Phosphoric acid, bis(phenylmethyl) ester, potassium salt (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Remarks:

1996-21-01

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

potassium dibenzyl phosphate

EC Number:

616-628-9

Cas Number:

78543-37-0

Molecular formula:

C14-H14-O4-P.K

IUPAC Name:

potassium dibenzyl phosphate

Test material form:

solid

Details on test material:

Batch 97/8

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Test concentrations with justification for top dose:

Dose: 0, 50, 150, 500, 1500, 5000 µg/plate
At 5000 µg/plate the test material caused no visible reduction in the growth of the bacterial lawn at any of the dose levels to anyof the strains of Salmonella tested.

Vehicle / solvent:

Distilled water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

mitomycin C

other: 2-Aminoanthracene, 1,8-dihydroxyanthroquinone

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation)

DURATION
- Preincubation period:
- Exposure duration: 48-hour incubation at 37°C

NUMBER OF REPLICATIONS:
Duplicate in the preliminary study
Triplicate in the main test

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

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

Test results 2

Species / strain:

S. typhimurium TA 1537

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

Test results 3

Species / strain:

S. typhimurium TA 98

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

Test results 4

Species / strain:

S. typhimurium 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

Test results 5

Species / strain:

S. typhimurium TA 102

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

Any other information on results incl. tables

Experiment 1 – Without metabolic activation

with or Without S9-mix	concentration µg/plate	Nimber of revertants (Number of colonies per plate)
		Base-pair Substitution tuype						Frameshift type
		TA100		TA1535		TA102		TA98		TA1537
-	0	66		12		219		21		7
			(67)		(15)		(220)		(19)		(9)
		73		14		226		24		13
			5.6		3.1		6.0		5.7		3.8
		62		18		214		13		6
-	50	76		16		224		14		5
			(72)		(16)		(224)		(15)		(11)
		70		20		218		17		16
			3.8		3.5		5.5		2.1		5.5
		69		13		229		13		11
-	150	65		11		20		15		7
			(71)		(14)		(223)		(18)		(11)
		75		18		220		16		12
			5.3		3.5		5.8		4.4		3.6
		73		14		230		23		14
-	500	61		18		229		15		8
			(66)		(18)		(226)		(18)		(11)
		68		15		215		20		11
			6.0		3.0		9.5		2.5		3.6
		68		21		233		18		11
-	1500	72		11		213		12		10
			(66)		(14)		(219)		(12)		(9)
		66		17		226		10		10
			6.0		3.0		6.5		2.0		1.7
		60		14		219		14		7
-	5000	65		15		218		17		10
			(66)		(16)		(225)		(16)		(7)
		71		20		235		18		4
			6.0		3.6		8.9		3.2		3.0
		63		13		222		12		7
Positive Controls S9-mix -	Name	ENNG		ENNG		MMC		4NQO		9AA
	Concentration (µg/plate	3		5		0.5		0.2		80
	N° colonies per plate	890		791		529		247		874
			(863)		(825)		(576)		(218)		(800)
		797		882		618		199		802
			57.1		49.9		25.5		25.5		75.0
		901		801		582		208		724

ENNG N-ethyl-N’-nitro-N-nitrosoguanidine

MMC Mitomycin C

4NQO 4-nitroquinoline-1-oxide

9AA 9-aminoacridine

 

Experiment 1 – With metabolic activation

with or Without S9-mix	concentration µg/plate	Nimber of revertants (Number of colonies per plate)
		Base-pair Substitution tuype						Frameshift type
		TA100		TA1535		TA102		TA98		TA1537
+	0	71		14		216		17		8
			’76)		(14)		(221)		(18)		(13)
		81		19		226		24		17
			5.0		4.5		5.0		5.1		4.7
		76		10		222		14		15
+	50	77		13		224		14		9
			(74)		(13)		(226)		(16)		(12)
		82		16		236		15		11
			9.8		3.0		9.6		2.1		4.2
		63		10		217		18		17
+	150	68		12		224		11		10
			(75)		(14)		(217)		(12)		(12)
		77		17		217		10		16
			5.9		1.5		6.5		3.2		3.8
		81		10		211		16		9
+	500	68		14		213		12		9
			(76)		(15)		(219)		(18)		(12)
		79		15		228		22		12
			2.3		2.9		7.9		5.1		2.5
		70		2		216		19		14
+	1500	75		13		214		17		14
			(75)		(13)		(221)		(16)		(14)
		79		81		228		15		17
			10.4		4.2		7.0		1.0		3.0
		75		13		220		16		11
+	5000	63		12		214		20		7
							(220)		(19)		(11)
		82		10		219		21		11
							6.6		3.2		3.5
		80		18		227		15		14
Positive Controls S9-mix -	Name	2AA		2AA		DANTHRON		2AA		2AA
	Concentration (µg/plate	1		2		10		0.5		2
	N° colonies per plate	1045		325		510		386		321
			(1046)		(302)		(543)		(312)		(329)
		1121		288		503		259		350
			74.0		19.9		62.7		65.9		18.7
		973		294		615		292		315

