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REACH

Benzotriazole-1-yl-oxy-tris-pyrrolidino-phosphonium hexafluorophosphate

EC number: 603-290-2 | CAS number: 128625-52-5

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In a bacterial reverse mutation test (plate incorporation test) according to OECD TG 471 the test item was not mutagenic in the absence and presence of a rat liver metabolizing system (S9 mix) (reference 7.6.1-1).

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:

June 17,2019 - August 19, 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

21st July 1997

Deviations:

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

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:

Due to migration, the value was transferred to one of the current document's attachments

Test concentrations with justification for top dose:

5, 15.8, 50, 158, 500, 1580, 5000 µg/plate (with and without S9 mix)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: culture medium (DMSO)

- Justification for choice of solvent/vehicle: The selection of the solvent for this assay was based on the available information from a preliminary solubility test. DMSO showed best performance and was thus used for this experiment at a maximum concentration of 100 µL/plate.

Untreated negative controls:

Negative solvent / vehicle controls:

yes

Remarks:

H2O

True negative controls:

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA100, TA1535, without S9 mix

Untreated negative controls:

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

WP2 uvrA, without S9 mix

Untreated negative controls:

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

TA98, TA100, TA 1535, TA 1537, WP2uvrA, with S9 mix

Untreated negative controls:

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

Positive controls:

yes

Positive control substance:

other: 4-Nitro-o-phenylenediamine

Remarks:

TA98, TA1537, without S9 mix

Details on test system and experimental conditions:

NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 3 parallel plates were used for each concentration step of the test material and the positive controls. Twice as many solvent control plates were used for each bacterial strain.
- Number of independent experiments : 2

METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)

METHODS FOR MEASUREMENT OF CYTOTOXICITY
- background growth inhibition

Evaluation criteria:

A test material was to be defined as positive or mutagenic in this assay if
- the assay is considered valid and
- a biologically relevant increase in the mean number of revertants above a threshold of 2-fold (TA 98, TA 100, WP2 uvrA) or 3-fold (TA 1535, TA 1537) as compared to the concurrent negative controls is observed
- an increase exceeding the threshold at only one concentration is considered as biologically meaningful if reproduced in a second independent experiment
- a concentration-dependent increase is considered biologically meaningful if the threshold is exceeded at more than one concentration
A test material is defined as negative or non-mutagenic in this assay if
- the assay is considered valid and none of the above-mentioned criteria are met

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation, at the top concentration of 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation, at the top concentration of 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation, at the top concentration of 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation, at the top concentration of 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and time of the determination: Following treatment with the test item, precipitation of the test material on the agar plates occurred at concentrations > 5000 µg/plate.

Toxicity was observed in TA98, TA100 and TA1535 in the 1st series, and in TA98 and TA 1537 in the 2nd series, without metabolic activation, at the top concentration of 5000 µg/plate. The individual and summarized data are presented in the tables section.

Ames test:
- Individual plate counts : see table 1

HISTORICAL CONTROL DATA: see table 2

Table 1: Summary 1st Series

Metabolic Activation	Test Material	Concentr. [µg/plate]	Revertants per plate (Mean ± SD)
Metabolic Activation	Test Material	Concentr. [µg/plate]	TA 98	TA 100	TA 1535	TA 1537	WP2uvrA
Without activation	DMSO		37 ± 9	107 ± 11	34 ± 6	12 ± 5	24 ± 4
	Art. 851009	5.00	41 ± 7	104 ± 1	32 ± 4	11 ± 2	22 ± 1
		15.8	38 ± 6	104 ± 7	38 ± 11	10 ± 4	22 ± 6
		50.0	37 ± 10	110 ± 19	36 ± 4	11 ± 4	28 ± 5
		158	36 ± 4	107 ± 3	39 ± 7	10 ± 2	25 ± 4
		500	41 ± 7	103 ± 17	28 ± 9	10 ± 4	27 ± 7
		1580	46 ± 6	105 ± 4	24 ± 5	12 ± 3	25 ± 7
		5000	11 ± 3 E T	84 ± 6 T E	19 ± 6 E T	10 ± 3 E	26 ± 4 E
	NaN3	2.00		1675 ± 293	1027 ± 29
	NQO	2.00					1030 ± 96
	4-NOPD	60.0				102 ± 7
	4-NOPD	20.00	685 ± 59

