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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation in vitro:

Ames test:

Ames assay was performed to investigate the potential of Potassium hydrogen phthalate (CAS No. 877-24-7) to induce gene muta­tions in comparison to negative control according to the plate incorporation test (Trial I) and the pre-incubation test (Trial II) using theSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100 and TA 102.

The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the negative and positive controls was tested in triplicate. Based on the solubility and precipitation test results eight different concentrations viz., 0.0 (N.C), 0.002, 0.005, 0.016, 0.050, 0.158, 0.501, 1.582 and 5 mg/plate were selected for pre-experiment.

Based on the pre-experiment results, the test item was tested with the following concentrations: 0 (NC), 0.050, 0.158, 0.501, 1.582 and 5 mg/plate for main study, both in the presence of metabolic activation (+S9) and in the absence of metabolic activation (-S9).

No substantial increase in revertant colony numbers in any of the tester strains were observed following treatment with Potassium hydrogen phthalate (CAS No. 877-24-7) at any dose level in both the confirmatory trials, neither in the presence nor in the absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. The spontaneous reversion rates in the negative and positive controls were within the range of our historical data.

The positive controls used for various strains showed a distinct in­crease in induced revertant colonies in both the methods i.e. Plate incorporation method and Pre-incubation method.

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item [Potassium hydrogen phthalate (CAS No. 877-24-7)] did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19-02-2018 - 06-04-2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from study report
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
This study was performed to investigate the potential of Potassium hydrogen phthalate (CAS No. 877-24-7) to induce gene muta¬tions in comparison to negative control according to the plate incorporation test (Trial I) and the pre-incubation test (Trial II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
Histidine
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
other:
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced S9 metabolic activation system
Test concentrations with justification for top dose:
0 (NC), 0.050, 0.158, 0.501, 1.582 and 5 mg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: RO (Reverse Osmosis) Water
- Justification for choice of solvent/vehicle: The test chemical was soluble in RO (Reverse Osmosis) Water
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
RO (Reverse Osmosis) Water
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
methylmethanesulfonate
other: 4-Nitro-o-phenylenediamine (TA 1537, TA 98, without S9); 2-Aminoanthracene (TA 1535, TA 1537, TA 98, TA 100 and TA 102, with S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation- Trial I); preincubation (Trial II)

DURATION
- Preincubation period: Trial I: Not applicable Trial II: 60 min
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data

SPINDLE INHIBITOR (cytogenetic assays): No data

STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: Each concentration, including the negative, vehicle and positive controls was tested in triplicate in two independent experiments performed

METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Not applicable

NUMBER OF CELLS EVALUATED: No data

NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data

CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
- Any supplementary information relevant to cytotoxicity: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data

- OTHER: No data
Rationale for test conditions:
No data
Evaluation criteria:
A test item is considered as a mutagen, if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100 and TA 102) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed..

A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.

An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.

A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative control and vehicle control such an increase is not considered biologically relevant.
Statistics:
No data
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Definition of acceptable cells for analysis: No data
- Other confounding effects: No data

RANGE-FINDING/SCREENING STUDIES: To evaluate the toxicity of the test item, a pre-experiment was performed with strains TA 98 and TA 100. Eight concentrations ([0.0 (N.C), 0.002, 0.005, 0.016, 0.050, 0.158, 0.501, 1.582 and 5 mg/plate) ] were tested for toxicity and mutation induction with 3 plates each (triplicates). The experimental conditions in this pre-experiment were the same as described below for the Trial-I (Plate incorporation test). Toxicity of the test item results in a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn.

In the pre-experiment, the concentration range of the test item was 0.002 - 5 mg/plate based on the solubility and precipitation test. In treated concentrations 5 - 0.002 mg/plate (T8-T1) no colony reduction or back ground lawn reduction was observed both, in absence and in the presence of metabolic activation. Based on the results of pre-experiment following doses were selected for the main study trials: 0.0 (N.C), 0.050, 0.158, 0.501, 1.582 and 5 mg/plate, both in the absence (-S9) as well as in the presence of metabolic activation (+S9).

CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: No data

NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: No data
- Indication whether binucleate or mononucleate where appropriate: No data

HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: No data
- Negative (solvent/vehicle) historical control data: No data

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: No data
- Other observations when applicable: No data
Remarks on result:
other: No mutagenic potential

TABLE1- REVERTANT COUNT FOR PRE-EXPERIMENT

Dose (mg/plate)

R

Without metabolic activation (-S9)

With metabolic activation (+S9)

TA100

TA 98

TA100

TA 98

NC

(0.00)

R1

88

17

91

17

R2

90

20

96

18

R3

85

20

90

18

T1

(0.002)

R1

87

17

102

21

R2

91

18

100

22

R3

88

20

94

18

T2

(0.005)

R1

83

18

83

19

R2

94

21

90

15

R3

97

21

90

19

T3

(0.016)

R1

91

19

92

20

R2

93

16

88

23

R3

88

18

84

22

T4

(0.050)

R1

92

22

89

18

R2

90

22

93

22

R3

86

20

91

22

T5

(0.158)

R1

93

24

98

17

R2

91

21

95

20

R3

96

20

93

21

T6

(0.501)

R1

99

21

96

17

R2

94

18

94

16

R3

104

18

88

19

T7

(1.582)

R1

91

23

84

21

R2

86

17

96

18

R3

88

19

94

20

T8

(5)

R1

67

15

75

13

R2

58

14

78

11

R3

71

11

76

11

PC

R1

1088

786

1668

828

R2

1133

794

1792

1033

R3

1129

849

1819

1114

NC           =     Negative control

PC            =     Positive control             

R              =     Replicate

T              =     Test concentration (T8: Highest, T1: Lowest)

4-Nitro-o-phenylenediamine [10μg/plate]: TA 98

Sodium azide [10μg/plate]: TA 100,

2-Aminoanthracene [2.5μg/plate]: TA98, TA100

 

TABLE 2 - REVERTANT COUNT IN PLATE INCORPORATION METHOD (TRIAL I)

Dose (mg/plate)

R

In the presence of Metabolic Activation (+S9)

TA 1537

TA 1535

TA 98

TA 100

TA 102

NC

(0.00)

R1

6

11

17

91

300

R2

4

15

18

96

299

R3

10

12

18

90

287

T1

(0.050)

R1

7

11

18

89

296

R2

4

10

22

93

275

R3

6

14

22

91

300

T2

(0.158)

R1

8

12

17

98

283

R2

5

11

20

95

293

R3

6

13

21

93

296

T3

(0.501)

R1

7

12

17

96

275

R2

7

14

16

94

287

R3

4

10

19

88

280

T4

(1.582)

R1

8

13

21

84

261

R2

8

13

18

96

275

R3

4

9

20

94

291

T5

(5)

R1

6

12

13

75

300

R2

8

14

11

78

292

R3

9

10

11

76

286

PC

R1

215

455

828

1668

1983

R2

225

405

1033

1792

1671

R3

198

568

1114

1819

1834

 

Dose (mg/plate)

R

In the Absence of Metabolic Activation (-S9)

TA 1537

TA 1535

TA 98

TA 100

TA 102

NC

(0.00)

R1

8

13

17

88

289

R2

10

11

20

90

276

R3

7

9

20

85

298

T1

(0.050)

R1

6

10

22

92

301

R2

9

12

22

90

255

R3

7

10

20

86

286

T2

(0.158)

R1

6

9

24

93

281

R2

8

8

21

91

273

R3

9

13

20

96

291

T3

(0.501)

R1

5

11

21

99

256

R2

4

11

18

94

263

R3

9

9

18

104

279

T4

(1.582)

R1

4

14

23

91

266

R2

5

10

17

86

298

R3

10

8

19

88

274

T5

(5)

R1

10

11

15

67

245

R2

4

9

14

58

280

R3

6

12

11

71

274

PC

R1

175

1413

786

1088

1565

R2

183

1375

794

1133

1681

R3

203

1441

849

1129

1496

NC= Negative Control,T =Test concentration (T5: Highest, T1: Lowest),R= Replicate

