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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Inappropriate dosing: IP Injection. No information on test material.

Data source

Reference
Reference Type:
publication
Title:
Toxicity to heavy metals and relationship to seizure thresholds.
Author:
Adler MW, Adler CH
Year:
1977
Bibliographic source:
Clin. Pharmacol. Therap. 22, 774-779.

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
not applicable

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Weight: 275-325 g
Environmental Conditions: 22 +/- 1 deg C, 50 +/- 10% relative humidity, standard 24 hr light cycle
Food and water provided ad libitum.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
I.P. Injections given once daily in a volume of 0.5 ml for 2 days

Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
not reported
Duration of treatment / exposure:
2 days
Frequency of treatment:
1 per day
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
NiSO4: 10, 30, 40, 50 mg/kg/day Ni Acetate: 10, 30, 40, 50 mg/kg/day
Basis:
nominal conc.
No. of animals per sex per dose:
8-9
Control animals:
yes, concurrent vehicle
Details on study design:
To evaluate seizures, a 10% flurothyl solution in 95% ethanol (v/v) inudcer was provided at a constant rate of infusion of 0.103 ml/min
by a Harvard infusion pump until the onset of clonic conclusion.

Examinations

Examinations:
Two tailed T-test for independent samples.
LD50 calculated by linear extrapolation

Positive control:
none reported

Results and discussion

Details on results:
Endpoint LD50: 35 — 40 mg/kg/d (Ni Sulphate)
Endpoint LD50: 35 — 40 mg/kg/day (Ni acetate)
Mortality:
NiSO4: 100% survival <=30 mg/kg/day, 8/9 died at 50 mg/kg
Ni Acetate: 100% survival <=30 mg/kg/day, 6/8 died at 40 mg/kg, 7/8 died at 50 mg/kg
Body weight: Significant reduction of body weight in the 30 mg/kg/day dose group (NiSO4 and Ni Acetate)
Other findings: Significant increase in seizure threshold at the 30 mg/kg/day dose group (NiSO4 and Ni Acetate)

Applicant's summary and conclusion

Executive summary:

STUDY RATED BY AN INDEPENDENT REVIEWER.