With activation	DMSO		48 ± 1	133 ± 14	36 ± 3	11 ± 4	31 ± 5
	Art. 851009	5.00	44 ± 8	128 ± 7	30 ± 4	14 ± 7	34 ± 8
		15.8	40 ± 7	122 ± 23	28 ± 6	7 ± 1	30 ± 2
		50.0	44 ± 7	120 ± 22	34 ± 6	13 ± 5	36 ± 9
		158	41 ± 2	142 ± 14	30 ± 4	7 ± 2	32 ± 5
		500	52 ± 9	130 ± 11	29 ± 4	13 ± 5	37 ± 2
		1580	56 ± 7	140 ± 18	37 ± 7	12 ± 4	34 ± 6
		5000	72 ± 6 E	111 ± 4 E	28 ± 7 E	10 ± 4 E	37 ± 4 E
	2-AA	2.00	909 ± 165	1947 ± 81
	2-AA	10.0					312 ± 13
	2-AA	5.00			188 ± 33	650 ± 89

Key to Positive controls
NQO 4-Nitroquinoline-N-oxide

2-AA 2-Aminoanthracene

4-NOPD 4-Nitro-o-phenylendiamin

NaN3 Sodium azide

Key to Plate Postfix Codes

E Precipitation until end of experiment

T Toxicity = red. bact. background lawn

Table 2: Summary 2nd Series

Metabolic Activation	Test Material	Concentr. [ug/plate]	Revertants per plate (Mean ± SD)
Metabolic Activation	Test Material	Concentr. [ug/plate]	TA 98	TA 100	TA 1535	TA 1537	WP2uvrA
Without activation	DMSO		29 ± 6	111 ± 18	25 ± 4	11 ± 4	31 ± 5
	Art. 851009	50.0	35 ± 6	101 ± 12	24 ± 5	8 ± 4	19 ± 6
		158	30 ± 4	106 ± 7	26 ± 3	7 ± 1	28 ± 2
		500	28 ± 13	98 ± 12	26 ± 4	11 ± 1	29 ± 11
		1580	43 ± 11	107 ± 8	32 ± 6	9 ± 2	25 ± 2
		5000	12 ± 4 E T	82 ± 11 E	17 ± 4 E	5 ± 3 E	29 ± 9 E
	NaN3	2.00		1821 ± 111	949 ± 20
	NQO	2.00					1878 ± 94
	4-NOPD	20.0	573 ± 66
	4-NOPD	60.0				89 ± 12

With activation	DMSO		36 ± 4	124 ± 14	23 ± 4	13 ± 2	33 ± 4
		50.0	39 ± 4	124 ± 5	22 ± 4	10 ± 2	33 ± 8
		158	42 ± 9	119 ± 20	22 ± 3	8 ± 3	38 ± 3
		500	33 ± 7	125 ± 11	21 ± 7	11 ± 3	35 ± 11
		1580	43 ± 10	111 ± 6	20 ± 1	17 ± 4	40 ± 9
		5000	43 ± 3 E	136 ± 11 E	18 ± 6 E	11 ± 3 E	34 ± 3 E
	2-AA	5.00			161 ± 29	176 ± 52
	2-AA	2.00	339 ± 8	706 ± 90
	2-AA	10.00					152 ± 38