PC= Positive control                                                                       2-Aminoanthracene [2.5μg/plate]: TA 1537, TA1535, TA 98, TA 100        
2- Aminoanthracene [10μg/plate]:TA 102                                             Sodium azide [10μg/plate]: TA 1535, TA 100                                             

4-Nitro-o-phenylenediamine: TA 1537[50μg/plate], TA 98[10μg/plate]      Methyl methanesulfonate [4μl/plate]: TA 102

 

TABLE 3 - REVERTANT COUNT IN PRE-INCUBATION METHOD (TRIAL II)

Dose (mg/plate)

R

In the presence of Metabolic Activation (+S9)

TA 1537

TA 1535

TA 98

TA 100

TA 102

NC

(0.00)

R1

10

16

20

79

281

R2

6

12

18

115

289

R3

4

15

18

97

300

T1

(0.050)

R1

4

15

21

97

295

R2

7

15

16

93

291

R3

5

11

18

100

283

T2

(0.158)

R1

8

12

17

80

280

R2

4

15

17

91

255

R3

7

14

14

80

300

T3

(0.501)

R1

9

16

16

86

281

R2

8

16

17

97

285

R3

5

10

20

97

290

T4

(1.582)

R1

5

17

21

101

295

R2

6

18

23

92

298

R3

8

10

19

98

300

T5

(5)

R1

7

16

20

83

263

R2

8

17

17

91

275

R3

6

17

16

98

280

PC

R1

215

150

1123

1788

1783

R2

205

163

1046

1810

1891

R3

198

142

987

1793

1903

 

Dose (mg/plate)

R

In the Absence of Metabolic Activation (-S9)

TA 1537

TA 1535

TA 98

TA 100

TA 102

NC

(0.00)

R1

9

17

18

101

291

R2

7

13

19

95

255

R3

8

12

23

89

260

T1

(0.050)

R1

5

10

20

86

272

R2

9

15

19

100

245

R3

7

17

15

100

250

T2

(0.158)

R1

6

16

16

115

260

R2

9

11

17

106

269

R3

4

14

21

94

280

T3

(0.501)

R1

10

13

22

95

289

R2

4

11

16

95

281

R3

6

15

15

89

300

T4

(1.582)

R1

6

16

18

86

255

R2

7

10

20

80

262

R3

9

17

20

101

269

T5

(5)

R1

6

14

21

98

270

R2

5

12

16

100

279

R3

10

11

14

98

283

PC

R1

155

1563

893

1291

1904

R2

180

1321

745

1138

1880

R3

173

1481

901

1197

2032

NC= Negative Control,T =Test concentration (T5: Highest, T1: Lowest),R= Replicate

PC= Positive control                                                                       2-Aminoanthracene [2.5μg/plate]: TA 1537, TA1535, TA98, TA100        
2-Aminoanthracene [10μg/plate]:TA 102                                              Sodium azide [10μg/plate]: TA 1535, TA 100,                                            

4-Nitro-o-phenylenediamine: TA 1537[50μg/plate] TA 98[10μg/plate]        Methyl methanesulfonate [4μl/plate]: TA 102

TABLE 4 - MEAN REVERTANT COUNT IN PLATE INCORPORATION METHOD (TRIALI)

Dose (mg/plate)

In the presence of Metabolic Activation (+S9)

TA 1537

TA 1535

TA 98

TA 100

TA 102

MEAN

SD

MEAN

SD

MEAN

SD

MEAN

SD

MEAN

SD

NC

(0.00)

6.67

3.06

12.67

2.08

17.67

0.58

92.33

3.21

295.33

7.23

T1

(0.050)

5.67

1.53

11.67

2.08

20.67

2.31

91.00

2.00

290.33

13.43

T2

(0.158)

6.33

1.53

12.00

1.00

19.33

2.08

95.33

2.52

290.67

6.81

T3

(0.501)

