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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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well performed, well described study, commissioned in 1979 by USFDA and performed by reputed laboratory. Raw data available and method essentially as described in EU test method B13/14. Lack of evidence of GLP is only reason for not asigning Klimisch 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
yes
Remarks:
Duplicate instead of triplicate plates. However tests were performed twice.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium sodium tartrate
EC Number:
206-156-8
EC Name:
Potassium sodium tartrate
Cas Number:
304-59-6
Molecular formula:
C4H6O6.K.Na
IUPAC Name:
potassium sodium tartrate
Details on test material:
F76-019 - Potassium sodium tartrate. Mallinckrodt Lot #WBPS
Purity not stated but assumed analytical grade (i.e. ca. 99%)

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Arochlor-1254 stimulated rat-liver homogenate (S9 mix) according to Ames et al.
Test concentrations with justification for top dose:
A range-finding assay was performes on strain TA 100 at concentrations of 0.3 - 10.000 µg/plate.
Sunsequently two assays were performed using the following test concentrations: 0.3, 3.3, 33.3, 100.0, 333.3, 1000.0, 3333.3 and 10000 µg/plate. In the second assay only the 6 highest concentrations were used.
Vehicle / solvent:
0.067 Potassium Phosphate buffer is used as vehicle / solvent (ph 7.0).
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-anthramine
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
Details on test system and experimental conditions:
Test performed according to test developed by B. Ames. Briefly, innoculum from stck cultures is grown overnight a 37°C in Oxoid nutrient broth. After stationary overnight growth cultures are shaken for 3 - 4 h for optimal exponential growth.The standard plata-incorporation method is employed and test substance and controls are plated, with and without metabolic activation. Plates are incubated for 48 h at 37 °C and revertants are counted and recorded. Metabolic activation mixture contains 10% S9 fraction.
Evaluation criteria:
Not recordad, as no positive response was found. Presumably the modified two-fold rule is employed as stated in source publications and reference test method.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Report states that in the second experiment performed abnormally high numver of revertabts were seen with strains TA 1535 and TA100 (in samples and negative controls). This was subsequently attributed to the presence of traces of ethylene oxide in the plates used.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

TABLE 1. SALMONELLA TYPHIMURIUM STRAIN TA1535. FDA COMPOUND F76-019 (Potassium Sodium Tartrate)

Compound  Metabolic  Micrograms of compound  Histidine revertants per plate  
  Activation added per plate   Experiment 1*     Experiment 2*  
        14 March 1978     7 July 1978  
          Average     Average
Negative control   31 36 41 19 14 15
    37 60   14 14  
  +   48 35 41 4 4 5
  +   37 45   7 4  
Positive controls                
Sodium azide 0,5 264     344 256 300
2-Anthramine 1 37     7    
  + 1 119     76    
F76-019 0,3       14 13 14
  3,3       15 18 17
  33,3 30 67 49 13 14 14
  100 44 41 43 13 9 11
  333,3 37 39 38 13 14 14
  1000 51 45 48 14 7 11
  3333,3 42 52 47 15 17 16
  10000 24 50 37 16 8 12
  + 0,3       9 9 9
  + 3,3       8 6 7
  + 33,3 54 84 69 4 9 7
  + 100 43 113 78 5 6 6
  + 333,3 63 70 67 7 4 6
  + 1000 54 63 59 4 5 5
  + 3333,3 56 67 62 4 8 6
  + 10000 51 53 52 11 2 7
                 

TABLE 2. SALMONELLA TYPHIMURIUM STRAIN TA1537. FDA COMPOUND F76-019 (Potassium Sodium Tartrate)
Compound  Metabolic  Micrograms of compound                                                   Histidine revertants per plate  
  Activation added per plate   Experiment 1     Experiment 2  
        28 February 1978     14 March 1978  
          Average     Average
Negative control   17 24 16 6 3 5
    9 14   4 5  
  +   12 5 11 11 3 7
  +   15 13   10 4  
Positive controls                
9-Aminoacridine 50 150 219 185 154    
2-Anthramine 1 NT     3    
  + 1 NT     41    
F76-019 0,3 12 13 13      
  3,3 10 19 15      
  33,3 15 20 18 5 4 5
  100 17 7 12 6 2 4
  333,3 13 15 14 5 5 5
  1000 9 12 11 1 8 5
  3333,3 14 23 19 1 5 3
  10000 18 9 14 5 4 5
  + 0,3 14 14 14      
  + 3,3 16 19 18      
  + 33,3 15 16 16 6 12 9
  + 100 18 18 18 8 9 9
  + 333,3 17 10 14 7 8 8
  + 1000 13 11 12 11 4 8
  + 3333,3 14 12 13 6 3 5
  + 10000 13 24 19 8 4 6

