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EC number: 227-563-7 | CAS number: 5888-87-9
- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N'-hexane-1,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)
- EC Number:
- 227-563-7
- EC Name:
- N,N'-hexane-1,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)
- Cas Number:
- 5888-87-9
- Molecular formula:
- C20H34N4O4
- IUPAC Name:
- N,N'-hexane-1,6-diylbis(2-oxoazepane-1-carboxamide)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): N,N' -hexane-1 ,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)
- Lot/batch No.: 07112601
- Expiration date of the lot/batch: 26/11/2008
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.31 kg to 2.48 kg.
- Housing: individual box instalIed in conventional air conditioned animal husbanding
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: minimal 5-day acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C to 22°C
- Humidity (%): 40% to 57%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test item was instilIed as supplied
- Concentration (if solution): n.a.
VEHICLE
- Amount(s) applied (volume or weight with unit): n.a.
- Concentration (if solution): n.a.
- Lot/batch no. (if required): n.a.
- Purity: n.a. - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: n.a.
SCORING SYSTEM:
evaluated:
CHEMOSIS (A)
DISCHARGE (B)
REDNESS (C)
IRIS (D)
CORNEA: DEGREE OF OPACITY (E)
CORNEA: EXTENT OF OPACITY (F)
TOOL USED TO ASSESS SCORE: visual
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Examination after 1, 24, 48 and 72 hours after application of the test item
- Score:
- 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible
Any other information on results incl. tables
INDIVIDUAL AND MEAN SCORES OF CONJUNCTIVAE, IRIS AND CORNEA:
Animal n° | Time after treatment | CONJUNCTIVAE | IRIS | CORNEA | |
CHEMOSIS (A) | REDNESS (C) | LESION (D) | OPACITY(E) | ||
A8758 | 24 hours | 0 | 1 | 0 | 0 |
48 hours | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | |
TOTAL | 0 | 1 | 0 | 0 | |
Mean | 0 | 0,3 | 0 | 0 | |
A8760 | 24 hours | 0 | 1 | 0 | 0 |
48 hours | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | |
TOTAL | 0 | 1 | 0 | 0 | |
Mean | 0 | 0,3 | 0 | 0 | |
A8761 | 24 hours | 0 | 1 | 0 | 0 |
48 hours | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | |
TOTAL | 0 | 1 | 0 | 0 | |
Mean | 0 | 0,3 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, the results obtained, under these experimental conditions, enable to conclude that the
test item N,N'-hexane-I,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide) needs not to be
classified according to the criteria for the classification, packaging and labelling of dangerous
substances in compliance with the E.E.C Directives n° 67/548, 2001/59 and 99/45. No symbol and
risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not to
be classified in category 2. No signal word and hazard statement are required. - Executive summary:
The ocular conjunetivae reactions observed during the study have been slight and totally reversible
in the three animals: a slight redness, noted 1 hour and 24 hours after the test item instillation,
associated with a slight chemosis only noted 1 hour after the test item instillation.
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the
test item N,N'-hexane-I,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide) needs not to be
classified according to the criteria for the classification, packaging and labelling of dangerous
substances in compliance with the E.E.C Directives n° 67/548, 2001/59 and 99/45. No symbol and
risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not to
be classified in category 2. No signal word and hazard statement are required.
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