Chrome antimony titanium buff rutile

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally acceptable scientific principles

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Subchronic Oral Toxicity and Analytical Studies on Nickel Rutile Yellow and Chrome Rutile Yellow with Rats

Author:

Bomhard E. et al.

Year:

1982

Bibliographic source:

Toxicol. Letters, 14, 189-194

Reference 2

Reference Type:

secondary source

Title:

C.I. Pigment Brown 24

Author:

OECD

Year:

2002

Bibliographic source:

SIDS Initial Assessment Report for SIAM 15

Materials and methods

Objective of study:

distribution

other: toxicity effects

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 408

Deviations:

yes

Remarks:

Levels of chromium and antimony in liver and kidneys, respectively, were measured after 1 and 2 months.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Chrome antimony titanium buff rutile

EC Number:

269-052-1

EC Name:

Chrome antimony titanium buff rutile

Cas Number:

68186-90-3

Molecular formula:

(Ti, Sb, Cr) O2

IUPAC Name:

manganese(4+) trititanium(4+) pentaantimony(3+) chromium(3+) nickel(2+) octadecaoxidandiide

Constituent 2

Reference substance name:

Reference substance 001

Details on test material:

- Molecular formula: Cr Sb Ti O
- Analytical purity: technical grade
- Composition of test material, percentage of components: molarity based: Ti 0.94, Sb 0.03, Cr 0.03; weight based: TiO2 85%, Sb2O5 10%, Cr2O3 5%

Radiolabelling:

no

Test animals

Species:

rat

Strain:

other: SPF-derived Wistar TNO W74

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 4-5 weeks
- Housing: macrolon cages
- Individual metabolism cages: no
- Diet (e.g. ad libitum): Altromin
- Water (e.g. ad libitum): tap water


ENVIRONMENTAL CONDITIONS
- reported as "standard conditions"

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on exposure:

DIET PREPARATION
- : Mixing appropriate amounts of powdered food with test substance

Duration and frequency of treatment / exposure:

90 day(s)

Doses / concentrations

Remarks:

Doses / Concentrations:
10, 100, 1000, 10000 ppm in the diet (0.5, 5, 50, 500 mg/kg bw/day) for males and females

No. of animals per sex per dose / concentration:

5 (for the analytical investigations)

Control animals:

yes

Positive control reference chemical:

no

Details on dosing and sampling:

- Tissues sampled: liver, kidneys
- Time and frequency of sampling: monthly
- Analytic method: AAS (detection limits were 5 ppb for antimony and 2 ppb for chromium)

Statistics:

Data on weight determinations, hematology and clinical chemistry were compared by Wilcoxon U-test, level of significance p<=0.05.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on distribution in tissues:

CHEMICAL ANALYSIS
Antimony: In males and females the Sb concentrations in liver and kidney were below the detection limit at doses up to 1000 ppm. In the high dose groups the Sb levels slightly increased with exposure duration and reached max. 27 ppb in the liver (3 mo) of males (range 15-40 ppb) and 17 ppb in females (kidney 14 ppb in males and 15 ppb in females).
Chromium: No measurable effect on chromium content of liver and kidney at any dose level and exposure duration.