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EC number: 276-957-5 | CAS number: 72869-86-4
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study planned
- Study period:
- The test will be conducted after a final decision on the requirement to carry out the proposed test has been taken and a deadline to submit the information required has been set by the Agency.
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate and 7,9,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate (CAS No. 72869-86-4)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No adequate and reliable GLP studies addressing genetic toxicity in vivo are available with the test substance itself or similar substances defined according to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006.
- Available non-GLP studies: No adequate and reliable non-GLP studies addressing genetic toxicity in vivo are available with the test substance itself or similar substances defined according to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006.
- Historical human data: not available
- (Q)SAR methods: not applicable to assess the full scope of an in vivo genetic toxicity study
- In vitro methods:
A reliable GLP-compliant in vitro genetic toxicity study is available (reference 7.6.1-1). In addition two reliable publications regarding in vitro genetic toxicity study are available (reference 7.6.1-2 and 7.6.1-3).
An Ames test was conducted in 2009 with reaction mass of 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate and 7,9,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate according to OECD Guideline 471 which was judged to be negative (reference 7.6.1-1). Briefly, in two independent experiments, the Salmonella typhimurium strains TA 97a, TA 98, TA 100, TA 102 and TA 1535 were exposed to the test substance dissolved in DMSO using either the preincubation or the plate incorporation method. Test substance concentrations of 50, 150, 500, 1501 and 5004 µg/plate were selected for the plate incorporation test with and without metabolic activation. In the second experiment, 312, 624, 1247, 2493 and 4986 µg/plate were selected for the preincubation method with and without metabolic activation. No signs of cytotoxicity were observed up to and including the limit concentration. Up to 5000 µg/plate, the test substance did not induce an increase in the mutation frequency of the tester strains in the presence and absence of a metabolic activation system. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. Under the conditions of this experiment, the test substance did not show mutagenicity in the selected S. typhimurium strains in the presence and absence of metabolic activation.
An in vitro micronucleus assay was conducted in 2001 with the test material which was judged to be ambiguous (reference 7.6.1-2). The induction of micronuclei by the test material dissolved in DMSO was investigated in Chinese Hamster lung fibroblasts (V79). Cytotoxicity was evaluated in a preliminary study to define concentration ranges for the main study. In two independent experiments, the cells were exposed to the test material at concentrations of 11.75, 23.5, 35.25 µg/mL for 24 h in the absence of metabolic activation. At cytotoxic concentration levels of the test substance (≥ 24 µg/mL) the numbers of micronuclei were slightly increased in the absence of metabolic activation. Ethyl methanesulphonate was used as positive control and produced a distinct increase in micronuclei frequency indicating that the test conditions were adequate. Thus, under the conditions of this experiment, the potential of the test substance to induce micronuclei is equivocal.
An in vitro gene mutation assay (HPRT test) was conducted in 1998 with the test material which was judged to be negative (reference 7.6.1-3). The mutagenic potential of the test material dissolved in DMSO was investigated in Chinese Hamster lung fibroblasts (V79). Initial cytotoxicity of the test substance on day 1 after exposure was indicated by cell numbers plating efficiency. The cells were exposed to the test material at concentrations of 11.75, 23.5, 35.25 µg/mL for 24 h in the absence of metabolic activation in three replicate cultures. A dose-dependent decrease of cell numbers caused by increasing concentrations was observed. No mutagenic activity of the test material was detected. Ethyl methanesulphonate was used as positive control and produced a distinct increase in mutant frequency indicating that the test conditions were adequate. Thus, under the conditions of this experiment, the test substance did not show mutagenicity in V79 cells without metabolic activation.
Due to the positive result in the in vitro micronucleus test without metabolic activation at cytotoxic concentration a micronucleus test in vivo should be conducted to conclude on genotoxic potential of the test substance.
- Weight of evidence: no weight of evidence data available
- Grouping and read-across: no read-across data available
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate
- EC Number:
- 276-957-5
- EC Name:
- 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate
- Cas Number:
- 72869-86-4
- Molecular formula:
- C23H38N2O8
- IUPAC Name:
- 2-[({2,2,4-trimethyl-6-[({2-[(2-methylprop-2-enoyl)oxy]ethoxy}carbonyl)amino]hexyl}carbamoyl)oxy]ethyl 2-methylprop-2-enoate; 2-[({2,4,4-trimethyl-6-[({2-[(2-methylprop-2-enoyl)oxy]ethoxy}carbonyl)amino]hexyl}carbamoyl)oxy]ethyl 2-methylprop-2-enoate
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.