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EC number: 212-485-8 | CAS number: 822-06-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well documented study report which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
- Reference Type:
- publication
- Title:
- Lack of mutagenic activity of 1,6-hexamethylene diisocyanate
- Author:
- Wagner VO et al.
- Year:
- 2 000
- Bibliographic source:
- Toxicological Sciences 55: 376-382
Materials and methods
- Principles of method if other than guideline:
- METHOD: The test system was exposed to the test substance via the desiccator methodology, a modification of the plate incorporation methodology originally described by Ames et al., Mutat. Res. 31, 347-364 (1975) and updated by Maron and Ames, Mutat. Res. 113, 173-215 (1983). The desiccator methodology has been shown to be an effective method for detecting the genotoxic activity of volatile and gaseous test substances (Wagner et al., Environ. Mol. Mutagen. 19, 68 (1992)). Deviation from the original study protocol: The independent repeat assay was not performed because technical difficulties in dosing the test article using the desiccator methodology make further testing unwarranted. The test article exposure was reduced to approx. 8 hours. After this exposure period, the plates were removed from the desiccator and incubated with the lids replaced such that the total incubation time was approx. 48 to 72 hours. No strains with an AT base pair at the primary reversion site (E. coli WP2 strains or S. typhimurium TA 102) were used to detect cross-linking mutagens.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hexamethylene diisocyanate
- EC Number:
- 212-485-8
- EC Name:
- Hexamethylene diisocyanate
- Cas Number:
- 822-06-0
- Molecular formula:
- C8H12N2O2
- IUPAC Name:
- 1,6-diisocyanatohexane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced male rat liver S9 mix
- Test concentrations with justification for top dose:
- 6, 12, 20, 25, 50 and 150 µL per desiccator
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: 2-aminoanthracene, sodium azide, 9-aminoacridine
- Details on test system and experimental conditions:
- see "Principles of method"
- Evaluation criteria:
- For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test substance. Data sets for strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean untreated control value. Data sets for strains TA98, TAlOO and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the
mean untreated control value.
The following criteria must be met for the mutagenicity assay to be considered valid. All Salmonella tester strain cultures must demonstrate the presence of the deep rough mutation (rfa) and the deletion in the uvrB gene. Cultures of tester strains TA98 and TAI00 must demonstrate the presence of the pK.MI0l plasmid R-factor. All WP2 uvrA cultures must demonstrate the deletion in the uvrA gene. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the untreated controls as follows (inclusive): TA98, 10 - 50; TAI00, 80 - 240; TA1535, 5 - 45; TA1537, 3 - 21; WP2 uvrA, 10 - 60. To ensure that appropriate numbers of bacteria are plated, tester strain culture titers must be greater than or equal to 0.3xl09 cellsjmL. The mean of each positive control must exhibit at least a three-fold increase in the number of revertants over the mean value of the respective untreated control. A minimum of three non-toxic dose levels are required to evaluate assay data. A dose level is considered toxic if one or both of the following criteria are met: (1) A >50 % reduction in the mean number of revertants per plate as compared to the mean untreated control value. This reduction must be accompanied by an abrupt dose-dependent drop in the revertant count. (2) A reduction in the background lawn. - Statistics:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No precipitate was observed but toxicity generally observed at >= 6µL per desiccator, with non-uniform toxicity over at least 25% of the surface of each affected plate. The non-uniform toxicity did not appear to be a function of the location or orientation of the plates in the desiccators. The non-uniform toxicity profile appears to be unique to HDI. In addition, no mutagenic activity was observed in locations on the plates where the background lawns were nontoxic (normal).
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Summary of results from the Salmonella mutagenicity assay with HDI (average revertants per plate ± standard deviation)
Dose (µL per desiccator) | Without metabolic activation |
|||
TA 98 | TA 100 | TA 1535 | TA 1537 | |
Untreated |
15 ± 2 | 185 ± 9 | 17 ± 5 | 5 ± 3 |
6 | 3 ± 1 | 41 ± 9 | 3 ± 2 | 2 ± 2 |
12 | 6 ± 7 | 93 ± 16 | 3 ± 1 | 2 ± 2 |
20 | 5 ± 4 | 15 ± 19 | 2 ± 3 | 2 ± 2 |
25 | 0 ± 1 | 23 ± 8 | 2 ± 2 | 1 ± 1 |
50 | 2 ± 2 | 27 ± 19 | 2 ± 1 | 1 ± 1 |
150 | 1 ± 2 | 34 ± 32 | 3 ± 5 | 2 ± 1 |
Positive control | 343 ± 59 | 667 ± 34 | 599 ± 7 | 401 ± 195 |
Dose (µL per desiccator) | With metabolic activation (liver S9 mix) |
|||
TA 98 | TA 100 | TA 1535 | TA 1537 | |
Untreated | 21 ± 3 | 184 ± 5 | 16 ± 1 | 6 ± 4 |
6 | 14 ± 6 | 92 ± 29 | 5 ± 1 | 2 ± 2 |
12 | 13 ± 8 | 129 ± 19 | 13 ± 1 | 4 ± 2 |
20 | 13 ± 9 | 71 ± 17 | 3 ± 3 | 3 ± 3 |
25 | 13 ± 9 | 95 ± 66 | 9 ± 5 | 1 ± 2 |
50 | 10 ± 7 | 120 ± 9 | 8 ± 2 | 2 ± 1 |
150 | 9 ± 2 | 126 ± 11 | 8 ± 3 | 4 ± 3 |
Positive control | 940 ± 404 | 826 ± 157 | 77 ± 11 | 94 ± 21 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
The results of the Bacterial Reverse Mutation Assay using vapour-phase exposure for 1,6 -hexamethylene diisocyanate indicate that 1,6-hexamethylene diisocyanate does not appear to induce any mutagenic activity with any of the tester strains in the presence and absence of a metabolic activation system.
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