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EC number: 485-430-0
CAS number: 923954-49-8
Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 423)- inhalative: LC50 > 5.7 mg/L air (OECD 403)
The acute oral toxicity was evaluated in a
study performed under GLP according to OECD guideline 423, where three
female Crl:(WI)BR rats were treated with a dose of 5000 mg/kg bw by
gavage (BASF, 2007). Since no toxic effects and no mortality were noted
during the entire 14 day observation period, the LD50 was found to be
>5000 mg/kg bw/day.
For analyzing the acute inhalative toxicity,
a study with five male and five female Wistar rats was performed under
GLP according to OECD guideline 403 (BASF, 2008). The animals were
exposed to a dust-aerosol at a concentration of 5.7 mg/L air with
head/nose only for 4 hours. Although clinical signs of toxicity
comprised visually increased respiration and squatting posture were
observed on the first day, no lethality occurred within the 14 day
All animals underwent gross necropsy after
the post-exposure observation period of 14 days. Subsequent pathology
revealed diffuse red discoloration of the lung, moderate retraction of
the lung tissue and moderate to severe interstitial edema, whereas the
histopathological examination of the lungs of one male and one female
animal revealed moderate to severe acute diffuse congestion, moderate to
severe diffuse intra-alveolar histiocytosis with numerous pigment-loaded
macrophages and minimal to moderate multifocal interstitial
lymphoplasmahistiocytic infiltrates. However, based on the survival of
all animals, the LC50 was >5.7 mg/L air.
In a further study (Rockwood Pigments UK
Ltd, 2014) it was impossible to generate a test atmosphere from the test
item. Therefore, it was not possible to proceed to a formal exposure.
Classification, Labeling, and
Packaging Regulation (EC) No 1272/2008
The available data for acute toxicity are
reliable and suitable for classification purposes under Regulation (EC)
No 1272/2008. Based on this data, the substance is not considered to be
classified for acute toxicity) under Regulation (EC) No 1272/2008, as
amended for the twelfth time in Regulation (EU) 2019/521.
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