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EC number: 500-209-1 | CAS number: 68412-54-4 1 - 2.5 moles ethoxylated
- 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:
- 22 March, 2010 to 14 May, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD Guideline 471, EC 440/2008 B.13/14 and EPA OPPTS 870.5100 and with GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Nonylphenol, branched, ethoxylated
- EC Number:
- 500-209-1
- EC Name:
- Nonylphenol, branched, ethoxylated
- Cas Number:
- 68412-54-4
- Molecular formula:
- not available for this UVCB
- IUPAC Name:
- Nonylphenol, branched, ethoxylated (> 1 < 2.5 mol EO)
Constituent 1
Method
- Target gene:
- Salmonella typhimurium
Species / strainopen allclose all
- Species / strain / cell type:
- other: TA 100, TA 1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Species / strain / cell type:
- other: TA 98, TA 1537
- Details on mammalian cell type (if applicable):
- Not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Species / strain / cell type:
- other: TA 98, TA 100, TA 102, TA 1535, TA 1537
- Details on mammalian cell type (if applicable):
- Not applicable
- Metabolic activation:
- without
- Metabolic activation system:
- Not applicable
- Test concentrations with justification for top dose:
- Experiment 1:
- 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 2500 μg/plate
TA 98, TA 100, TA 1535, TA 102 with and without metabolic activation; TA 1537 with metabolic activation
- 0.3.6, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000 and 2500 μg/plate
TA 1537 without metabolic activation.
Experiment 2:
- 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 2500 μg/plate
TA 98, TA 100, TA 102 with and without metabolic activation; TA 1535 and TA 1537 with metabolic activation.
- 0.1, 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316 and 1000 μg/plate
TA 1535 without metabolic activation
- 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316 and 1000 μg/plate
TA 1537 without metabolic activation - Vehicle / solvent:
- TA 100, TA 1535: distilled water
TA 98, TA 1537: DMSO
TA 102: distilled water
TA 98, TA 100, TA 102, TA 1535, TA 1537: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 and TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine (4-NOPD)
- Remarks:
- TA 98 and TA1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- TA98, TA 100, TA 1535, TA 1537 and TA 102 (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 1 h (experiment 2)
- Exposure duration: 48 h
- Expression time (cells in growth medium): 48 h
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
SELECTION AGENT (mutation assays): Not applicable
SPINDLE INHIBITOR (cytogenetic assays): Not applicable
STAIN (for cytogenetic assays): Not applicable
NUMBER OF REPLICATIONS: Triplicate
NUMBER OF CELLS EVALUATED: Not applicable
DETERMINATION OF CYTOTOXICITY
- Method: By detecting clear or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control. - Evaluation criteria:
- NPEO is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one test strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if a tester strains TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 98, TA 1535 and TA 1537 the number of reversions is at least three times higher
as compared to the reversion rate of the solvent control. - Statistics:
- According to the OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results in not regarded as neccesary.
A test substance producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Results and discussion
Test results
- Species / strain:
- other: TA 98, TA 100, TA 102, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Precipitation of the test item was observed in all tester strains used in experiment 1 and 2 with and without metabolic activation.
Toxic effects of the test item was observed in all tester strains used in experiment 1 and 2 (with and without metabolic activation).
The reduction of in the number of revertants down to a mutation factor of 0.5 found in experiment 2 in tester strain TA 1535 at a dose of 0.1 μg/plate (without metabolic activation) was regarded as not biologically relevant due to lack of a dose-response relationship.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test substance at any concentration level, neither in the presence nor absence of metabolic activation in experiment 1 and 2.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, it can be stated that the substance does not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. The test substance is therefore not considered as mutagenic in this bacterial mutation assay. - Executive summary:
An Ames test was conducted with the following tester strains: Salmonella typhimurium: TA 98, TA 100, TA 102, TA 1535 and TA 1537. In two independent experiments, several concentrations of NPEO were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls (negative and/or solvent as well as positive control), were tested in triplicateup to 2,500 µg/plate. Precipitation of the test substance was observed in all tester strains used in experiments 1 and 2 (with and without metabolic activation). Toxic effects were noted in all tester strains used in the experiments. No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test substance at any concentration level, neither in the presence nor absence of metabolic activation in experiments 1 and 2. The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments. Under the experimental conditions, NPEO did not cause gene mutations by base pair changes or frame shifts in the genome of the tester strains used. NPEO was considered not mutagenic in this bacterial mutation assay (Wallner B, 2010).
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