6.00

1.73

12.00

2.00

17.33

1.53

92.67

4.16

280.67

6.03

T4

(1.582)

6.67

2.31

11.67

2.31

19.67

1.53

91.33

6.43

275.67

15.01

T5

(5)

7.67

1.53

12.00

2.00

11.67

1.15

76.33

1.53

292.67

7.02

PC

212.67

13.65

476.00

83.50

991.67

147.41

1759.67

80.53

1829.33

156.05

 

 

 

Dose

(mg/plate)

In the Absence of Metabolic Activation (-S9)

TA 1537

TA 1535

TA 98

TA 100

TA 102

MEAN

SD

MEAN

SD

MEAN

SD

MEAN

SD

MEAN

SD

NC

(0.00)

8.33

1.53

11.00

2.00

19.00

1.73

87.67

2.52

287.67

11.06

T1

(0.050)

7.33

1.53

10.67

1.15

21.33

1.15

89.33

3.06

280.67

23.46

T2

(0.158)

7.67

1.53

10.00

2.65

21.67

2.08

93.33

2.52

281.67

9.02

T3

(0.501)

6.00

2.65

10.33

1.15

19.00

1.73

99.00

5.00

266.00

11.79

T4

(1.582)

6.33

3.21

10.67

3.06

19.67

3.06

88.33

2.52

279.33

16.65

T5

(5)

6.67

3.06

10.67

1.53

13.33

2.08

65.33

6.66

266.33

18.72

PC

187.00

14.42

1409.67

33.13

809.67

34.30

1116.67

24.91

1580.67

93.49

NC= Negative Control,T =Test concentration (T5: Highest, T1: Lowest),SD= Standard Deviation

PC= Positive control

2-Aminoanthracene [2.5μg/plate]: TA 1537, TA 1535, TA 98, TA 100                  Methyl methanesulfonate [4μl/plate]: TA 102

2-Aminoanthracene [10μg/plate]:TA 102                                           

Sodium azide [10μg/plate]: TA 1535, TA 100

4-Nitro-o-phenylenediamine: TA 1537[50μg/plate], TA 98 [10μg/plate]

 

 

 

 

TABLE 5 - MEAN REVERTANT COUNT IN PRE-INCUBATIONMETHOD (TRIAL II)

Dose

(mg/plate)

In the presence of Metabolic Activation (+S9)

TA 1537

TA 1535

TA 98

TA 100

TA 102

MEAN

SD

MEAN

SD

MEAN

SD

MEAN

SD

MEAN

SD

NC

(0.00)

6.67

3.06

14.33

2.08

18.67

1.15

97.00

18.00

290.00

9.54

T1

(0.050)

5.33

1.53

13.67

2.31

18.33

2.52

96.67

3.51

289.67

6.11

T2

(0.158)

6.33

2.08

13.67

1.53

16.00

1.73

83.67

6.35

278.33

22.55

T3

(0.501)

7.33

2.08

14.00

3.46

17.67

2.08

93.33

6.35

285.33

4.51

T4

(1.582)

6.33

1.53

15.00

4.36

21.00

2.00

97.00

4.58

297.67

2.52

T5

(5)

7.00

1.00

16.67

0.58

17.67

2.08

90.67

7.51

272.67

8.74

PC

206.00

8.54

151.67

10.60

1052.00

68.20

1797.00

11.53

1859.00

66.09

 

 

 

Dose

(mg/plate)

In the Absence of Metabolic Activation (-S9)

TA 1537

TA 1535

TA 98

TA 100

TA 102

MEAN

SD

MEAN

SD

MEAN

SD

MEAN

SD

MEAN

SD

NC

(0.00)

8.00

1.00

14.00

2.65

20.00

2.65

95.00

6.00

268.67

19.50

T1

(0.050)

7.00

2.00

14.00

3.61

18.00

2.65

95.33

8.08

255.67

14.36

T2

(0.158)

6.33

2.52

13.67

2.52

18.00

2.65

105.00

10.54

269.67

10.02

T3

(0.501)

