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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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximisation test was a generally accepted method at the time of the test conduction (2008).
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F-69592 L' Arbresle)
- Age at study initiation: 4 weeks
- Weight at study initiation: 235 to 272 g
- Housing: The animals were housed either in groups of 2 or 3 in polycarbonate containers
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: minimum acclimatisation period of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19°C and 22°C
- Humidity (%): between 35% and 58%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- test item diluted at 50% and at 25% in liquid paraffin
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- test item diluted at 50% and at 25% in liquid paraffin
- No. of animals per dose:
- negative control: 5
treated group: 10 - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In view of these results, under these experimental conditions, the test item N,N'-hexane-1,6-
diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide) needs not to be classified, in accordance with
the criteria for classification, packaging and labelling of dangerous substances and preparations of the
E.E.C. Directives 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 1. No signal word and hazard statement are required. - Executive summary:
The aim of the study was to evaluate the possible allergenic activity ofthe test item N,N'-hexane-l,6 -
diylhis(hexahydro-2 -oxo-1H-azepine-l-carboxamide) after intradermic injection and topical
administration in guinea pigs.
After induction (intradermic injection at 10% and topical application at 50%) of 10 Guinea Pigs of
treated group with the test item N,N'-hexane-l,6 -diylbis(hexahydro-2 -oxo-1H-azepine-1 -carboxamide)
and a 10 -day rest phase, the challenge phase, under occlusive dressing for 24 hours,
consisted to a single topical application of the test item diluted at 50% and at 25% in liquid paraffin.
The experimental protocol was established according the OECD guideline No. 406 dated July 17th,
1992 and the method B.6 of the EEC No. 96/54 dated July 30th,1996.
It was recorded a slight to moderate erythema, in respectively 20% (2/10) and 10% (1 /10) of the
animals from the treated group, 24 and 48 hours after the challenge phase, on the treated areas at 50%
and 25%. These reactions were totally reversible at the reading time 72 hours.
No cutaneous intolerance reaction was recorded in animals from the negative control group.
In conclusion, in view of these results, under these experimental conditions, the test item N,N'hexane-
l,6 -diylbis(hexahydro-2 -oxo-1H-azepine-1 -carboxamide) needs not to be classified, in
accordance wilh the criteria for classification, packaging and labelling of dangerous substances and
preparations of the E.E.C Directives 67/548, 2001159 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 I. No signal word and hazard statement are required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In conclusion, in view of these results, under these experimental conditions, the test item N,N'hexane-
l,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide) needs not to be classified, in
accordance wilh the criteria for classification, packaging and labelling of dangerous substances and
preparations of the E.E.C Directives 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 1. No signal word and hazard statement are required.
Migrated from Short description of key information:
In conclusion, in view of these results, under these experimental conditions, the test item N,N'hexane-
l,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide) needs not to be classified, in
accordance wilh the criteria for classification, packaging and labelling of dangerous substances and
preparations of the E.E.C Directives 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 1. No signal word and hazard statement are required.
Justification for selection of skin sensitisation endpoint:
The only available endpoint with respect to sensitisation
Justification for classification or non-classification
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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