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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
No detailed information on the number of concentrations tested, only maximum dose reported. No information on replicates.

Data source

Reference Type:
Primary Mutagenicity Screening of Food Additives Currently Used in Japan.
Ishidate M. Jr., T. Sofuni, K. Yoshikawa, M. Hayashi, T. Nohmi, M. Sawada, and A. Matsuoka.
Bibliographic source:
Food Chem. Toxicol. 22: 623-636.

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
, no metabolic activation used.
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium acetate
EC Number:
EC Name:
Sodium acetate
Cas Number:
Molecular formula:
sodium acetate
Details on test material:
- Test substance: sodium acetate, anhydrous
- Supplied by Japanese Food Additives Association where purity checked before use.


Species / strain
Species / strain / cell type:
mammalian cell line, other: Chinese hamster lung fibroblasts
Details on mammalian cell type (if applicable):
The cell line was originally established from the lung of a newborn female at the Cancer Research Institute, Tokyo (Koyama, Utakoji & Ono, 1970), and was maintained by 4-day passages in Minimum Essential Medium (MEM; GIBCO) supplemented by 10% calf serum. The modal chromosome number is 25 and the doubling time was approximately 15 hr.
Metabolic activation:
Test concentrations with justification for top dose:
up to 1.0 mg/ml
Vehicle / solvent:
Physiological saline
Untreated negative controls:
untreated cells and solvent treated cells in which the incidence of aberrations was usually less than 3.0%.
Negative solvent / vehicle controls:
True negative controls:
Positive controls:
A large number of substances were assayed in this study, including some
Positive control substance:
other: Test involved screening a large number of substances, some of which (eg hydrogen peroxide, sodium nitrite) gave positive results but no specific positive control as recommended in the guideline was used.
Details on test system and experimental conditions:
METHOD OF APPLICATION: Colcemid (final concen 0.2 ug(ml) was added to the culture 2 hr before cell harvesting, trypsinized and suspended in a hypotonic KCI solution (0.075 M) for 13 min at room temperature. The cells were centrifuged, fixed with acetic acid-methanol (I :3, v(v) and spread on clean glass slides, air-dried, and stained with Giemsa solution (1.5%, at pH 6.8; E. Merck) for 12-15 min.

- Exposure duration: 24 and 48 h

NUMBER OF CELLS EVALUATED: A hundred well-spread metaphases were observed under the microscope (x 600 with a nocover objective lens).

- Other: The incidence of polyploid cells as well as of cells with structural chromosomal aberrations such as chromatid or chromosome gaps, breaks, exchanges, ring formations, fragmentations and others, was recorded on each culture plate.

OTHER: The cells were exposed to each sample at three different doses
Evaluation criteria:
The results were considered to be negative if the incidence was less than 4.9%, equivocal if it was between 5.0 and 9.9%, and positive if it was more than 10.0%. Ethanol was used as the vehicle. For a quantitative evaluation of the clastogenic potential, the dose at which structural aberrations (including gaps) were detected in 20% of the metaphases was calculated (D20) along with the frequency of cells with exchange type aberrations per unit dose (mg/ml-TR value).  Low TR values indicate low carcinogenic potential in man. 

Results and discussion

Test results
Species / strain:
mammalian cell line, other: Chinese hamster lung fibroblasts
Metabolic activation:
Cytotoxicity / choice of top concentrations:
other: unclear from information available
Vehicle controls validity:
Untreated negative controls validity:
other: a number of other substances known to be non mutagenic gave positive results in this study.

Any other information on results incl. tables

The results were negative at 48 hours. 1% of metaphases were polyploid and none showed structural abberations.

Applicant's summary and conclusion

Interpretation of results (migrated information):
negative without metabolic activation
Executive summary:

Chromosome aberrations were studied in Chinese Hamster lung fibroblasts exposed to sodium acetate in physiological saline by Japan's National Institute of Hygeinic Sciences. No metabolic activation was used. No evidence of cytogenicity was seen.