Registration Dossier
Registration Dossier
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EC number: 485-430-0 | CAS number: 923954-49-8
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The test substance is an orange solid with a particle size of about 0.5 micrometer (d(0.1)) to 4 micrometer (d(0.9)).
The test substance has a relative density of D =4.950 at 20 °C and does not melt between 35 and 590 °C. Its vapour pressure is < 10(-6) hPa at 20°C. It is almost insoluble in water (<0.5 mg/L at
20°C ( 0.1 °C) as well as in 1-octanol (< 16 mg/L).
In an acute oral toxicity study in rats (dose level: 5000
mg/kg body weight (bw)) no signs of toxicity were observed,
giving no indication of oral bioavailability of the test
substance (ARC, 2007). In an acute inhalative toxicity
study in rats (BASF, 2008; dose
level: 5.7 mg/L, dust inhalation), clinical signs of
toxicity were visually increased respiration and a squatting
posture occurring from hour 1 of exposure through the study
day 1. Cross necropsy after the post-exposure observation
period of 14 days yielded in diffuse red discoloration of
the lung as well as in retraction and interstitial oedema.
Local effects were found in histopathological examinations
(e.g. intra-alveolar histocytosis, and pigment loaded
macrophages). These data demonstrate the local availability of the the
test substance particles when the material is inhaled.
In a 28-day gavage study in rats (BASF, 2008) with doses up
to 1000 mg/kg bw/day, no signs of toxicity were observed. Also no
effects were observed in the screening study for toxicity to
reproduction (OECD 421).
Discoloured feces (orange) was observed in all rats of
both sexes of the 300 mg/kg bw and the 1000 mg/kg bw dose
group, indicating an excretion of the test substance via feces.
There were no treatment-related changes
in the urine analysis and in the histopathological
examinations. Based on these findings,
there is no indication of an oral uptake of the test
substance. Therefore the oral bioavailablity can be
considered to be very low.
Due to its very low bioavailability, accumulation of the test
substance is not expected.
Studies on genotoxicity and sensitization were negative.
Hence, there is no indication of a reactivity of the test
substance with biomacromolecules under the chosen test conditions.
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.
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