Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 924-903-2 | CAS number: 1190401-47-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
in vitro:
Ames-Test:
Hexane, 1,6-diisocyanato, homopolymer, N-butyl-1-butanamine-blocked was tested in a GLP compliant Ames reverse mutation assay according to OECD guideline 471 using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100 and Escherichia coli WP2 uvr A at 33 to 5000 µg/plate (two independent experiments (standard plate incorporation test and pre-incubation test) and each concentration was tested in triplicate) with and without metabolic activation (BASF SE, 2012). Precipitation of the test substance was found from 2500 μg/plate onward with and without S9 mix. A bacteriotoxic effect was occasionally observed depending on the strain and test conditions from 2500 μg/plate onward. A relevant increase in the number of his+or trp+revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance Hexane, 1,6-diisocyanato, homopolymer, N-butyl-1-butanamine-blocked is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
HPRT-Assay:
A GLP-compliant gene mutation assay, tested according to OECD guideline 476, was performed to investigate the potential of Hexane, 1,6-diisocyanato, homopolymer, N-butyl-1-butanamine-blocked to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster (Harlan 2012).The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation.The concentration range of the main experiments was limited by precipitation of the test item.Precipitation of the test item was observed at 20.0μg/mL and above with metabolic activation (4 hours treatment, experiment I and II) and without metabolic activation (4 h treatment, experiment I). In experiment II without metabolic activation (24 h treatment) precipitation was observed at 40μg/mL and above.Cytotoxic effects were observed in the first experiment at 20.0μg/mL and above without metabolic activation.No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation.Therefore, Hexane, 1,6-diisocyanato, homopolymer, N-butyl-1-butanamine-blocked is considered to be non-mutagenic in this HPRT assay.
In vitro Chromosome Aberration:
In a GLP-compliant chromosome aberration test, tested according to OECD guideline 473, the test item Hexane, 1,6-diisocyanato, homopolymer, N-butyl-1-butanamine-blocked, dissolved in ethanol, was assessed for its potential to induce structural chromosome aberrations in V79cells of the Chinese hamster in vitroin the absence and presence of metabolic activation by S9 mix (Harlan 2012). Two independent experiments were performed. In Experiment I the exposure period was 4 hours with and without S9 mix. In Experiment II the exposure period was 4 hours with S9 mix, 18 and 28 hours without S9 mix. The chromosomes were prepared 18 and 28 hours after start of treatment with the test item. In each experimental group two parallel cultures were set up. At least 100 metaphases per culture were evaluated for structural chromosome aberrations, except for the positive control in Experiment II after 28 hours continuous treatment without metabolic activation, where only 50 metaphases were evaluated. The highest treatment concentration in this study, 2600.0 µg/mL was chosen with regard to the solubility properties of the test item and with respect to the OECD Guideline for in vitromammalian cytogenetic tests. In Experiment I and II, visible precipitation of the test item in the culture medium was observed at 26.6 µg/mL and above in the absence and presence of S9 mix after 4 hours treatment time. In addition, precipitation occurred in Experiment II, in the absence of S9 mix, at 166.4 µg/mL and above after 18 hours continuous treatment. After 28 hours continuous treatment precipitation occurred at 166.4, 416.0 and 2600.0 µg/mL. No relevant influence on osmolarity or pH value was observed. In Experiment I in the absence and presence of S9 mix and in Experiment II in the absence of S9 mix no cytotoxicity was observed up to the highest applied concentration. In Experiment II in the presence of S9 mix cytotoxicity, indicated as reduced cell number, was observed at the highest evaluated concentration (46.6 % of control). In both experiments, in the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying structural chromosome aberrations was observed. The aberration rates of the cells after treatment with the test item (0.0 - 3.5 % aberrant cells, excluding gaps) were slightly above the range of the solvent control values (0.0 - 2.0 % aberrant cells, excluding gaps) and within the range of the laboratory historical solvent control data. Two significant increases were observed in Experiment II after treatment with 10.6 and 26.6 µg/mL. Although these increases of 3.0 and 3.5 % aberrant cells, excluding gaps were statistically significant compared to the low response (0.0 % aberrant cells, excluding gaps) in the solvent control data, the response is within the laboratory historical solvent control data range (0.0 - 4.0 % aberrant cells, excluding gaps). Therefore, the statistical significance has to be regarded as being biologically irrelevant. No evidence of an increase in polyploid metaphases was noticed after treatment with the test item as compared to the control cultures. In both experiments, either EMS (1000.0 or 600.0 µg/mL) or CPA (1.4 or 2.0 µg/mL) were used as positive controls and showed distinct increases in cells with structural chromosome aberrations. In conclusion, it can be stated that under the experimental conditions reported, the test item Hexane, 1,6-diisocyanato, homopolymer, N-butyl-1-butanamine-blocked did not induce structural chromosomal aberrations in V79cells of the Chinese hamster in vitro, when tested up to precipitating and/or cytotoxic concentrations.
Short description of key information:
Ames-test (BASF, 2012): negative
HPRT-Assay (Harlan, 2012): negative
Chr. Abr. (Harland, 2012): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available data, the test substance is not classified with regard to genetic toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.
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.