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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
Substance is not irritating to skin.
Substance is not irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA, Hautgiftigkeit nach Draize (1959)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 8
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: after 24h and after 72h; mean value is determined
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable, no irritation occured
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: FDA
- Conclusions:
- The test item has not to be classified as "irritant".
- Executive summary:
The test item has not to be classified as "irritant".
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- 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 - 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 - 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
Only study available
Justification for selection of eye irritation endpoint:
Study is assessed with the highest reliability amongst the studies
on the subject "eye irritation"
Justification for classification or non-classification
The substance has neither to be classified into the hazard class "skin corrosion / irritation" nor the hazard class "serious eye damage / eye irritation".
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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