2AA: 2-aminoanthracene

DANTHRON: 1.8-dihydroxyanthraquinone

 

 

Experiment 2 – Without metabolic activation

with or Without S9-mix	concentration µg/plate	Nimber of revertants (Number of colonies per plate)
		Base-pair Substitution tuype						Frameshift type
		TA100		TA1535		TA102		TA98		TA1537
-	0	101		26		271		17		11
			(99)		(22)		(270)		(20)		(8)
		96		21		277		20		6
			2.9		3.6		7.0		3.0		2.5
		101		19		263		23		8
-	50	91		21		264		20		5
			(93)		(25)		(274)		(18)		(8)
		78		29		270		16		9
			16.6		4.0		12.5		2.0		2.3
		111		26		288		18		9
-	150	73		20		218		20		11
			(81)		(22)		(232)		(19)		(9)
		93		29		262		19		7
			10.6		6.2		25.7		1.0		2.1
		77		17		217		18		8
-	500	92		23		228		18		10
			(94)		(21)		(233)		(19)		(10)
		99		18		254		23		14
			4.7		2.9		19.4		3.6		3.5
		90		23		216		16		7
-	1500	109		25		264		22		15
			(101)		(24)		(271)		(21)		(11)
		91		25		286		19		11
			9.2		2.9		13.3		2.1		3.5
		103		23		262		23		8
-	5000	105		24		287		18		9
			(89)		(24)		(255)		(17)		(10)
		74		24		244		12		9
			15.5		0.6		28.5		4.2		1.2
		89		25		233		20		11
Positive Controls S9-mix -	Name	ENNG		ENNG		MMC		4NQO		9AA
	Concentration (µg/plate	3		5		0.5		0.2		80
	N° colonies per plate	1083		1088		595		213		742
			(1017)		(1052)		(588)		(228)		(785)
		922		1115		544		197		708
			84.3		86.8		41.0		41.2		105.9
		1046		953		625		275		906

ENNG N-ethyl-N’-nitro-N-nitrosoguanidine

MMC Mitomycin C

4NQO 4-nitroquinoline-1-oxide

9AA 9-aminoacridine

 

  

Experiment 2 – With metabolic activation

with or Without S9-mix	concentration µg/plate	Nimber of revertants (Number of colonies per plate)
		Base-pair Substitution tuype						Frameshift type
		TA100		TA1535		TA102		TA98		TA1537
+	0	103		14		272		28		10
			(108)		(13)		(276)		(27)		(10)
		101		15		279		30		8
			9.9		2.1		3.5		3.6		2.5
		119		11		276		23		13
+	50	117		17		284		31		7
			(114)		(18)		(273)		(29)		(8)
		103		23		256		29		11
			9.8		5.0		14.7		2.0		2.3
		122		13		278		27		7
+	150	120		10		272		29		15
			(118)		(13)		(253)		(32)		(12)
		112		16		249		29		11
			4.9		3.0		17.3		4.6		3.1
		121		13		238		37		9
+	500	117		25		275		24		10
			(113)		(18)		(274)		(22)		(10)
		113		16		281		25		8
			4.0		6.2		8.1		4.9		2.5
		109		13		265		16		13
+	1500	113		15		291		19		8
			(121)		(14)		(282)		(23)		(8)
		129		16		282		25		8
			8.0		2.1		9.5		3.8		0.0
		120		12		272		26		8
+	5000	111		15		280		25		13
			(112)		(14)		(278)		(27)		(10)
		128		10		271		26		8
			15.5		3.2		6.2		2.6		2.5
		97		16		283		30		10
Positive Controls S9-mix -	Name	2AA		2AA		DANTHRON		2AA		2AA
	Concentration (µg/plate	1		2		10		0.5		2
	N° colonies per plate	1060		347		523		483		171
			(1038)		(329)		(556)		(471)		(197)
		1135		315		622		506		216
			109.7		16.5		56.9		42.3		23.2
		919		324		524		424		203

2AA: 2-aminoanthracene

DANTHRON: 1.8-dihydroxyanthraquinone

 

Applicant's summary and conclusion

Conclusions:

The Dibenzyl Potassium Phosphate was considered to be not genotoxic in an Ames test.

Executive summary:

The genotoxicty od Dibenzyl Potassium Phosphate has been determined according to OECD 471 test guideline ijn compliance with GLP

In this test, the substance was determinated to be non- genotoxic.