Registration Dossier
Registration Dossier
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EC number: 232-104-9 | CAS number: 7786-81-4
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- 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:
- 1 977
- 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
- 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
Constituent 1
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.
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