6.67

3.06

13.00

2.00

17.67

3.79

93.00

3.46

290.00

9.54

T4

(1.582)

7.33

1.53

14.33

3.79

19.33

1.15

89.00

10.82

262.00

7.00

T5

(5)

7.00

2.65

12.33

1.53

17.00

3.61

98.67

1.15

277.33

6.66

PC

169.33

12.90

1455.00

123.08

846.33

87.85

1208.67

77.16

1938.67

81.71

NC= Negative Control,T =Test concentration (T5: Highest, T1: Lowest),SD= Standard Deviation

PC= Positive control

2-Aminoanthracene [2.5μg/plate]: TA 1537, TA 1535, TA 98, TA 100                  Methyl methanesulfonate [4μl/plate]: TA 102

2-Aminoanthracene [10μg/plate]:TA 102                                           

Sodium azide [10μg/plate]: TA 1535, TA 100

4-Nitro-o-phenylenediamine: TA 1537[50μg/plate], TA 98 [10μg/plate]

Conclusions:
Potassium hydrogen phthalate (CAS No. 877-24-7) did not induce gene mutations by base pair changes or frame shifts in the genome of the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
Executive summary:

Ames assay was performed to investigate the potential of Potassium hydrogen phthalate (CAS No. 877-24-7) to induce gene muta­tions in comparison to negative control according to the plate incorporation test (Trial I) and the pre-incubation test (Trial II) using theSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100 and TA 102.

The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the negative and positive controls was tested in triplicate. Based on the solubility and precipitation test results eight different concentrations viz., 0.0 (N.C), 0.002, 0.005, 0.016, 0.050, 0.158, 0.501, 1.582 and 5 mg/plate were selected for pre-experiment.

Based on the pre-experiment results, the test item was tested with the following concentrations: 0 (NC), 0.050, 0.158, 0.501, 1.582 and 5 mg/plate for main study, both in the presence of metabolic activation (+S9) and in the absence of metabolic activation (-S9).

No substantial increase in revertant colony numbers in any of the tester strains were observed following treatment with Potassium hydrogen phthalate (CAS No. 877-24-7) at any dose level in both the confirmatory trials, neither in the presence nor in the absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. The spontaneous reversion rates in the negative and positive controls were within the range of our historical data.

The positive controls used for various strains showed a distinct in­crease in induced revertant colonies in both the methods i.e. Plate incorporation method and Pre-incubation method.

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item [Potassium hydrogen phthalate (CAS No. 877-24-7)] did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene mutation in vitro:

Ames test:

Ames assay was performed to investigate the potential of Potassium hydrogen phthalate (CAS No. 877-24-7) to induce gene muta­tions in comparison to negative control according to the plate incorporation test (Trial I) and the pre-incubation test (Trial II) using theSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100 and TA 102.

The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the negative and positive controls was tested in triplicate. Based on the solubility and precipitation test results eight different concentrations viz., 0.0 (N.C), 0.002, 0.005, 0.016, 0.050, 0.158, 0.501, 1.582 and 5 mg/plate were selected for pre-experiment.

Based on the pre-experiment results, the test item was tested with the following concentrations: 0 (NC), 0.050, 0.158, 0.501, 1.582 and 5 mg/plate for main study, both in the presence of metabolic activation (+S9) and in the absence of metabolic activation (-S9).

No substantial increase in revertant colony numbers in any of the tester strains were observed following treatment with Potassium hydrogen phthalate (CAS No. 877-24-7) at any dose level in both the confirmatory trials, neither in the presence nor in the absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. The spontaneous reversion rates in the negative and positive controls were within the range of our historical data.

The positive controls used for various strains showed a distinct in­crease in induced revertant colonies in both the methods i.e. Plate incorporation method and Pre-incubation method.

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item [Potassium hydrogen phthalate (CAS No. 877-24-7)] did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used.

Based on the experimental data available for the test chemical, Potassium hydrogen phthalate (CAS No. 877-24-7) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the experimental data available for the test chemical, Potassium hydrogen phthalate (CAS No. 877-24-7) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.

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