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
Key value for chemical safety assessment
Effects on fertility
Additional information
In a GLP compliant study performed with C.I. Pigment Yellow 53 (CAS no.8007-18-9) as an analogous substance which shares the property of very low water solubility, according to OECD guideline 422, CD rats were administered orally 250, 500 or 1000 mg/kg bw/day for 46 d (males) or 41-45 d (females; MHLW 2002). The substance did not cause any significant effect on fertility in both P and F1 animals.
In a subchronic study performed with C.I. Pigment Yellow 53 (CAS no.8007-18-9) similar to OECD guideline 408, male and female Wistar rats were treated with 0.45, 4.5, 45 and 450 mg/kg bw/day for 90 d (Bomhard et al. 1982). No substance related effects on reproduction organs were found.
Additionally, there are no indications for bioavailability since the substance showed no bioavailability after oral and inhalative exposure. Additionally, no leaching of metal ions was detected in a leaching study (see water solubility section). No hazard is expected for the dermal exposure pathway. Therefore, additional studies for reproduction and developmental toxicity are not considered necessary.
Short description of key information:
The assessment for Chrome tungsten titanium buff rutile (CAS-no. 68186-92-5; C.I. Pigment Yellow 163) is based on a read-across from the chemically closely related rutile pigment C.I. Pigment Yellow 53 (CAS no.8007-18-9)
oral
rat, 46/41-45 d (m/f): NOAEL P, F1 >= 1000mg/kg bw/ day (MHLW 2002)
rat, 90 d: NOAEL P >= 450 mg/kg bw/ day (only reproductive organs; Bomhard et al. 1982)
Assessment: not bioavailable
Effects on developmental toxicity
Description of key information
oral
rat, 46/41-45 d (m/f): NOAEL maternal, teratogenicity >= 1000mg/kg bw/ day (MHLW 2002)
Assessment: not bioavailable
Additional information
Developmental toxicity
In a GLP compliant study performed according to OECD guideline 422, CD rats were administered orally 250, 500 or 1000 mg/kg bw/ day for 46 d (males) or 41-45 d (females; MHLW 2002). The substance did not cause any significant maternal or teratogenic effect.
Additionally, there are no indications for bioavailability since the substance showed no bioavailability after oral and inhalative exposure. Additionally, no leaching of metal ions was detected in a leaching study (see water solubility section). No hazard is expected for the dermal exposure pathwayt. Therefore, additional studies for reproduction and developmental toxicity are not considered necessary.
Justification for classification or non-classification
No indications were given for a toxic potential on reproduction or development. Endpoint is not relevant for non-bioavailable substances.
Additional information
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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