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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with limited documentation and acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the potential genotoxicity of chromium picolinate in mammalian cells in vivo and in vitro.
Author:
Andersson, M.A. et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45, 1097-1106

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
only one sampling time
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): chromium picolinate
- Analytical purity: analytical quality

Test animals

Species:
mouse
Strain:
other: CBA/Ca
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Scanbur BK
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: ca. 20 g
- Diet (e.g. ad libitum): standardized rodent pellet diet, batch 3386
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 7 days

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
phosphate buffered saline (PBS)
Duration of treatment / exposure:
single injection
Frequency of treatment:
once
Post exposure period:
42 h sampling time
Doses / concentrations
Remarks:
Doses / Concentrations:
0.75, 1.5 and 3 mg/kg bw
Basis:
other: administered dose
No. of animals per sex per dose:
3
Control animals:
yes, concurrent vehicle
Positive control(s):
colchicine
- Justification for choice of positive control(s): appropriate positive control for the micronucleus assay when using mice as test species (Cammerer et al. 2007, Mutagenesis 22, 129-134)
- Route of administration: intraperitoneal
- Doses / concentrations: 1 mg/kg

Examinations

Tissues and cell types examined:
peripheral blood erythrocytes (polychromatic)
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION: Because of the poor solubility of the test substance, 3 mg/kg was the highest dose possible to administer.


METHOD OF ANALYSIS: flow cytometer-based micronucleus assay; staining of the cells with Hoechst 33342 and thiazole orange


OTHER:

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

Treatment

Dose [mg/kg]

Frequency of PCE with MN

[‰] (mean ± SEM)

Frequency of PCE [%]

Control

0

1.00 ± 0.05

1.9 ± 0.4

Cr picolinate

0.75

0.95 ± 0.08

2.4 ± 0.4

1.5

0.94 ± 0.04

2.1 ± 0.3

3.0

1.08 ± 0.13

2.2 ± 0.3

Colchicine

1.0

3.78 ± 0.46

1.0 ± 0.4

Applicant's summary and conclusion