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EC number: 231-743-0
CAS number: 7718-54-9
SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
Male and female B6C3F1 mice were obtained from Simonsen Laboratories, Gilroy, CA, USA. Groups of 20 mice (10 males + 10 females) were
individually housed and provided food and water ad libitum, except during exposure. 7-week old mice were exposed to the test substance via whole
body inhalation chambers. Chambers were maintained at a temperature of 19.1-27.6 deg. C, a relative humidity of 43-76%, and a 12-h light/dark photo cycle.
The test compound was generated from aqueous solutions (62.1 g/L in distilled and deionized water) and atomized. The aerosol was mixed with
additional dilution air to achieve the proper concentration and flow rate.
Nickel sulfate hexahydrate concentrations tested were: 0, 0.12, 0.25, 0.5, 1 or 2 mg/m3 (equivalent to 0, 0.027, 0.056, 0.11, 0.22, or 0.44 mg Ni/m3).
Animals were observed twice daily. Body weight and clinical observations were conducted at the start of the study, weekly during the study, and at
the end of the study period.
Necropsy was performed on all animals. The following organs were weighed at necropsy: brain, heart, right kidney, liver, lung, right testis, and thymus.
Hematology parameters measured: hematocrit, hemoglobin, erythrocytes, mean erythrocyte volume, mean erythrocyte hemoglobin concentration,
reticulocytes, total leukocytes, and differential and nucleated erythrocytes.
Complete histopathology was performed on mice in the 0 and 2 mg/m3 dose groups. Gross lesions and tissues examined included: adrenal gland,
bone, brain, epididymis or oviduct, gallbladder, esophagus, heart, large intestine (including cecum, colon, rectum), small intestine (including
duodenum, jejunum, ileum), kidneys, larynx, liver, lung, lymph nodes, mammary gland, nose, ovary, pancreas, parathyroid gland, pituitary gland,
prostate, salivary gland, seminal vesicle, skin, spleen, stomach, testis, thymus, thyroid gland, trachea, urinary bladder, and uterus.
The following organs were examined from selected groups of mice: lung, nose, respiratory tract, and lymph nodes (bronchial and mediastinal).
Sperm samples were collected from male mice exposed to 0, 0.5, 1, and 2 mg/m2 for evaluation (sperm density, morphology, and motility). The
right epididymis, right caudae, and right testis were weighed. Vaginal samples were collected from all female mice exposed to 0, 0.5, 1, and 2
mg/m3 for vaginal cytology evaluations (frequency of estrous stages and estrous cycle length).
Additionally, tissue burden studies were conducted on 5 or 6 male and female mice exposed to 0, 0.12, 0.5, or 2 mg/m3. Samples of lung and
kidney tissues were collected and analyzed for nickel content.
The probability of survival was estimated by the product-limit procedure of Kaplan and Meier (1958). Dose-related effects were analyzed using
Cox's (1972) method for testing two groups for equality, and Tarone's (1975) life table test to identify dose-related trends. Organ and body
weight data were analyzed using the parametric multiple comparison procedures of Dunnett (1955) and Williams (1971, 1972).
Survival (number of animals surviving/total number tested), by dose level tested:
0 mg/m3: 6/10 males, 7/10 females
0.12 mg/m3: 8/9 males, 10/10 females
0.25 mg/m3: 10/10 males, 10/10 females
0.5 mg/m3: 10/10 males, 10/10 females
1 mg/m3: 10/10 males, 10/10 females
2 mg/m3: 10/10 males, 10/10 females
Final mean body weights and body weight gains of surviving mice were not significantly different from the control group.
No significant differences in sperm morphology or vaginal cytology was found between exposed mice and control mice.
Absolute and relative lung weights were significantly increased in male mice at 1 and 2 mg/m3 and in female mice at 2 mg/m3. There were no other significant
differences in relative or absolute organ weights.
There were no significant hematology changes in male mice exposed to the test substance. In female mice, the following hematology changes were significant:
-increased hemoglobin concentration at 1 and 2 mg/m3
-increased leukocytes at 1 and 2 mg/m3
-increased segmented neutrophils at 0.5, 1, and 2 mg/m3
-increased lymphocytes at 1 and 2 mg/m3
-increased nucleated erythrocytes at 2 mg/m3
There was an exposure-related increase in histopathologic lesions (alveolar macrophage, hyperplasia) present in the lungs of male and
female mice; significant at 0.5, 1, and 2 mg/m3. Incidences of interstitial infiltrate, chronic active inflammation, and atrophy of the
olfactory epithelium were significant in male and female mice exposed to the test substance at 2 mg/m3. In female mice, hyperplasia of the
bronchial lymph node and fibrosis of the lung was significant at 2 mg/m3.
No treatment related histopathological changes were found in male and female mice exposed to 0.12 or 0.25 mg/m3.
The nickel concentration in the lungs of 2 mg/m3 female mice was significantly higher than the control animals.
RATED BY AN INDEPENDENT REVIEWER.
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