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EC number: 950-746-4 | 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:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- S. typhimurium TA 1538
- Principles of method if other than guideline:
- Use of S. typhimurium strain TA 1538 instead of strain TA 102.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine
- Cas Number:
- 68425-57-0
- Molecular formula:
- not applicable
- IUPAC Name:
- Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine
- Test material form:
- solid: crystalline
- Details on test material:
- Name: Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine
CAS No.: 68425-57-0
Physical state: white solid at 20 °C (turbid, non-pourable paste)
Constituent 1
- Specific details on test material used for the study:
- Name: Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine (Phosphorsaeure (C8-C10-Alkyl)-ester, DEA-Salz)
CAS No.: 68425-57-0 (68186-45-8)
Physical state: white solid at 20 °C (turbid, non-pourable paste)
Method
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- → his+ reversions. The S. typhimurium strains are constructed to differentiate between base pair (TA 100, TA 1535) and frameshift (TA 98, TA 1537, TA 1538) mutations.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Remarks:
- S. typhimurium TA 98 his D3052 rfa- uvrB- R+
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Remarks:
- S. typhimurium TA 100 his G46 rfa- uvrB- R+
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535
- Remarks:
- G46 rfa- uvrB-
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1537
- Remarks:
- his C3076 rfa- uvrB-
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Remarks:
- his D3052 rfa- uvrB-
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- The test substance was tested in two independent test series (plate incorporation assay) at concentration ranges of 8.0 - 5000 µg/plate (first test) and 6.25 - 1600 µg/plate (second test and repetition). Toxic effects were noted at concentrations of 200 µg/plate or higher.
- Vehicle / solvent:
- Aqua dest.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-aminoanthracene: TA 98 (-S9/+S9), TA 1535 (-S9/+S9), TA 100 (-S9/+S9); TA 1537 (-S9), TA 1538 (-S9/+S9); 4-Nitro-o-phenylendiamine: TA 98 (-S9/+S9), TA 1538 (-S9/+S9);
- Details on test system and experimental conditions:
- In order to investigate the potential of the test item for its ability to induce gene mutations the plate incorporation test (experiment I & II) was performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538. In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate.
Solutions of the test substance were prepared in aqua dest. and diluted in aqua dest. just before use. The following concentrations were tested:
1st test: 8, 40, 200, 1000 and 5000 pg/plate
2nd test: 6.25, 25, 100, 400 and 1600 pg/plate (and repetition) - 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 growth 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 positive. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- Aqua dest.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Sodium azide & 2-Aminoanthracene (-S9/+S9)
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- Aqua dest.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Sodium azide & 2-Aminoanthracene (-S9/+S9)
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- Aqua dest.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 9-Aminoacridine & 2-Aminoanthracene (-S9/+S9)
- Key result
- 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
- Remarks:
- 4-Nitro-o-phenylendiamine & 2-Aminoanthracene (-S9/+S9)
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- Aqua dest.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 4-Nitro-o-phenylendiamine & 2-Aminoanthracene (-S9/+S9)
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce point mutations by base-pair changes or frameshifts in the genome of the strains used.
Therefore, the test item is not considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
In order to investigate the potential of the test item for its ability to induce gene mutations two plate incorporation tests (experiment I & II) were performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538. No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II. All criteria of validity were met.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce point mutations by base-pair changes or frameshifts in the genome of the strains used. Therefore, the test item is not considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
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