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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
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: TThe published literature fulfilled basically scientific principles without GLP compliance statement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.21 (In Vitro Mammalian Cell Transformation Test)
GLP compliance:
no
Remarks:
old publication
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Reference substance name:
iodide in potassium
IUPAC Name:
iodide in potassium
Constituent 2
Reference substance name:
Potassium iodide
EC Number:
231-659-4
EC Name:
Potassium iodide
Cas Number:
7681-11-0
IUPAC Name:
potassium iodide
Details on test material:
Potassium iodide was purchased from J.T. Baker (Phillipsburg, N.J.).

Method

Species / strainopen allclose all
Species / strain / cell type:
mouse lymphoma L5178Y cells
Details on mammalian cell type (if applicable):
The l5178Y mouse-lymphoma cells were originally derived from a methylcholanthrene induced lymphoma (Fischer, 1958) and have subsequently been selected for heterozygous activity at the thymidine kinase locus (Give et al., 1972, 1973, 1975). The l5178Y cell line used in our studies was kindly supplied by Mr. Ken Palmer (Food and Drug Administration, Washington, D.C).
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
other: BALB/c 3T3
Details on mammalian cell type (if applicable):
Balb/c 3T3 cells (Dr. D. Brusick, litton Blonetics, Kensington, Md.), derived from done A31 of the Balb/c 3T3 1ine, were used for the transformation studies. The cells were grown in Eagle's Minimal Essential Medium with Eagle's- Salts (EMEM), supplemented with 10% fetal calf serum and 1 % 200 mM glutamine (Gibco). Stock cultures were maintained at 75% confluence. The maintenance medium was EMEM with 5% fetal calf serum.
Additional strain / cell type characteristics:
other:
Metabolic activation:
without
Metabolic activation system:
Iodide is small ion, so the metabolic actication system is unnecessary to the test
Test concentrations with justification for top dose:
Mutagenicity test:
100 μg/ml, 500 μg/ml, I mg/ml; 5 mg/ml, 10 mg/ml.

Transformation test:
100 μg/ml, 500 μg/ml, I mg/ml; 5 mg/ml, 10 mg/ml.
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
media
Negative solvent / vehicle controls:
no
Remarks:
no hazard vehicle used
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Remarks:
Migrated to IUCLID6: In report it was named EMS
Positive controls:
yes
Positive control substance:
N-dimethylnitrosamine
Remarks:
Migrated to IUCLID6: In report it was named DMN
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
Migrated to IUCLID6: In report it was named MNNG

Results and discussion

Test resultsopen allclose all
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: not applicable
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
other: BALB/c 3T3
Metabolic activation:
without
Genotoxicity:
other: not applicable
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
negative
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: no data
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1  Mutagenicity of iodide in the L5178Y Test System

Mutagenicity of iodide in the L5178Y Test System
Compound concentration .Mutational Frenquency
Iodide (KI solution) 10 mg/ml 1.0
5 mg/ml 0.76
1 mg/ml 1.33
500μg/ml 1.67
100 μg/ml 1.0
Negative control (Media)   1.0
EMS 500 μg/ml 12.0
MNNG 5 μg/ml 15.0

Table 2  Effects of iodide on the Transformation of Balb/c 313 Cells

Effects of iodide on the Transformation of Balb/c 313 Cells
Compound concentration .# of foci
iodide 10 mg/ml 0.33
5 mg/ml 2.0
1 mg/ml 0.61
500μg/ml 0.61
100 μg/ml 0.83
Negative control (Media)   1.22
MNNG 5 μg/ml 7.50

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative No effects can be found in either mutagenicity or BALB/c 3T3 cell transformation assays.

Solutions of potassium iodide at concentrations of 0.1–10 mg/ml did not cause mutagenic effects in L5178Y mouse lymphoma cells or transforming activity in Balb/c3T3 cells grown in culture.
Executive summary:

The mutagenic potential to iodide (in potassium iodide ) was studied using the L5178Y mouse (TK+/-) lymphoma assay. The established mutagens ethylmethanesulphonate (EMS) and dimethylnitrosamine (DMN) were highly active in this assay, whereas iodide (KI) was inactive. Using the BALB/c 3T3transformation assayweassessed the transformational capacities of these same agents and the positive mutagen N-ethyl-N-nitro-N-nitrosoguanidine(MNNG). All concentrations of the iodide tested were inactive in this assay. It can be concluded that KI did not possess any biologically significant mutagenic or cell transforming ability.