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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Oligomerisation products of hexamethylene diisocyanate, isocyanurate type, reacted with 2-hydroxyethyl acrylate.
- IUPAC Name:
- Oligomerisation products of hexamethylene diisocyanate, isocyanurate type, reacted with 2-hydroxyethyl acrylate.
- Test material form:
- liquid
- Details on test material:
- CAS: 078567-28-9
Constituent 1
- Specific details on test material used for the study:
- CAS No.: 78567-28-9; Batch No.: WDJ 1853 D-3; Appearance: clear colorless viscous liquid
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Following doses of the test substance were evaluated: 5000; 1600; 500; 160; 50; 16 ug/plate.
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- mitomycin C
- other: nitrofurantoin, 4-nitro-1,2-phenyiene diamine, cumene hydroperoxide and 2-aminoanthracene
- Details on test system and experimental conditions:
- The initial plate incorporation method:
For the mutant count, one plate was used, both with and without S9 mix for each strain and dose. One plate filled with the solvent minus the test substance, comprised the negative control. Each positive control also contained one plate per station. In experiments without S9 mix buffer was used as replacement.
The amount of solvent for the test substance and for the controls was 0.1 ml/plate.
The doses for the first trial were routinely determined on the basis of the standard protocol: if not limited by solubility 5000 ug or 5 uL per plate were used as the highest dose. At least five additional doses were routinely used. If less than three doses were used for assessment, at least two repeats were performed. The results of the first experiment were then considered as a pre-test for toxicity. However, in case of a positive response or if at least three doses could be used for assessment, the first trial was included in the assessment. If the second test confirmed the results of the first, no additional repeat was performed.
The independent repeat was performed as reintubation in a water bath at 37 °C for 20 min. At the end of the reintubation period 2 ml of molten soft agar were added to the tubes, the content mixed and plated.
For the mutant count, one plate was used for each strain and dose. One plate filled with the solvent minus the test substance, comprised the negative control. Each positive control also contained one plate per station. In experiments without S9 mix buffer was used as replacement.
The doses of this trail were determined on the basis of the results of the plate incorporation assay.
The toxicity of the substance was assessed in three ways:
- Gross appraisal of background growth on the plates for mutant determination.
- Marked and dose dependent reduction in the mutant count per plate compared to the negative controls.
- Titer was determined. The dilution of bacterial suspensions used for the determination of titers was 1:1000000. Titers were determined under the same conditions as were mutations, except that the histidine concentration in the soft agar was increased five-fold to permit the complete growth of bacteria.
The tests were performed with and without S9 mix. The counts were made after plates were incubated for 48 h at 37 °C. - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537, at least a threefold increase should be reached. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgement.
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
- Remarks:
- >160 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >160 ug/plate
- 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:
- cytotoxicity
- Remarks:
- >160 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >160 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >160 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The Ames test screening employing doses up to 5000 ug per plate showed the test substance to produce bacteriotoxic effects starting at 160 ug/plate.
None of the five strains concerned showed in the plate incorporation test a dose-related and biologically relevant increase in mutant counts over those of negative controls (with and without S9 mix).
The positive controls increased mutant counts to well over those of the negative controls, and thus demonstrated the system’s sensitivity and the activity of the S9 mix.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was not considered to be mutagenic in Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in the absence and presence of metabolic activation.
- Executive summary:
A study was conducted to determine the mutagenic potential of the test substance according to OECD Guideline 471 and EU Method B.13/14. The test substance was evaluated using five strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537). Following concentrations of the test substance were evaluated: 0, 16, 50, 160, 500, 1600 and 5000 μg/plate. Following incubation in the plate incorporation assay, the test substance produced cytotoxic effects starting at 160 ug/plate. None of the five strains tested showed a dose-related and biologically relevant increase in mutant colony counts over those of negative controls (with and without S9 mix). Under the study conditions, the test substance was not considered to be mutagenic in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in the absence and presence of metabolic activation (Herbold, 2002).
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