Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 261-879-6 | CAS number: 59719-67-4
- 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: gene mutation
- Type of information:
- experimental study planned
- Study period:
- The study will be performed in 2021 or in the following years depending on the ECHA decision.
- 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: Incozol 4 (bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate, CAS 59719-67-4, EC 261-879-6)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX IX OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: There are no GLP studies available for this substance covering the endpoint genetic toxicity in vivo (gene mutation).
- Available non-GLP studies: There are no non-GLP studies available for this substance covering the endpoint genetic toxicity in vivo (gene mutation).
- (Q)SAR: QSAR approaches for in vivo genotoxicity can be used as additional information in weight of evidence- or read across approaches or to assist in developing testing strategies. (ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance, 2017). QSAR predictions can not be used to cover the in vivo genotoxicity endpoint alone but only as supporting information.
- Weight of evidence: There is no weight of evidence information available to cover the endpoint genetic toxicity in vivo (gene mutation).
- Grouping and read-across: There are no substances which apply for read-across addressing genetic toxicity in vivo (gene mutation).
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO IX (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The substance is fully registered according to REACH Annex IX. Experimental in vitro genetic toxicity studies are available according to the standard information requirements of REACH Annex VII and VIII. One of these studies (in vitro gene mutation study in bacteria conducted by the General Testing Research Institute of Japan Oilstuff Inspectors' Corporation, Study no. B090953, Report no. AK09-21-0128, year: 2009) led to a positive result. In this Ames test, the number of revertant colonies induced by the test substance was more than twice of that of the corresponding negative (solvent) control for Salmonella typhimurium TA100 and Escherichia coli WP2uvrA- without metabolic activation, and for Salmonella typhimurium TA100 with metabolic activation. The result was reproducible. Therefore, the substance was considered mutagenic in this study.
There are no results available from an in vivo genetic toxicity study already. In line with Annex IX, column 2 of the REACH regulation, the registrant therefore proposes an in vivo somatic cell genotoxicity study.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
The Registrant is willing to conduct an in vivo mutagenicity study, i. e. in vivo mammalian alkaline comet assay according to OECD TG 489 in the rat via oral gavage administration. The current testing proposal will be submitted both under EU REACH and UK REACH to adress the data gap in the study requirements.
The study will be commissioned as soon as a final desicion is available.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Test material
- Reference substance name:
- Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate
- EC Number:
- 261-879-6
- EC Name:
- Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate
- Cas Number:
- 59719-67-4
- Molecular formula:
- C24H46N4O6
- IUPAC Name:
- bis[2-(2-isopropyl-1,3-oxazolidin-3-yl)ethyl] hexane-1,6-diylbiscarbamate
Constituent 1
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.
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