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EC number: 231-743-0
CAS number: 7718-54-9
Value used for CSA
(read-across from Nickel sulphate):
systemic, animal): 10 mg Ni sulphate hexahydrate /kg bw/day (or 2.2 mg
Ni/kg bw/day) (Heim et al. 2007)
local, animal): 0.12 mg Ni sulphate hexahydrate /m³ air ( or 0.027 mg
Ni/m3 air) (Dunnick
et al., 1995)
0.25 mg nickel sulphate hexahydrate/m3 (or 0.056 mg Ni/m3)
Four animal studies have been found which
describe toxicity in relation to repeated oral exposure during 28 days,
77 days, 92 days, or 25 weeks. In two of these studies nickel chloride
was given in drinking water, in one study nickel chloride was added to
the food, and in one study dosing was by gavage. All of these studies
suffer from various limitations in design and reporting. The most
comprehensive study was the 91-day gavage study, which however suffered
from a high mortality and a high number of fatalities caused by gavage
errors. Furthermore, gavage dosing may in this case be less relevant
than exposure via drinking water or food in relation to human exposure.
In addition to mortality, the animals exhibited salivation, lethargy,
and irregular breathing, and decreased body weight. The LOAEL was 5 mg
Ni/kg bw/day based on mortality. This was the lowest dose level in the
study. In the 25-week drinking water study no toxicity was observed at
the single dose level studied, 10.2 mg Ni/kg bw/day, however, only a
limited number of endpoints were studied. In the 77-day dietary study,
no general toxic effects were found at 10 or 20 mg Ni/kg bw/day, however
the group size was only 6, and the number of endpoints studied was
limited. At 20 mg/kg bw/day, effects in an operant task were observed,
thus the NOAEL was 10 mg/kg bw/day. In the 28-day drinking water study,
body weight gain was reduced at all dose levels with a LOAEL of 0.01 mg
Ni/kg bw/day, however, the limitations in reporting makes it difficult
to interpret the findings in terms of biological significance. In
conclusion, although several studies of repeated dose oral toxicity of
nickel chloride have been found, none are considered adequate for the
determination of a NOAEL.
Data regarding repeated toxicity of Ni
chloride via oral exposure are read-across from Ni sulphate. In
addition, a summary document on the read-across assessment and systemic
oral toxicity of nickel compounds can be found as a background document
in Appendix B1 of the CSR (Section 7.5.1 of IUCLID). In
a 2- year OECD 451 carcinogenicity study, decreased body weight gain
ranging from 4% to 12% was recorded (male and female rats combined)
following oral gavage of 2.2 to 11 mg Ni/kg bw/day. A dose-related
reduced survival achieving statistical significance at the two highest
dose levels was seen in females (Heim et al., 2007). The LOAEL of 6.7 mg
Ni/kg bw/day based on reduced body weight and increased mortality
together with a NOAEL of 2.2 mg Ni/kg bw/day are taken forward to the
risk characterisation for oral repeated dose toxicity. These data are
considered relevant for the risk assessment of nickel chloride and are
taken forward to the Risk Characterisation.
Inhalation of nickel chloride (0.2-0.6 mg Ni/m3
for up to 8 months) causes adverse effects on lung macrophages in
rabbits. The LOAEC for local lung effects is 0.2 mg Ni/m3,
which corresponds to roughly 0.8 mg NiCl2.6H2O/m3.
No animal studies of systemic effects
following repeated inhalation of nickel chloride have been found. A
single occupational study has been found, indicating kidney effects in
humans at high exposure levels, however, the exposure information is
insufficient for risk characterisation.
From the background document on nickel
compounds it appears that long-term inhalation of insoluble as well as
soluble nickel compounds results in adverse effects on the lungs
including chronic inflammation and fibrosis. Read-across to other nickel
compounds shows that the rabbit LOAEC identified for nickel chloride is
higher than the lowest LOAEC which has been found for nickel sulphate in
studies in rats. Nickel chloride has not been studied in a comprehensive
chronic toxicity study.
Data for repeated-dose toxicity via
inhalation exposure are read-across from Ni sulphate. Chronic lung
inflammation including lung fibrosis results from long-term exposure (2
year) via inhalation to a concentration of 0.056 mg Ni/m3 or
0.25 mg nickel sulphate hexahydrate/m3 (NTP, 1996a; Dunnick
et al., 1995). Nickel sulphate fulfils the criteria for classification
as STOT RE 1; H372 since chronic lung inflammation including lung
fibrosis results from long-term exposure via inhalation to a
concentration of 0.056 mg Ni/m3. A
LOAEC for repeated dose toxicity via inhalation of 0.056 mg Ni/m3 for
lung inflammation and fibrosis, and a NOAEC of 0.027 mg Ni/m3 for
these effects based on the chronic study of nickel sulphate by NTP, are
used in the risk characterization of nickel chloride.
Chronic lung inflammation and lung fibrosis
are serious and potentially irreversible effects. Based on data from
other nickel compounds, supported by the nickel chloride-specific data
on macrophage effects in rabbits, nickel chloride is classified as STOT
RE 1; H372 with a specific concentration limit of ≥ 1% in the 30th ATP.
The following information is taken into
account for any hazard / risk assessment:
ORAL: Data are read-across from Ni sulphate.
A 2-year oral carcinogenicity study reported a NOAEL of 10 mg/kg body
weight/day (2.2 mg Ni/kg b. w. /day) and a LOAEL of 30 mg/kg body
weight/day (6.7 mg Ni/kg b. w. /day). The LOAEL of 6.7 mg Ni/kg bw/day
based on reduced body weight and increased mortality together with a
NOAEL of 2.2 mg Ni/kg bw/day is taken forward to the risk
characterisation. A summary document on this topic is provided as a
background document in section 7.5.1 of IUCLID and in Appendix
B1of the CSR.
INHALATION: Data are read-across from Ni
sulphate. Chronic lung inflammation including lung fibrosis results from
long-term exposure via inhalation to a concentration of 0.056 mg Ni/m3
or 0.25 mg nickel sulphate hexahydrate/m3 (LOAEC).
Nickel sulphate fulfils the criteria for classification as STOT RE 1;
H372. A concentration of 0.027 mg Ni/m3 (MMAD = 2.5 µm)
corresponding to the NOAEC for respiratory toxicity effects in rats is
taken forward for the risk characterisation.
There was no available information to determine a NOAEL/LOAEL for the
dermal route. Testing by the dermal route has been waived as described in
IUCLID Section 7.5.3.
Ni chloride is classified as STOT RE 1; H372
according to the 1st ATP to the CLP. Background information on this
topic can be found in the discussion section.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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