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EC number: 269-052-1
CAS number: 68186-90-3
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77310.
The NOAEL of >= 500 mg/kg bw/day (highest
dose) was chosen from the oral 90-day key study (Bomhard et al., 1982).
The NOAEC of >= 60 mg/m3 (highest
concentration) with a clearance half-life of 50 days in the lungs was
taken from the 5-day inhalation key study (BASF AG, 33I0110/91008,
Assessment: dermal pathway not relevant due
to lack of bioavailability.
In males and females the Sb concentrations
in liver and kidney were below the detection limit at doses up to 1000
ppm. In the high dose groups the Sb levels slightly increased with
exposure duration and reached max. 27 ppb in the liver (3 months) of
males (range 15-40 ppb) and 17 ppb in females (kidney 14 ppb in males
and 15 ppb in females).
No measurable effect on chromium content of
liver and kidney at any dose level and exposure duration.
CONTENT OF Ni AND Sb in:
LIVER: Mean Sb
concentration (quantification limit 0.2 ng/g) in unexposed animals was
1.1 ng/g; directly post-exposure and on day 3-post-exposure the
concentration was about 4-fold higher in exposed animals, and during
later observation the concentration was similar to unexposed animals
(1.3 ng/g on day 10). Mean Ni-concentration was in the same range in
exposed and unexposed animals (however, below the quantification limit
of 10 ng/g; outliers not considered).
KIDNEYS: Mean Sb
concentration in unexposed animals was below the detection limit (1
ng/g), in exposed animals it was above the detection limit but below the
quantification limit (3 ng/g), only the day 3 post exposure group
reached a value of 5.6 ng/g (2-3-fold increase compared with other
observation days). Mean Ni concentration was below the detection limit
(1 ng/g) in unexposed animals and above detection limit but below
quantification limit (25 ng/g) in exposed animals, except on day 3
post-exposure 94 ng/g were determined (10-fold more than in other
exposure groups. Authors comment: presumably due to contamination of the
sample). LUNG: Directly
post-exposure the mean Ni and Sb concentration was 79 and 202 µg/lung ,
respectively (corresponding to 2 mg of pigment/lung). The concentration
declined during the post-exposure period, following first order
kinetics; the clearance half-life was 50 days.
For the oral exposure pathway a valid
subchronic study was performed in rats.
In a subchronic study performed similar to
OECD guideline 408, male and female Wistar rats were treated with 0.5,
5, 50 and 500 mg/kg bw/d for 90 d (Bomhard et al., 1982). No substance
related effects on mortality, clinical signs, body weight, hematology,
clinical chemistry, organ weights, gross pathology and histopathology
were observed. There were no indications for bioavailability.
For the inhalative exposure pathway a valid
subacute study was performed in rats only with an analogous substance,
the nickel rutile. In a GLP-compliant bioavailability study, male Wistar
rats were exposed for 5 d to 60 mg/m3 of the test substance; the
observation period was 0, 3, 10, 31 and 60 d (BASF AG, 33I0110/91008,
1994). No effects on mortality, clinical signs, body weights and body
weight gains were found. Clearance half time was approximately 50 days
in the lung. The study was not able to demonstrate bioavailability after
inhalation of the test substance.
No leaching of metal ions in artificial sweat
solution was detected in a leaching study (see chapter 7.9.3).
Therefore, the dermal exposure pathway is considered as not relevant.
The study data on oral and inhalation
exposure reveal no treatment related adverse effects in any study. The
investigation of the dermal pathway was not considered relevant due to
the lack of bioavailability.
The available experimental test data are
reliable and suitable for classification purposes under Regulation (EC)
No 1272/2008. As a result the substance does not need to be classified
and labelled for repeated dose toxicity under Regulation (EC) No
1272/2008, as amended for the ninth time in Regulation (EC) No 2016/1179.
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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