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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral:


RA: Antimony nickel titanium rutile 90d rat: NOAEL >500 mg/kg bw/d (OECD 408, Bomhard et al. 1982); 


RA: Chrome antimony titanium buff rutile 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)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See read-across justification attached in chapter 13.2
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Dose descriptor:
NOAEL
Effect level:
> 500 mg/kg bw/day (nominal)
Based on:
other: read-across substance
Sex:
male/female
Basis for effect level:
other: no effects presumed
Critical effects observed:
no
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral


For the oral exposure pathway a valid subchronic study was performed in rats with two analogous substances (Chrome antimony titanium rutile and Antimony nickel titanium rutile, CAS Nrs. 68186-90-3 and 8007-18-9, respectively).


Antimony nickel titanium rutile


In a subchronic study performed similar to OECD guideline 408, male and female Wistar rats were treated with 0.5, 5.0, 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.


Chrome antimony titanium rutile


Bomhard et al. (1982) also tested Chrome antimony titanium 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.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result, the substance is not considered to be classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) 2018/1480 of 4 October 2018.