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Toxicological information

Basic toxicokinetics

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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

Referenceopen allclose all

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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
5 (for the analytical investigations)
Control animals:
yes
Positive control:
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.

Applicant's summary and conclusion