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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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
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

Constituent 1
Reference substance name:
14639-25-9
Cas Number:
14639-25-9
IUPAC Name:
14639-25-9
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 or test system 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