATIONS: 3 plates per concentration, two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Rationale for test conditions:
- As set out in OECD TG 471, and as stipulated under REACH
- Evaluation criteria:
- A test item is considered positive if either a significant dose-dependent increase in the number of revertants or a significant and reproducible increase for at least one concentration of the test item is observed.
A significant effect is described as follows:
A test item is considered mutagenic if the number of revertants is increased twice (TA 100) or trice (TA98, TA1535, TA1537) over background.
A dose-dependent increase of the number of revertant is considered also as an indication of a mutagenic potential, even if the above-mentioned increase was not reached.
Commonly valid conditions for the assessment of the results are:
- normal background growth in all agar plates
- normal ranges of spontaneous revertant rates compared with negative control groups without metabolic activation
Ranges of spontaneous revertant rates:
TA98: 15 - 60
TA100: 75 - 200
TA1535: 3 - 37
TA1537: 4 - 31 - Statistics:
- Of each three plates per concentration mean and standard deviation was calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- precipitation occurred at doses >= 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- precipitation occurred at doses >= 500 µg/plate
- Vehicle controls validity:
- not valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- precipitation occurred at doses >= 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- precipitation occurred at doses >= 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none stated
- Effects of osmolality: none stated
- Evaporation from medium: unknown
- Precipitation: at doses >= 500 mg/plate
RANGE-FINDING/SCREENING STUDIES:
In all plates treated with the test item a normal backgroung growth was observed. Due to precipitation at doses >= 500 mg/plate, in the main experiment the following concentrations were tested: 500, 250, 50, 25, and 5 µg/plate
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: no data
- Negative (solvent/vehicle) historical control data: partially exceeded, but without relevance for validity of the experiment
Applicant's summary and conclusion
- Conclusions:
- The study was conducted under GLP according to the previous version of OECD TG 471 and is sufficiently documented, validity criteria were met. Only four strains of S. typhimurium (TA1535, TA1537, TA98, TA100) were used, data on E.coli WP2 strains or S. typhimurium TA102 are lacking. However, since these strains were mainly included in the recent version of OECD 471 because the four formerly only recommended S. typhimurium strains TA1535, TA1537, TA98 and TA100 may not detect certain oxidising mutagens, cross-linking agents and hydrazines, and this mode of action is not likely to occur based on the chemical structure of the test item, this restriction is considered to be negligible. In consequence, the results of this well-conducted study can be considered to be sufficiently reliable to assess the mutagenic potential of the test item. At none of the tested concentrations neither a significant and reproducible increase in revertants nor a dose-dependent increase of revertants at at least one concentration of the test item was observed. Hence, the test item does not need to be considered as mutagenic in bacteria.
- Executive summary:
The study was conducted under GLP according to the previous version of OECD TG 471. S. typhimurium strains TA98, TA100, TA1535, TA1537 were exposed to various concentrations of the test item ranging from 2.5 - 5000 µg/plate in the plate incorporation method ±S9. Two independent experiments were performed.
No cytotoxicity was observed up to the limit dose, precipitation occurred >= 500 µg/plate. Positive and negative control gave the appropriate results. At none of the tested concentrations neither a significant and reproducible increase in revertants nor a dose-dependent increase of revertants at at least one concentration of the test item was observed. Hence, the test item does not need to be considered as mutagenic in bacteria.
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