Registration Dossier
Registration Dossier
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EC number: 269-054-2 | CAS number: 68186-92-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77896.
Endpoint summary
Administrative data
Description of key information
The assessment of repeated dose toxicity is based on tests conducted with two chemically closely related rutile pigments by Read-Across.
Oral
Nickel rutile (C.I. Pigment Yellow 53 (CAS no.8007-18-9))
90d rat: NOAEL >= 450 mg/kg bw/d (OECD 408, Bomhard et al. 1982)
chrome rutile (C.I. Pigment Brown 24 (CAS no. 68186-90-3))
90d rat: NOAEL >= 500 mg/kg bw/d (OECD 408, Bomhard et al. 1982)
No indications of bioavailability for both substances (Bomhard et al. 1982)
Dermal
Assessment: dermal pathway not relevant due to lack of bioavailability.
Inhalation
Nickel rutile (C.I. Pigment Yellow 53 (CAS no.8007-18-9))
rat 5 d: NOAEL >= 0.06 mg/L; clearance in the lung, no bioavailability (BASF 1994)
Key value for chemical safety assessment
Additional information
Oral
For the oral exposure pathway a valid subchronic study was performed in rats with two analogous substances (chrome and nickel rutiles, CAS Nrs. 68186-90-3 and 8007-18-9, respectively).
Nickel rutile
In a subchronic study performed similar to OECD guideline 408, male and female Wistar rats were treated with 0.45, 4.5, 45 and 450 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.
Chrome rutile
Bomhard et al. (1982) also tested chrome rutile under comparable conditions in doses of 0.5 to 500 mg/kg bw/d. Again, no effects were observed. In both studies it was shown that the tested rutile pigments are not bioavailable. The studies provide sufficient information that rutiles are not bioavailable following oral exposure.
Dermal
No leaching of metal ions was detected in a leaching study with chrome tungsten titanium buff rutile, and in the analogous nickel rutile (see water solubility section). Therefore, no hazard is expected for the dermal exposure pathway.
Inhalation
For the inhalative exposure pathway a valid subacute study was performed in rats 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 test substance; the observation period was 0, 3, 10, 31 and 60 d (BASF 1994). No effects on mortality, clinical signs, body weights and body weight gains were found. Clearance half time was ca. 50 d in the lung; bioavailability was not found in other organs.
Justification for classification or non-classification
There is no need for classification of the substance, which is considered as not bioavailable.
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