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EC number: 308-208-6 | CAS number: 97925-95-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-07-06 - 1990-11-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions. Analytical purity of test material not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- Deviations:
- yes
- Remarks:
- analytical purity of test material not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.
- EC Number:
- 308-208-6
- EC Name:
- Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.
- Cas Number:
- 97925-95-6
- Molecular formula:
- Not applicable - multiconstituent substance
- IUPAC Name:
- Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan, on July 18, 1989.
- Age at study initiation: 5-6 months
- Weight at study initiation: 8.7-10.2 kg for males, 6.6-9.3 kg for females
- Housing: Individually in elevated, stainless-steel cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.7-25.6
- Humidity (%): 13-100%
- Air changes (per hr): 10/h
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- other: Capsule
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100%
- Amount of vehicle (if gavage): 1 capsule/day
- Purity: 100% - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Routine concentration analyses indicated that animals were generally dosed with formulations that were within ± 10% of the target range. In cases where the percent target was not within this range, formulations were remixed and reanalyzed during the study week.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
15, 30 and 100 mg/kg bw/day
Basis:
other: Nominal in capsule
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once each day
DETAILED CLINICAL OBSERVATIONS: Yes,
- Time schedule: Twice each day
BODY WEIGHT: Yes
- Time schedule for examinations: Prior to treatment and weekly thereafter
FOOD CONSUMPTION
- Time schedule for examinations: Weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: On all dogs prior to treatment and on the control and high-dose dogs prior to termination of treatment
HAEMATOLOGY: Yes, cell morphology hemoglobin, corrected leukocyte count, leukocyte count, erythrocyte count, leukocyte differential, hematocrit, platelet count
- Time schedule for collection of blood: Prior to termination of dosing
- Animals fasted: Yes, overnight
CLINICAL CHEMISTRY: Yes, alanine aminotransferase, glucose, albumin, inorganic phosghorus, aspartate aminotransferase, potassium, calcium, sodium, chloride, total bilirubin, creatinine, total protein, ganrna glutamyltransferase, urea nitrogen
- Time schedule for collection of blood: Prior to termination of dosing
- Animals fasted: Yes, overnight
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER:
-Organ weights of adrenals, testes with epididymides, kidneys, thyroid (with parathyroids), liver (with gallbladder drained) - Sacrifice and pathology:
- GROSS PATHOLOGY: external surface of the body, all orifices, cranial cavity, carcass, external surfaces of the brain and spinal cord and the cut surfaces of the spinal cord (at necropsy); the cut surfaces of the brain were examined at the time of tissue trimming nasal cavity and nasal turbinates, thoracic, abdominal and pelvic cavities and their viscera, cervical tissues and organs
HISTOPATHOLOGY: adrenals, aorta, brain with brainstem, (medulla/pons, cerebellar cortex, and cerebral cortex), cecum, colon, rectum, cervical spinal cord, duodenum, jejunum, iIeum, esophagus, eyes, gallbladder, heart, kidneys, lesions, liver, lumbar spinal cord, lung (with mainstem bronchi), mammary gland, mesenteric lymph node
mid-thoracic spinal cord, ovaries, pancreas, pituitary, prostate, salivary glands (mandibular), sciatic nerve wi h skeletal muscle, spleen,sternum with bone marrow, stomach, testes with epididymides, thymus, thyroid (parathyroids), trachea, urinary bladder, uterus with vagina and cervix - Other examinations:
- Detailed physical examinations performed weekly
- Statistics:
- Group comparisons were analyzed at the 5% two-tailed probability level.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- no adverse effects
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- no adverse effects
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- no adverese effects
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
All animals survived until terminal sacrifice. Apparent treatment-related changes noted in the 100mg/kg bw/day group males and/or females consisted of an increased incidence of salivation and emesis. In addition, soft feces, noted with mucus alone or mucus and bile-like material, were noted with a greater incidence in the high-dose animals.
BODY WEIGHT AND WEIGHT GAIN
Statistical evaluation of mean absolute body weights and mean body weight gain values failed to reveal any significant differences when treatment groups were compared to respective control values.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Statistical evaluation of mean total food consumption values failed to reveal any significant differences when treatment groups were compared to respective control values.
OPHTHALMOSCOPIC EXAMINATION
There were no apparent compound-related ophthalmoscopic changes observed at termination.
HAEMATOLOGY
Statistical evaluation of clinical hematology values revealed a significantly elevated mean erythrocyte value in the 100 mg/kg bw/day group females.
Although the statistical significance was noted, the 100 mg/kg bw/day group female mean value is within the historical control range; therefore, the significance appears to be associated with an unusually low mean control value. The toxicological relevance of this finding is questionable.
CLINICAL CHEMISTRY
Statistical evaluation of mean blood chemistry values revealed an elevated alanine aminotransferase value in the 100 mg/kg bw/day group females, elevated mean calcium values in the 30 and 100 mg/kg bw/day group females, and a depressed mean blood urea nitrogen value in the 30mg/kg bw/day group males. In regard to the calcium and blood urea nitrogen values, the relatively low magnitude of change in the calcium value and the absence of a dose response for the urea nitrogen value also lend question as to their biological significance.
ORGAN WEIGHTS
Statistical evaluation of organ weight values failed to reveal any significant differences when the absolute or relative organ weights were compared to respective control values.
GROSS PATHOLOGY
There were no gross necropsy findings which were considered to be related to treatment with ATMER 163. Those observations which were noted were of the type commonly observed in this species of dog at this laboratory.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histomorphologic examination of protocol-specified tissues revealed an increased incidence of pigment accumulation in the Kupffer cells and bile canaliculi in the livers of the Group 4 females. There were no other apparent compound-related tissue changes noted.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: tissue alterations in the liver of females at 100 mg/kg bw/d
- Dose descriptor:
- NOAEL
- Remarks:
- local
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects up to the limit dose of 100 mg/kg bw/d
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Based on the data generated from this study, the no-observable-adverse-effect level NOAEL of Atmer 163 when administered via capsule for approximately 13 weeks to male and female beagle dogs is 100 mg/kg bw/day for local effects and 30 mg/kg bw/d for systemic effects.
Applicant's summary and conclusion
- Conclusions:
- CLP: not classified
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