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EC number: 234-217-9 | CAS number: 10599-90-3
- 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:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative subchronic toxicity of chlorine and monochloramine in the B6C3F1 mouse.
- Author:
- Daniel F.B, Ringhand H.P., Robinson M., Stober J.A., Olson G.R., and Page N.P.
- Year:
- 1 991
- Bibliographic source:
- Journal (American Water Works Association) Vol. 83, No. 11, Health Effects (NOVEMBER 1991), pp. 68-75
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- No satellite group. The wet weight of Epididymides and uterus were not taken.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Chloramide
- EC Number:
- 234-217-9
- EC Name:
- Chloramide
- Cas Number:
- 10599-90-3
- Molecular formula:
- ClH2N
- IUPAC Name:
- chloranamine
- Test material form:
- other: in aqueous solution
- Details on test material:
- - Substance type: formulation
- Physical state: liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Mich.
- Age at study initiation: no data
- Weight at study initiation: 23.9 to 24.6 g for males/ 19.1 to 19.5 g for females
- Fasting period before study: no
- Housing: 5 animals per cage
- Diet : ad libitum (Purina certified Chow 5002, Ralston-Purina Co., St Louis, Mo)
- Water: ad libitum (tap water)
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 40- 60
- Air changes (per hr): no data
- Photoperiod : 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: carbonate buffer
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Monochloramine stock solutions (about 3,500 ppm) were prepared by adding 50 ml of the stock chlorine solution to 500 ml of distilled water. This solution was added slowly to 400 ml of distilled water containing 5 ml of concentrated ammonium hydroxide and 2 ml of 6N hydrochloric acid. The actual dosing solutions were prepared by diluting the stock monochloramine solution with pH 9.4 carbonate buffer. Because stability studies indicated that monochloramine solutions undergo at 7 to 10 percent decomposition over a period of three days at room temperature, the actual drinking water solutions were prepared at a concentration 10 percent desired, i.e., 15, 22, 55, 110, and 220 mg/l. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of the monochloramine concentration by the DPD method showed that the 220 mg/l solutions averaged 190 +/- 7 mg/l when the bottles were removed from the animal cages after three days, thus confirming the previously determined decomposition rates. Similar levels of loss were observed for the lower concentrations of monochloramine.
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 12.5, 25, 50, 100 and 200 mg/l (0, 2.5, 5, 10, 20 and 40 mg/kg/d)
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: The planned dosage levels had been selected based on previous studies conducted by the authors' laboratory and at the National Toxicology Program laboratories and were projected from the concentrations of chemical added to the drinking water and normal drinking water consumption.
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: Body weughts were recorded at the initiation of the study, weekly during exposure, and at the time of necropsy.
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Water consumption was determined three times a week.
OPHTHALMOSCOPIC EXAMINATION: Yes / No / No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood samples were collected via cardiac puncture prior to sacrifice.
- Anaesthetic used for blood collection: Yes (60 mg/kg of pentobarbital)
- Animals fasted: No data
- How many animals: 10 males and 10 females per dose level
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Blood samples were collected via cardiac puncture prior to sacrifice.
- Animals fasted: No data
- How many animals: 10 males and 10 females per dose level
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes / No / No data
- Time schedule for examinations:
- Dose groups that were examined:
- Battery of functions tested: sensory activity / grip strength / motor activity / other:
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- None
- Statistics:
- The standard statistical procedure used was a one-factor analysis of variance (ANOVA) for normally distributed measures. Males and females were considered separately in all statistical analyses, and the parameters analyzed were body weight, organ weights, organ-to-body weight ratios, water and food consumption, hematology, and clinical chemistry measurements. The differences between the control and treatment groupswere analyzed pairwise using an ANOVA contrast prodecure at an adjusted significance level to control the false positive rate (overall alpha = 0.05). Because of the high variability of some of the clinical chemistry measures, a nonparametric analysis of variance, i.e., the Kruskal-Wallis test, was also employed to determine differences among the dosage groups and to compare pairwise each dosage group to the control group. analyses of the gross and microscopic pahtology diagnoses are limited to descriptive statistics.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The body weight gains were significantly depressed at the three highest concentrations in males and the two highest concentrations in females.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- food consumption was decreased in both males and females, and the change was significant for the females at the two highest concentrations.
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No animals died during the study. Toxic effects were not evident during routine cage-side examination.
BODY WEIGHT AND WEIGHT GAIN
The body weight gains were significantly depressed at the three highest concentrations in males and the two highest concentrations in females.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Food consumption was decreased in both males and females, and the change was significant for the females at the two highest concentrations.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
Significant differences were alsoobserved in the water consumption of males at the two highest concentrations and of females at all monochloramine concentrations.
HAEMATOLOGY
A variety of changes in hematology was observed, although no effect was determined to be consistently treatment or dosage-related. The most consistent effects in both sexes were increased WBCs. In males an increase in lymphocytes at 100 and 200 mg/l and in females a decrease in neutrophils at 100 mg/l and a significant decrease in MCV at all dosage levels were the most remarkable changes.
CLINICAL CHEMISTRY
Several minor changes in clinical chemistries were noted, with no consistent treatment-related pattern. ALK-P was decreased in males at all concentration (significant at 25, 50, and 100 mg/l), whereas AST was significantly increased in females at all dosage levels (significant at 50 and 200 mg/l). LDH was significantly decreased at 25 mg/l in males but was significantly increased at 200 mg/l.
ORGAN WEIGHTS
Compared with the controls, numerous significant reductions in absolute organ weights were evident in the male and female animals drinking 200 mg monochloramine/l, with lesser effects seen for the lower concentrations. For example, for both males and females, liver and heart weights were decreased at the top two concentrations, and spleen weights (relative and absolute) were decreased at the two high dosages for females. At the highest dosage, the kidney and lung weights were decreased for both males and females, and absolute testes and spleen weight, some organs - brain, kidney, lung, and testes (males) and brain and kidney (females) - were significantly increased at the higher dosages compared with the control values.
GROSS PATHOLOGY
No compound-reated gross or microscopic lesions were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
No target tissues were identified in monochloramine-treated animals, and all lesions observed were interpreted as either agonal changes or incidental background findings.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 8.5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Decreased organ weights
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, no treatment-related pathology was observed.
- Executive summary:
Separate groups of male and female B6C3F1 mice were administered monochloramine in drinking water for 90 consecutive days. Monochloramine was supplied at 12.5, 25, 50, 100, and 200 mg/L. Criteria evaluated included mortality, clinical signs, body weight, food consumption, hematology, clinical chemistry, organ weights, gross pathology, and histopathology. Overall, the correlation of the biochemical, hematological, and organ weight data, in the absence of histopathology and observable clinical signs of toxicity, suggests that the monochloramine induced effects via an indirect mechanism, e.g., nutritional deficiencies, rather than a direct toxicological effect on specific organs or tissues.
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