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EC number: 203-629-0 | CAS number: 108-91-8
- 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:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets the criteria of today
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Long term toxicity of cyclohexylamine hydrochloride in the rat
- Author:
- Gaunt IF, Hardy J, Grasso P, Gangolli SD, Butterworth KR,
- Year:
- 1 976
- Bibliographic source:
- Food Cosmet. Toxicol. 14, 255-267
Materials and methods
- Principles of method if other than guideline:
- dietary application of 0, 600, 2000, 6000 ppm cyclohexylamine hydrochloride to male and female rats for 2 years and observation for mortality and clinical signs determination of food and water intake, weight development, hematological and clinical chemical parameters and urinary parameters. Following death or sacrifice after termination of treatment gross and histopathological examination
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Cyclohexylammonium chloride
- EC Number:
- 225-661-4
- EC Name:
- Cyclohexylammonium chloride
- Cas Number:
- 4998-76-9
- IUPAC Name:
- cyclohexanaminium chloride
- Details on test material:
- no further details
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males: 100-165 d; females: 85-140 g
- Fasting period before study:
- Housing: in groups of 4
- Diet ad libitum
- Water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50-60
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: mixed in diet
- Details on oral exposure:
- dietary application of 0, 600, 2000, 6000 ppm cyclohexylamine hydrochloride to male and female rats for 2 years
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily in diet
Doses / concentrations
- Remarks:
- Doses / Concentrations:
600, 2000, 6000 ppm cyclohexylamine hydrochlorid corresponds to appr. 0, 18/26, 60/88, 219/321 mg cyclohexylamine /kg-bw/day (in males/females)
Basis:
- No. of animals per sex per dose:
- 48
- Control animals:
- yes
- Details on study design:
- dietary application of 0, 600, 2000, 6000 ppm cyclohexylamine hydrochloride to male and female rats for 2 years and observation for mortality and clinical signs determination of food and water intake, weight development, hematological and clinical chemical parameters and urinary parameters. Following death or sacrifice after termination of treatment gross and histopathological examination Post-exposure period: no
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- observation for mortality and clinical signs determination of food and water intake, weight development,
hematological parameters: Hb, PCV, RBC, Retics, leucocytes
and clinical chemical parameters:GOT, GPT, KDH, Glucose, urea, total protein, albumin
and urinary parameters: renal concentration and urinary cell excretion - Sacrifice and pathology:
- Following death or sacrifice after termination of treatment gross and histopathological examination
final body weight, absolute and relative weight of brain, heartm liverm spleen, kidneys, stomach small intestine, caecum, adrenals, gonads, pituitary and thyroid, histopathological lesions, incidence of tumours - Other examinations:
- no data
- Statistics:
- Chi square test, student's t-test, ranking method of White (1952)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
no clinical signs
the rats given the highest doses apear to be healthier than control animals
at week 104
death males: 600-2000-6000 ppm: 21-18-5 versus 24 of controls
death females: 600-2000-6000 ppm:10-4-7 versus 16 of controls
BODY WEIGHT AND WEIGHT GAIN
significantly reduced in all dose groups from week 2 onwards
final body weight: 600-2000-6000 ppm
males: 623g-575g-451g versus 646 g of control
females: 360g-311g- 240 g versus 399 g of controls
COMPOUND INTAKE (if feeding study)
was time-dependent reduced in all dosage groups
the average intake of cyclohexylamine hydrochloride during the experiment
males: 24, 82, 300 mg/kg bw/day
females: 35, 120, 440 mg/kg bw/day
WATER CONSUMPTION
was time dependent increased during the experiment
HAEMATOLOGY
females, 6000 ppm during the first year of the study the hemoglobin concentration reduced
by 6-8 %
at week 104 significant differences to the respective control only at the highest dose group
(males , 6000 ppm) Hb , PCV increased; reticulocytes decreased;
total leucocytes dose-dependent significant decreased in all dose groups when compared te controls
CLINICAL CHEMISTRY
males: significant changes only; 600-2000-6000 ppm
urea (mg/100 ml): 30-32-23 versus 48 in controls
albumin (g/100 ml): 3.16-3.34-4.09 versus 2.97 in controls
ORGAN WEIGHTS
males:
--absolute organ weights dose-dependent decreased heart, liver, spleen, kidneys, adrenals. gonads, thyroid
--relative organ weights (significant changes only, mg/100 g bw)
brain, 2000, 6000 ppm: 0.36, 0.48 versus 0.34 of control; liver , 6000 ppm 2.32 versus 2.65;
spleen, 6000 ppm: 0.21 versus 0.29 of controls; kidneys, 6000 ppm: 0.56 versus 0.72
females
--absolute organ weights dose dependent decreased heart, liver, spleen, kidneys, adrenals, pituitary
--relative organ weights (significant changes only; mg/100g bw)
brain, 600, 2000, 6000 ppm: 0.56, 0.65, 0.82 versus 0.50 on controls
gonads,2000, 6000 ppm: 43.8, 54.4 versus 32.6 on controls
thyroid, 2000, 6000 ppm: 9.8, 9.1 versus 7.9 on controls
GROSS PATHOLOGY , HISTOPATHOLOGY: NON-NEOPLASTIC
Many of the lesions encountered in the histopathological examination were present with a markedly lower frequency in the rats given 2000 and 6000 ppm cyclohexylamine hydrochloride than in the controls. This was particularly noticeable in the incidences of myocardial fibrosis, mild hepatic changes, hyperplasia of the parathyroids and glomeruonephrosis
Increases in the incidences of histopathological changes were restricted to the lungs where significantly more of the rats given 6000 ppm cyclohexylamine hydrochloride had alveoli with foamy macrophages and to the testes. In the latter organ the incidence of bilateral atrophy was statistically greater in the rats given 6000 ppm than in the controls. At the intermediate level (2000 ppm) there was an increase in the incidence of testes with tubules showing few or no spermatids. There were no statistically significant increases in the incidence of testicular lesiohs in rats given 600 ppm cyclohexylamine hydrochloride.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
Cyclohexylamine hydrochloride at levels up to 6000 ppm in the died did not show any carcinogenic potential
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 600 ppm
- Sex:
- male/female
- Basis for effect level:
- other: Approx. 18 mg/kg/day; body weight gain was reduced by approx. 10%. Observations on hematologic and clinical-chemistry parameters and organ weights were observed but gave no consistent picture.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
decreased rates of body-weight gain, reduced food intake,
reduced water intake; alterations of organ weights, lowered
concentrations of serum urea and higher concentrations of
serum albumin were observed in the treated rats compared
with the controls; rats given 2000 and 6000 ppm showed
testicular changes (atrophy or tubules with few spermatids)
Applicant's summary and conclusion
- Executive summary:
Male and female Wistar rats received 600, 2000, 6000 ppm Cyclohexylamine hydrochloride in the diet for 2 years.The average intake of cyclohexylamine hydrochloride during the experiment by males: 24, 82, 300 mg/kg bw/day and by females: 35, 120, 440 mg/kg bw/day. These doses correspond to 18, 60, 219 mg/kg bw/day cyclohexylamine for males and 26, 88, 321 mg/kg bw/days cyclohexylamine for females. Main findings that could be related to treatment were a slight anemia, a failure to produce normally concentrated urine, and an increase in the number of male and female animals with foamy macrophages within the alveoli among the rats given 6000 ppm. There were testicular changes in the form of atrophy or tubules with few spermatids in males increase in rel gonad-weights given 2000 and 6000 ppm (Gaunt 1976)..
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