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EC number: 212-406-7 | CAS number: 814-80-2
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of clastogenicity of formic acid, acetic acid and lactic acid on cultured mamalian cells.
- Author:
- Morita, T., Takeda, K. and Okumura, K.
- Year:
- 1 990
- Bibliographic source:
- Mutation Research 240: 195-202
Materials and methods
- Principles of method if other than guideline:
- Preparation of metabolic activation system
S9 (Oriental Yeast Co., Ltd., Japan) was derived from the livers of rats pretreated with phenobarbital and 5,6-benzoflavone. The S9 activation system (S9 mix) was prepared just before use according to Matsuoka et al. (1979), and sterilized by filtration, except S9 fraction.
Chromosomal aberration test
Cells (2 x 104/dish) were cultured for 48 h before the test compounds were added. Each stock solution of formic acid, acetic acid or lactic acid was prepared in distilled water at 2 M and diluted appropriately with distilled water on the day of
use. An aliquot of 50-75 µl of diluted acid was added to the culture medium (5 ml). In the absence of S9 mix, chromosome preparations were made by an air-drying method 24 h after the addition of each organic acid. Cytotoxicity of each acid was also examined by counting surviving cells. In the presence of S9 mix, the cells were washed with physiological saline after a 6-h treatment, and then incubated with fresh medium for 18 h before the chromosome preparations were made (Ishidate, 1987).
In order to study the effect of neutralization of the treatment medium, 2 kinds of treatment media were examined; one was adjusted to pH 5.8 or pH 6.0 with each of these acids and the other was so adjusted then immediately neutralized to pH 6.4 and pH 7.2 with 1 M NaOH. In order to study the effect of enhancement of the buffering ability, chromosomal aberration tests were carried out on these acids in the absence of S9 mix using F12 medium containing 34 mM NaHCO) (twice the concentration usually employed). Furthermore, to study the effect of alteration of the buffering system, the tests were performed on these acids in the absence of S9 mix using F12 medium containing 30 mM HEPES instead of NaHC03 as a buffer. This medium was adjusted to pH 8.5 with NaOH, and the cells were incubated in closed culture vessels.
The pH of the medium was measured initially and at 6 hand 24 h after the treatment using a pH meter. 100 well-spread metaphases from 1 experiment were observed at each point to record the percentage (including gaps) of cells with chromosomal aberrations. At least 2 independent experiments were carried out in each case. - GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- L-(+)-lactic acid
- EC Number:
- 201-196-2
- EC Name:
- L-(+)-lactic acid
- Cas Number:
- 79-33-4
- IUPAC Name:
- 2-hydroxypropanoic acid
- Details on test material:
- D,L-Iactic acid (CH)CHOHCOOH, CAS No. 598-82-3, about 90% aqueous solution, pKa = 3.86) was purchased from Wako Pure Chemical Ind., Ltd. (Japan)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- The Chinese hamster ovary K1 cell line (CHOKl, Flow Laboratory, U.S.A.) was used. The cells were maintained in Ham's F12 medium (Flow) supplemented with 10% fetal calf serum, kanamycin (60 µg/ml) and 17 mM sodium bicarbonate (NaHC03). The cells were grown as monolayers at 370 C in a 5% CO2/95% air atmosphere. The cultures were regularly screened for mycoplasma contamination.
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate S9
- Test concentrations with justification for top dose:
- 8-35 mM
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 14-35 mM, when pH was <= 5.8
Any other information on results incl. tables
RS-Freetext:
When the culture medium was first acidified by the lactic
acid dose and neutralized to pH 6.4 or when medium is
containing 30 mM HEPES as buffer, lactic acid was
non-clastogenic.
Pseudo-positive reactions are seen as a result of
non-physiological low pH.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
other: results obtained need to be interpreted in the light of the medium pH
Using Chinese hamster ovary Kl cells, chromosomal aberration tests were carried out with formic acid, acetic acid and lactic acid, and the relationship between the pH of the medium and the clastogenic activity was examined. The medium used was Ham's F12 supplemented with 17 mM NaHC03 and 10% fetal calf serum. All of these acids induced chromosomal aberrations at the initial pH of ca. 6.0 or below (about 10-14 mM of each acid) both with and without S9 mix. Exposure of cells to about pH 5.7 or below (about 12-16 mM of each acid) was found to be toxic. When the culture medium was first acidified with each of these acids and then neutralized to pH 6.4 or pH 7.2 with NaOH, no clastogenio activity was observed. Using F12 medium supplemented with 34 mM NaHC03 as a buffer, no clastogenic activity was observed at doses up to 25 mM of these acids (initial pH 5.8-6.0). However, it was found that about 10% of the cells had aberrations at pH 5.7 or below (27.5-32.5 mM of each acid). Furthermore, when 30 mM HEPES was used as a buffer, chromosomal aberrations were not induced at doses up to 20 mM formic acid and acetic acid (initial pH 7.0-7.1), and at doses up to 30 mM lactic acid (initial pH 6.6). In the initial pH range of 6.4-6.7 (25-32.5 mM of each acid), chromosomal aberrations were observed. The above results show that these acids themselves are non-clastogenic, and the pseUdo-positive reactions attributable to non-physiological pH could be eliminated by either neutralization of the treatment medium or enhancement of the buffering ability. - Executive summary:
Using Chinese hamster ovary Kl cells, chromosomal aberration tests were carried out with formic acid, acetic acid and lactic acid, and the relationship between the pH of the medium and the clastogenic activity was examined. The medium used was Ham's F12 supplemented with 17 mM NaHC03 and 10% fetal calf serum. All of these acids induced chromosomal aberrations at the initial pH of ca. 6.0 or below (about 10-14 mM of each acid) both with and without S9 mix. Exposure of cells to about pH 5.7 or below (about 12-16 mM of each acid) was found to be toxic. When the culture medium was first acidified with each of these acids and then neutralized to pH 6.4 or pH 7.2 with NaOH, no clastogenio activity was observed. Using F12 medium supplemented with 34 mM NaHC03 as a buffer, no clastogenic activity was observed at doses up to 25 mM of these acids (initial pH 5.8-6.0). However, it was found that about 10% of the cells had aberrations at pH 5.7 or below (27.5-32.5 mM of each acid). Furthermore, when 30 mM HEPES was used as a buffer, chromosomal aberrations were not induced at doses up to 20 mM formic acid and acetic acid (initial pH 7.0-7.1), and at doses up to 30 mM lactic acid (initial pH 6.6). In the initial pH range of 6.4-6.7 (25-32.5 mM of each acid), chromosomal aberrations were observed. The above results show that these acids themselves are non-clastogenic, and the pseUdo-positive reactions attributable to non-physiological pH could be eliminated by either neutralization of the treatment medium or enhancement of the buffering ability.
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