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EC number: 231-106-7 | CAS number: 7439-97-6
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1981-09-30 (first dose) to 1982-04-05/09 (necropsy date)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented reliable study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Six-month studies were conducted to evaluate the cumulative toxic effects of repeated exposure to mercuric chloride, since 13-week studies were not considered adequate to determine the doses to be used in the 2-year studies. Groups of 10 rats of each sex received 0, 0.312, 0.625, 1.25, 2.5, or 5 mg mercuric chloride per kg body weight in deionized water by gavage for 26 weeks.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Mercury dichloride
- EC Number:
- 231-299-8
- EC Name:
- Mercury dichloride
- Cas Number:
- 7487-94-7
- IUPAC Name:
- mercury dichloride
- Details on test material:
- - Name of test material (as cited in study report): mercuric chloride
- Molecular formula (if other than submission substance): HgCl2
- Molecular weight (if other than submission substance): 271.5
- Substance type: technical product
- Physical state: white powder
- Analytical purity: >99 %, water content >0.1 %; analysis performed by the analytical chemistry laboratory, Midwest Research Institute (Kansas City, MO).
- Impurities (identity and concentrations): no inorganic impurities were found by X-ray emission analysis. No organic impurities were detected by ultravioletbisible and NMR spectroscopies.
- Lot/batch No.: 792985
- Stability under test conditions: no bulk chemical stability studies were necessary because of the physical and chemical properties of mercuric chloride.
- Storage condition of test material:bBecause mercuric chloride is somewhat volatile at room temperature, the compound was stored protected from light in a Nalgene@' container at room temperature.
- Other: substance obtained from the Fisher Scientific Company (Fairlawn, NJ)
No further information given.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI, USA
- Age at study initiation: 43 to 50 days
- Weight at study initiation: range of mean body weights per dose group: 137- 151 g (males), 119 - 127 g (females)
- Housing: housed five per cage, polycarbonate cages with Edstrom grommets (Hazleton Systems, Inc., Aberdeen, MD), changed twice weekly; bedding: BetaChips, heat-treated hardwood chips, (Northeastern Products Corp.,Warrensburg, NY), changed twice weekly
- Diet: ad libitum, NIH-07 Open Formula Rat Ration, mash (Zeigler Bros., Inc.,Gardnels, PA)
- Water: ad libitum, Source: Village of Mattawan, MI, and IRDC wells.
- Acclimation period: 15 days before being assigned to treatment groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 73 °F, 22.8 °C (average)
- Humidity (%): 39 %
- Air changes (per hr): 6-12 changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1981-09-30 (first dose) To: 1982-04-05/09 (necropsy date)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionised
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Solutions were prepared by mixing the appropriate amount of mercuric chloride in deionized water.
- Stability studies were not conducted by the analytical laboratory, because no appropriate analytical procedures were available to differentiate between covalently bonded mercuric chloride and the potential ionic species. However, total mercury concentrations were analysed over a 3-week period.
- Dose formulations were stored protected from light at room temperature for up to 3 weeks.
- Dose formulations were prepared at least every 3 weeks.
- Amount of vehicle (if gavage): dose volume 5 mL/kg for 0, 0.312, 0.625, 1.25, 2.5, or 5 mg mercuric chloride / kg body weight. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Dose formulations were routinely analyzed throughout the studies by ultraviolet spectroscopy to determine mercury concentration. In the 6-month studies, dose formulations were analyzed prior to initiation, at mid-point, and at termination. All dose formulations analyzed were within 10% of the target concentrations.
- Duration of treatment / exposure:
- 6 months (26 weeks for males and 27 weeks for females)
- Frequency of treatment:
- 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.312 mg HgCl2/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
0.625 mg HgCl2/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1.25 mg HgCl2/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
2.5 mg HgCl2/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
5 mg HgCl2/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- Groups of 10 rats of each sex
- Control animals:
- yes
- Details on study design:
- - Route rationale: administration of mercuric chloride in water by gavage was selected as the route of exposure to ensure accurate and consistent exposure during the studies. Mercuric chloride was expected to exacerbate the naturally occurring renal disease of rodents, which increases water consumption; thus, drinking water administration was not chosen.
- Rationale for animal assignment (if not random): blocks were arranged by weight and animals were assigned to treatment groups by random numbers. - Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once weekly, all animals were examined for toxic effects and were palpated for masses.
