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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Remarks:
Only abstract and tables are available in English

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity studies of magnesium sulfate--reverse mutation test with bacteria and chromosomal aberration test with mammalian cells in culture
Author:
Yoshihiro Oguma,
Fumio Yokota,
Kaoru Inoue,
Kazunori Shimamura
Year:
1998
Bibliographic source:
The Journal of Toxicological Sciences, Vol. 23, Supplement I, 81-90, 1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test material

Constituent 1
Reference substance name:
Magnesium sulphate
EC Number:
231-298-2
EC Name:
Magnesium sulphate
Cas Number:
7487-88-9

Results and discussion

Applicant's summary and conclusion

Executive summary:

The mutagenicity potential of magnesium sulfate was re-assessed using the current procedure of the reverse mutation test with bacteria and chromosomal aberration test with mammalian cells (a Chinese hamster lung fibroblast cell line; CHL/IU) in culture. In the reverse mutation test with bacteria, Salmonella typhimurium TA100, TA98, TA1535 and TA1537 and Escherichia coli WP2 uvrA were use and the maximum dose level was set at 5000 micrograms/plate irrespective of the absence or presence of metabolic activation. Five dose levels (313-5000 micrograms/plate) were selected for all strains except for TA98 without metabolic activation and for TA1537 with metabolic activation, for which 6 dose levels (156-5000 micrograms/plate) were selected. Magnesium sulfate induced no increase in the number of colonies with reverse mutation in any of the strains irrespective of the absence of presence of metabolic activation in the dose-range-finding study or in the main study. In the chromosomal aberration test with mammalian cells, a Chinese hamster lung fibroblast cell line (CHL/IU) in culture was used and the maximum dose level was set at 5.0 mg/mL both in the direct and metabolic activation methods. Three dose levels (1.25-5.0 mg/mL) were selected. Magnesium sulfate induced no increase in the incidence of cells with chromosomal aberration or those with genome mutation (polyploidy) in any of the strains irrespective of the absence of presence of metabolic activation. Thus, it is concluded that magnesium sulfate does not have mutagenic potential under the presence experimental conditions.