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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Information that are available from 28 d study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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:
- other: OECD 407
- Deviations:
- yes
- Remarks:
- As none of the deviations were rated as critical, deviation notes were not issued. The study report reflects the deviations in an appropriate way.
- GLP compliance:
- yes (incl. QA statement)
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-1 H-azepine-1-carboxamide)
- Substance type: organic substance
- Physical state: solid
- Analytical purity: 100%
- Lot/batch No.: 07112601
- Storage condition of test material: Room temperature (20°C ± 5°C), dry
- Other:
The test item arrived at NewLab BioQuality GmbH on 07 January 2008 at ambient
temperature and was stored at room temperature on a cJosed shelf upon arrival. Additional
test item of the same batch arrived at NewLab BioQuality GmbH on 11 March 2008 at
ambient temperature and was stored at room temperature on a closed shelf upon arrival.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkel mann GmbH, Gartenstraße 27, 33178 Borehen, Germany
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: males: 167 to 175 grams (mean), females: 151 to 159 grams (mean)
- Fasting period before study: no
- Housing: Clean conventional housing: aeration with approx. 10 air changes per hour, room climate 22 ± 3°C at 30-70% relative humidity, artificial lighting , 12 h Iight / 12 h dark
Eight groups of five animals each in open makroion cages type 2000P (TechniPlast)
Lignocel hygienic animal bedding (J. Rettenmaier & Söhne GmbH + Co. KG, 73494 Rosenberg)
- Diet (e.g. ad libitum): Maintenance diet rat/mouse, pellets, No. 1324 (Altromin GmbH & Co. KG, 32791 Lage), ad /ib.
- Water (e.g. ad libitum): Autoclaved community tap water, ad lib.
- Acclimation period: 8 days (male) / 9 days (female)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70% relative humidity
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): daily
- Mixing appropriate amounts with (Type of food): corn oil
VEHICLE
- Justification for use and choice of vehicle (if other than water): test item has low solubility in water
- Amount of vehicle (if gavage): The test solutions were intended for an application volume of 8 ml per kg body weight. - Duration and frequency of treatment / exposure:
- 28 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 / 63 /250 / 1000 mg/kw bw
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- no
- Details on study design:
- - Dose selection rationale:
Prior to this study, an acute oral toxicity study according to OECD 401 was performed in rats, which resulted in an LD50 of more than 2000 mg/kg body weight.
In a previously performed dose range finding study with dose escalation, the test item was administered in doses up to 2000 mg/kg body weight over a time period of 19 days and produced no observable toxic effects in the test animals. For this study, a high dose of 1000 mg/kg body weight was determined on request of the sponsor.
- Rationale for animal assignment (if not random):
On the day of arrival, the animals were caged in groups of five according to the following
stratification protocol: rats were weighed individually and grouped into weight categories, the
main group consisting of animals weighing between 100 g and 120 g. These were placed
consecutively into prepared cages. Rats weighing more than 120 g, but not more than 140 g,
were caged similarly after the main weight group was placed. At the time point of
stratification, no rat weighed less than 100 g or more than 120 g.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- no data available
- Details on distribution in tissues:
- Biochemical parameters (cholesterol and albumin/globulin ratio) suggest the liver to be the main target organ for the substance.
- Details on excretion:
- no data available
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- no data available
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- no data available
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
The repeated daily oral administration of N,N'-hexane-1 ,5-diylbis(hexahydro-2-oxo-1 H-azepine-
1-carboxamide) to Wistar-Unilever rats at dose levels of 1000, 250, and 63 mg/kg
bodyweight for a treatment period of 28 days produced mild treatment-related alterations in
the liver of the high dose groups. - Executive summary:
Analysis of hematology and serum biochemistry showed normal results in most instances.
The blood parameters of male animals treated with the test item showed erratic and few significant alterations when compared to the vehicle control group. Chloride and the blood clotting time were slightly raised in the high dose group. In the medium dose group, MCHC was slightly raised and reticulocytes and Albumin was slightly lowered in comparison to their control group. The low dose group showed slightly elevated numbers of segmented neutrophiles and a slightly decreased number of Iymphocytes. All parameters measured in the blood of the male animals were without pathological findings. The most prominent effects of the females of the high dose group and the medium dose group were a significantly raised level of cholesterol and of globulin, indicating liver stress.
The raised levels of total protein and of the albumin/globulin ratio of the high dose group and, milder, in the medium dose group when compared to the vehicle control group also point to the liver as main target of the test item. A slight increase of monocytes and leucocytes was restricted to the female high dose group and possibly indicates a mild effect of liver stress.
Although some significant changes were observed, none of the observed average data points were overall extremely out of range for rats of this strain and age. Other biochemical parameters and the blood cell counts showed no significant differences among the groups.
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