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EC number: 607-997-7 | CAS number: 26776-30-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2002-11-12 to 2002-11-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (1996)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane
- EC Number:
- 607-997-7
- Cas Number:
- 26776-30-7
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane
- Test material form:
- liquid: viscous
- Details on test material:
- 90 % Hexamehylendiisocyanate, oligomeric, caprolactam blocked
10 % Solvesso
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: WISTAR strain Crl: (EI) BR , Charles River Deutschland, Sulzfeld
- young adult animals
- Fasting period before study: maximum 20 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 °C +/- 3° C
- Humidity (%): 30 % - 70 %
- Air changes (per hr): 15 times
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ADMINISTRATION:
- Frequency: single dosage on day 1
- Dose: 2000 mg/kg/bw (1.83 ml/kg), undiluted
- Dose volume was calculated as dose level: density - Doses:
- 2000 mg/kg, correlating to 1800 mg/kg (based on active ingredient of test substance)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: periodic intervals on the dayof dosing (day 1) and once daily thereafter, until day 15
- Body weight: days 1 (pre-administration) 8 and 15
- Necropsy: All survived animals were necropsied at the end of the observation period - Statistics:
- not required
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 800 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: 90 % substance in solvent
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalitiy occurred
- Clinical signs:
- other: Hunched posture, lethargy, rales, red or brown staining of the skin, salivation, chromodacryorrhoea and ptosis were noted among the animals between days 1 and 4. Alopecia was observed in 3 females between days 11 and 15 and in one male between days 5 and
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- no other findings
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Interpretation of results:
- other: as test item a 90 % solution in solvent naphtha was used; the induced effects might be interpreted as solvent driven
- Conclusions:
- The oral LD50 value of 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane in female and male Wistar rats was established to exceed 2000 mg/kg bw for the test substance (> 1800 mg/kg based on active ingredient). No mortalities were observed. Therefore, under the conditions of this study the acute toxicity of 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane after oral exposure in rats is low.
- Executive summary:
The study for assessment of acute oral toxicity with 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane in rats was carried out according to OECD Guideline 423. The test item was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg bw (1800 mg/kg based on active ingredient). Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Hunched posture, lethargy, rales, red or brown staining of the skin, salivation, chromodacryorrhoea and ptosis were noted among the animals between days 1 and 4. Alopecia was observed in 3 females between days 11 and 15 and in one male between days 5 and 15. As test item a 90% solution in solvent naphta was used. The induced effects could be interpreted as solvent driven. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
Therefore the oral LD50 value of 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane in Wistar rats was established to exceed 2000 mg/kg bw (> 1800 mg/kg based on active ingredient).
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