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Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: other route
Type of information:
other: K3/K4 Studies
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
other: K3/K4
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Though K3/K4 studies were evaluated and scored for reliability, robust summaries and unique IUCLID endpoint study records were not developed for such. Rather, a summary table of K3 and K4 studies evaluated and scored for this endpoint is provided in the field, "Any other information on results and tables" for informational purposes.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Protective effect of Dunaliella sp., lipid extract rich in polyunsaturated fatty acids, on hepatic and renal toxicity induced by nickel in rats.
Author:
Dahmen-Ben Moussa I, Bellassoued K, Athmouni K, Naifar M, Chtourou H, Ayadi H, Makni-Ayadi F, Sayadi S, El Feki A, Dhouib A.
Year:
2016
Bibliographic source:
Toxicol Mech Methods. 2016;26(3):221-30.
Reference Type:
publication
Title:
Sub-acute nickel exposure impairs behavior, alters neuronal microarchitecture, and induces oxidative stress in rats’ brain
Author:
Ijomone OM, Okori SO, Ijomone OK, Ebokaiwe AP
Year:
2018
Bibliographic source:
Drug and Chemical Toxicology 41(4):377-384

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel chloride
EC Number:
253-399-0
EC Name:
Nickel chloride
Cas Number:
37211-05-5
Molecular formula:
NiCl2
IUPAC Name:
nickel(2+) dichloride

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Data Source  Study Design and Findings  Reliability
Dahmen-Ben Moussa I, Bellassoued K, Athmouni K, Naifar M, Chtourou H, Ayadi H, Makni-Ayadi F, Sayadi S, El Feki A, Dhouib A.
The researchers treated rats with 5 mg/kg/d nickel chloride via i.p. injection for 30 days and examined antioxidant stress markers in the kidney and liver, and protection by antioxidants.

K3:  Does not meet important study design criteria (route of administration)

Ijomone et al (2018). Sub-acute nickel exposure impairs behavior, alters neuronal microarchitecture, and induces oxidative stress in rats’ brain. Drug and Chemical Toxicology; 41(4):377 -384.

 

This study investigated the behavior and histopathological alterations in the brains of rats exposed to 5, 10 or 20 mg/kg nickel chloride, through intraperitoneal injection for 21 days. Treatment with nickel significantly increased mortality at 20 mg/kg, as three deaths occurred in the third week of treatment.

K3: Does not meet important study design or analytical criteria. Irrelevant route of exposure - intraperitoneal injection.

 

Applicant's summary and conclusion

Executive summary:

Study rated by an independent reviewer