BODY WEIGHT: Yes
- Time schedule for examinations: initially and once a week; rats were also weighed prior to special study evaluation and at study termination.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
FOOD EFFICIENCY: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at 2 and 4 months and at 6 months
- Animals fasted: No data
- Parameters checked: urea nitrogen, creatinine, sodium, potassium, chloride, calcium, phosphorus, total protein, albumin, A/G ratio, total bilirubin, acid phosphatase, alkaline phosphatase, alanine, aminotransferase, aspartate aminotransferase, lactate dehydrogenase, ornithine carbamoyltransferase, sorbitol dehydrogenase, serum cholinesterase, pH
URINALYSIS: No, only done during chronic study
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- After 6 months, all surviving animals not designated for mercury analysis were killed (CO2) and necropsied. Organ weights were determined for the brain, heart, liver, lung, right kidney, and thymus of all animals, and the right testis of all males. Average age at necropsy: 32-33 weeks.
GROSS PATHOLOGY: Yes.
HISTOPATHOLOGY: Yes. Complete histopathologic examinations were performed on all rats in the control and 5 mg/kg dose groups: adrenal gland, bone marrow, brain, clitoral gland, epididymis, esophagus, heart, kidney, large intestine, liver, lung, lymph nodes (mandibular, mesenteric), mammary gland, nose, ovary, pancreas, parathyroid gland, pituitary gland, preputial gland, prostate, testis (males), thymus, thyroid gland, trachea, urinary bladder, uterus (females), and gross lesions. Kidneys, stomach, preputial gland (males), and clitoral gland (females) were examined from rats of all dose groups. - Other examinations:
- no data
- Statistics:
- The probability of survival was estimated by the product-limit procedure of Kaplan and Meier (1958). Statistical analysis for a possible dose-related effect on survival used the method of Cox (1972) for testing two groups for equality and Tarone(’1s9 75) life table test to identify dose-related trends. The incidence of neoplasms or nonneoplastic lesions is given as the ratio of the number of animals bearing such lesions at a specific anatomic site to the number of animals in which that site was examined. Two approaches were employed to assess the significance of pairwise comparisons between dosed and control groups in the analysis of continuous variables. Organ and body weight data, which have approximately normal distributions, were analyzed using the multiple comparison procedures of Williams (1971, 1972) and Dunnett (1955). Clinical chemistry and haematology data, which typically have skewed distributions, were analyzed using the multiple comparison methods of Dunn (1964) and Shirley (1977). Jonckheere’s test (Jonckheere, 1954) was used to assess the significance of dose-response trends and to determine whether a trend-sensitive test (Williams’ or Shirley’s test) was more appropriate for pairwise comparisons than a test that does not assume a monotonic dose-response trend (Dunnett’s test or Dunn’s test). Average nephropathy severity values were analyzed for significance using the Mann-Whitney U test (Hollander and Wolfe, 1973).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- no toxicological relevant changes
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- All rats survived to study end.
BODY WEIGHT AND WEIGHT GAIN
- Effects on body weight in males and females were within 10% of controls and not regarded as adverse.
- No other biologically significant differences in body weights occurred.
CLINICAL CHEMISTRY
- At 4 months, creatine and potassium levels and alanine aminotransferase and aspartate aminotransferase activities were significantly
less than those of the controls for all dosed males.
- Effects on clinical chemistry parameters at months 4 in males were not regarded as adverse.
- No other biologically significant diffences in clinical chemistry parameters were observed
ORGAN WEIGHTS
- Effects on absolute and relative kidney weights were observed at and above 0.312 mg/kg bw/d in males and 0.625 mg/kg bw/d in females.
- No other biologically significant differences in organ weights occurred.
GROSS PATHOLOGY
- Macroscopic changes in dosed males included granular kidneys and enlargement of the parathyroid and thyroid glands
- No biologically significant changes were noted at necropsy for dosed females.
HISTOPATHOLOGY: NON-NEOPLASTIC
- Treatment-related histopathological changes (nephropathy characterized by foci of tubule regeneration, basement membrane thickening and scattered dilated tubules containing hyaline casts) were observed in males with increased severity at and above 1.25 mg/kg bw/d.
OTHER FINDINGS
- Mercury levels in kidney, liver, and brain tissues tended to increase with dose. Mercury levels were highest in the kidney and lowest in the brain. Mercury levels in males and females tended to be similar.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 0.312 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: LOAEL based on effects on kidney weights of male rats at 0.312 mg/kg bw/d (0.23 mg/kg bw/d Hg).
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Dose selection rationale: based on body weight changes and renal toxicity, the dose levels of mercuric chloride selected for administration by gavage to male and female rats for the 2 -year studies were 0, 2.5 and 5 mg/kg.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, only a LOAEL could be established based on effects on kidney weights of male rats at 0.312 mg/kg bw/d (0.23 mg/kg bw/d Hg).
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