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EC number: 810-418-2 | CAS number: 1703784-30-8
- 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:
- 10-12-2018 to 06-03-2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
- EC Number:
- 810-418-2
- Cas Number:
- 1703784-30-8
- IUPAC Name:
- Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
- Test material form:
- liquid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat; Arochlor 1254 induced)
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 3160 and 5000 μg/ plate
- Vehicle / solvent:
- highly purified water
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation: TA 1535; TA 100; 10 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation: TA 1537; 100 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation: TA 98, 10 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation: E.coli WP2 uvra pKM101, 5 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation: TA100, TA1535, E.coli WP2 uvra pKM101, 2 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation: TA 98, TA 1537, 10 µg/plate
- Details on test system and experimental conditions:
- The first experiment was carried out as the standard plate incorporation method whereas the second was carried out as the preincubation method.
- Evaluation criteria:
- A test substance producing no biologically relevant positive response in any one of the bacterial strains tested is considered to be non-mutagenic in this system.
A biologically relevant response is described as follows:
If the number of revertants is at least twice the spontaneous reversion rate for TA 98, TA 100, TA 1535, TA 1537 and E.coli WP2 and/or if there is a concentration related increasing number of revertants over the range tested. - Statistics:
- yes, p <= 0.05, U-test according to MANN and WHITNEY
Results and discussion
Test resultsopen allclose all
- 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: highly purified water was used as vehicle
- Precipitation: test item precipitation was noted at concentrations of 5000 µg / plate with E.coli WP2 uvra pK101 in both experiments.
COMPARISON WITH HISTORICAL CONTROL DATA: The results of the negative and positive control cultures were within the range of the historical data generated by LPT.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
The reported data show that the test item n did not induce gene mutations in the S. typhimurium and E.coli WP2 tester strains with and without mammalian metabolic activation. In conclusion the results of this bacterial reverse mutation assay were considered negative. - Executive summary:
Preliminary test
PU-2018-821 was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in the Salmonella typhimurium test strain TA100. Ten concentrations ranging from 0.316 to 5000 μg PU-2018-821/plate were tested. No signs of cytotoxicity were observed, neither in the experiment without nor in the experiment with metabolic activation. Hence, 5000 μg PU-2018-821/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
Main study
Six concentrations ranging from 31.6 to 5000 μg PU-2018-821/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
Cytotoxicity
Cytotoxicity in form of reduction of the number of revertants by more than 50% was noted in the E. coli strain WP2 uvrA [pKM101] in all experiments: in the experiments without metabolic activation at the concentrations of 3160 and 5000 μg/plate, in the experiments with metabolic activation at the concentration of 5000 μg/plate
Mutagenicity
No increase in revertant colony numbers as compared with control counts was observed for PU-2018-821, tested up to the top concentration of 5000 μg/plate that led to cytotoxicity in E. coli strain WP2 uvrA [pKM101] in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test).
The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system. The results of the negative and positive control cultures were within the range of the historical data . Hence, all acceptance criteria are met.
In conclusion, under the present test conditions, PU-2018-821 tested up to a concentration of 5000 μg/plate that led to cytotoxicity in the Escherichia coli strain WP2, caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and in the Escherichia coli strain WP2 uvrA [pKM101], neither in the plate incorporation test nor in the preincubation test, each carried out without and with metabolic activation.
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