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Toxicological information

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
sub-chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Single dose

Data source

Reference
Reference Type:
publication
Title:
Biochemical and morphological changes in some organs of rat in nickel intoxication.
Author:
Mathur AK, Chandra SV, Behari J, Tandon SK.
Year:
1977
Bibliographic source:
Arch. Toxicol., 37, 159-164.

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel sulphate
EC Number:
232-104-9
EC Name:
Nickel sulphate
Cas Number:
7786-81-4
Molecular formula:
NiSO4
IUPAC Name:
nickel(2+) sulfate
Details on test material:
- Reported as Nickel sulphate hexahydrate

Test animals

Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
Source: Industrial Toxicology Research Centre.
weight: 165 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: 0.9% NaCl
Details on exposure:
30 animals were dosed daily for 90 days
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
3 mg Ni/kg
No. of animals per sex per dose:
30 males
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
Animals were weighed every 6th day.
Sacrifice and pathology:
Rats were sacrificed 48 hours after the last injection at 7, 15, 30, 60, and 90 days.
Liver, kidney, testis, and myocardium were removed and processed for histological examination.
Other examinations:
The activity of succinic dehydrogenase, oxidoreductase, adenosine triphosphate, and acid phosphatase was determined in liver, kidney and testis.
Phosphorylase was measured in myocardium only.
Protein content was also measured in all tissues.
Statistics:
Student's t-test

Results and discussion

Results of examinations

Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Details on results:
No gross pathological abnormalities were observed except for mild congestion of liver and kidney at day 60 and 90.
Microscopic changes were observed in the liver at 60 days (degenerated hepatocytes and mononuclear cells) and 90 days (Bile duct proliferation
and Kupffer cell hyperplasia). At 60 days, kindeys were congested, while at 90 days, necrosis of the proximal tubule was observed. At 60 days,
the myocardium showed necrosis, muscle fibers were fragmented and blood cells were seen between necrosed fibres.

Succinic dehydrogenase was significantly lower in the liver at 60 and 90 days, and in the kidney at 60 and 90 days.
Adenosine triphosphatase was significantly lower in the kidney at 60 and 90 days, and significantly higher in testis at 30, 60, and 90 days.
Acid phosphatase was significantly higher in liver at 90 days and lower in testis at 90 days.
Phosphorylase was significantly lower in myocardium at 90 days.


Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

STUDY RATED BY AN INDEPENDENT REVIEWER.

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