TABLE 3. SALMONELLA TYPHIMURIUM STRAIN TA1538. FDA COMPOUND F76-019 (Potassium Sodium Tartrate)
Compound  Metabolic  Micrograms of compound                                                   Histidine revertants per plate  
  Activation added per plate   Experiment 1     Experiment 2  
        28 February 1978     14 March 1978  
          Average     Average
Negative control   13 13 13 9 14 11
    12 13   9 10  
  +   21 16 22 24 19 21
  +   28 23   18 21  
Positive controls                
2-Nitrofluorene 5 597 787 692 591    
2-Anthramine 1 NT     19    
  + 1 NT     89    
F76-019 0,3 13 17 15      
  3,3 14 11 13      
  33,3 21 17 19 20 8 14
  100 5 14 10 14 4 9
  333,3 29 21 25 19 17 18
  1000 14 8 11 15 7 11
  3333,3 18 10 14 14 16 15
  10000 13 19 16 20 14 17
  + 0,3 9 32 21      
  + 3,3 14 19 17      
  + 33,3 26 37 32 29 23 26
  + 100 30 34 32 27 22 25
  + 333,3 31 23 27 28 21 25
  + 1000 29 20 25 25 22 24
  + 3333,3 21 27 24 25 25 25
  + 10000 44 24 34 27 15 21

TABLE 4. SALMONELLA TYPHIMURIUM STRAIN TA98. FDA COMPOUND F76-019 (Potassium Sodium Tartrate)
Compound  Metabolic  Micrograms of compound                                                   Histidine revertants per plate  
  Activation added per plate   Experiment 1     Experiment 2  
        28 February 1978     14 March 1978  
          Average     Average
Negative control   28 21 24 19 18 15
    20 27   11 12  
  +   37 38 36 18 37 27
  +   41 29   27 27  
Positive controls                
2-Nitrofluorene 5 345 373 359 359    
2-Anthramine 2,5 39     18    
  + 2,5 965     104    
F76-019 0,3 26 17 22      
  3,3 25 21 23      
  33,3 23 19 21 31 11 21
  100 25 22 24 19 21 20
  333,3 26 18 22 15 17 16
  1000 20 23 22 15 27 21
  3333,3 22 33 28 19 14 17
  10000 12 15 14 17 13 15
  + 0,3 51 42 47      
  + 3,3 30 37 34      
  + 33,3 32 48 40 39 48 44
  + 100 27 35 31 36 35 36
  + 333,3 37 38 38 18 36 27
  + 1000 42 47 45 18 37 28
  + 3333,3 38 30 34 21 36 29
  + 10000 32 37 35 29 24 27

TABLE 6. ESCHERICHIA COLI WP2. FDA COMPOUND F76-019 (Potassium Sodium Tartrate)
Compound  Metabolic  Micrograms of compound                                                   Tryptophan Revertants per plate  
  Activation added per plate   Experiment 1     Experiment 2  
        28 February 1978     14 March 1978  
          Average     Average
Negative control   65 45 50 33 36 33
    60 31   31 30  
  +   55 53 57 57 45 40
  +   65 56   24 34  
Positive controls                
AF2 0,1 104 102 103 1581    
2-Anthramine 10 72     NT*    
  + 10 166          
F76-019 0,3 43 54 49      
  3,3 53 48 51      
  33,3 39 55 47 42 28 35
  100 45 37 41 32 39 36
  333,3 51 39 45 39 43 41
  1000 42 30 36 39 29 34
  3333,3 44 52 48 23 48 36
  10000 57 48 53 29 49 39
  + 0,3 57 37 47      
  + 3,3 52 53 53      
  + 33,3 48 48 48 43 44 44
  + 100 53 48 51 50 66 58
  + 333,3 53 50 52 50 36 43
  + 1000 63 55 59 46 57 52
  + 3333,3 48 50 49 50 48 49
  + 10000 52 56 54 53 60 57

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Potassium sodium tartrate tested in the Ames test with and without metabolic activation on Salmonella strains TA 1535, TA 1537, TA98, TA 100 and E.coli strain WP2 did not reveal any significant increase in revertants attributable to the test concentrations tested, neither signs of toxicity (as seen by background lawn observation) up to a maximum concentration of 10 mg/plate. Thereby the sample is considered to be negative in the bacterial mutagenicity test performed.
Executive summary:

Potassium sodium tartrate tested in the Ames test with and without metabolic activation on Salmonella strains TA 1535, TA 1537, TA98, TA 100 and E.coli strain WP2 did not reveal any significant increase in revertants attributable to the test concentrations tested, neither signs of toxicity (as seen by background lawn observation) up to a maximum concentration of 10 mg/plate. Thereby the sample is considered to be negative in the bacterial mutagenicity test performed.