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EC number: 806-734-5 | CAS number: 109828-01-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study under GLP consitions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 66790-57-6
- Cas Number:
- 66790-57-6
- IUPAC Name:
- 66790-57-6
- Test material form:
- other: amber viscous liquid
- Details on test material:
- Content: 100 & Additin E459
Main Compound: Triethyleneglycol dimaleate (86 %)
Byproduct: triethyleneglycol monomaleate (9 %)
Constituent 1
Method
- Target gene:
- gene mutation by base-pair changes or frame-shifts in the genome
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S9 fraction was prepared form the livers of Aroclor 12254-induced male Sprague-Dawley rats.The S9-mix was freshly prepared, kept on ice and used only on the same day.
- Test concentrations with justification for top dose:
- 0 (solvent control), 50, 160, 500, 1600 5000 µg/plate
- Vehicle / solvent:
- demineralized water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- other: 4-Nitro-o-phenylene diamine, Mitomycin C, Cumene hydroperoxide, Anthracene-2-amine
- Details on test system and experimental conditions:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102. pre-incubation methodology and plate incorporation methodology, 2 independent trials with S9-mix with each methodoloy snd 2 independent trials without S9-mix with each methodoloy
- Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be positive result.
For TA 1535, TA100, TA1537 and TA98 this increase should be about twice of the solvent controls. For TA102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative.
However, these criteria may be overruled by good scientific judgement.
In questionable results, investgations should continue, possibly with modifications, until a final evaluation is possible. - Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- None of the 5 strains used showed a dose-related and biologically relevant increase in mutant counts over those of the solvent controls in the plate incorporation test. This applied both to the tests with and without S9-mix and was confirmed by the results of the pe-incubation trials.No bacteriotoxic effects or precipitations of the substance were observed.
The positive controls increased mutant counts to well over the solvent controls, and thus demonstrated the sysem's sensitivity and the activity of the S9-mix - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
Additin E459 was investigated for point mutagenic effects according to OECD TG 471 and GLP using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and in the absence of a metabolic activation systen. The test was performed using the the plate incorporation and the pre-incubation methodology with doses up to and including 5000 µg/plate.
None of the 5 strains used showed a dose-related and biologically relevant increase in mutant counts over those of the solvent controls in the plate incorporation test. This applied both to the tests with and without S9-mix and was confirmed by the results of the pe-incubation trials.No bacteriotoxic effects or precipitations of the substance were observed. The positive controls increased mutant counts to well over the solvent controls, and thus demonstrated the sysem's sensitivity and the activity of the S9-mix.
Therefore, Additin E 459 was considered to be non-mutagenic in the Ames test under the conditions reported.
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