Key to Positive controls
NQO 4-Nitroquinoline-N-oxide

2-AA 2-Aminoanthracene

4-NOPD 4-Nitro-o-phenylendiamin

NaN3 Sodium azide

Key to Plate Postfix Codes

E Precipitation until end of experiment

T Toxicity = red. bact. background lawn

Table 3:Individual Values 1st Series

Without metabolic activation

Strain	Test Material	Concentr. [µg/plate]	Mean revertants per plate	Standard Deviation	Ratio treated / solvent	Individual revertants per plate
TA 98	Art 851009	5.00	40.7	6.5	1.1	34	47	41
		15.8	37.7	6.4	1.0	45	34	34
		50.0	36.7	10.4	1.0	40	45	25
		158	36.3	3.5	1.0	36	40	33
		500	41.0	6.6	1-1	47	42	34
		1580	46.0	6.1	1.3	42	43	53
		5000	11.0	2.6	0.3	12 E T	8 E T	13 E T
	DMSO		36.5	9.4		28	45	43	29	47	27

TA 100	Art 851009	5.00	103.7	0.6	1.0	104	104	103
		15.8	104.0	6.6	1.0	103	98	111
		50.0	109.7	19.4	1.0	132	97	100
		158	106.7	3.2	1.0	109	103	108
		500	103.3	16.6	1.0	119	86	105
		1580	105.3	3.8	1.0	101	107	108
		5000	84.0	6.1	0.8	81 T E	91 T E	80 T E
	DMSO		106.5	11.0		122	90	111	103	112	101

TA 1535	Art 851009	5.00	31.7	4.2	0.9	33	35	27
		15.8	38.3	11.2	1.1	48	26	41
		50.0	35.7	4.0	1.1	35	32	40
		158	38.7	6.7	1.2	37	46	33
		500	27.7	8.7	0.8	35	18	30
		1580	24.3	4.9	0.7	21	22	30
		5000	19.3	5.5	0.6	13 E T	23 E T	22 E T
	DMSO		33.5	6.3		35	34	23	30	40	39

TA 1537	Art 851009	5.00	11.0	1.7	0.9	9	12	12
		15.8	10.3	4.0	0.9	6	14	11
		50.0	10.7	3.8	0.9	8	9	15
		158	9.7	2.3	0.8	7	11	11
		500	10.3	4.0	0.9	14	6	11
		1580	11.7	2.5	1.0	12	14	9
		5000	10.0	2.6	0.8	11 E	12 E	7 E
	DMSO		11.8	4.8		14	8	8	20	13	8

WP2 uvrA	Art 851009	5.00	22.3	0.6	0.9	22	23	22
		15.8	21.7	6.1	0.9	15	27	235
		50.0	27.7	5.1	1.2	32	29	22
		158	25.0	4.0	1.0	21	25	29
		500	27.0	6.6	1.1	21	34	26
		1580	25.3	6.5	1.1	25	19	32
		5000	26.0	3.6	1.1	25 E	30 E	23 E
	DMSO		23.8	4.3		21	30	18	26	26	22

TA 98	4-NOPD	20.0	685.3	59.0	18.8	737	621	698
TA 100	NaN3	2.00	1675.0	292.9	15.7	1868	1819	1338
TA 1535	NaN3	2.00	1026.7	28.6	30.6	994	1039	1047
TA 1537	4-NOPD	60.0	102.3	7.4	8.6	105	94	108
WP2 uvrA	NQO	2.00	1029.7	96.0	43.2	1000	952	1137

Key to Positive controls

4-NOPD 4-Nitro-o-phenylendiamin

NaN3 Sodium azide

NQO 4-Nitroquinoline-N-oxide

Key to Plate Postfix Codes

E Precipitation until end of experiment

T Toxicity = red. bact. background lawn

With metabolic activation

Strain

Test Material

Concentr.

[ug/plate]

Mean revertants per plate

Standard Deviation

Ratio treated / solvent

Individual revertants per plate

TA 98

Art 851009

5.00

43.7

8.1

0.9

15.8

39.7

7.0

0.8

50.0

43.7

7.1

0.9

158

41.3

1.5

0.9

500

52.0

8.9

1.1

1580

56.0

6.6

1.2

5000

72.0

5.6

1.5

71 E

67 E

78 E

DMSO

47.5

1.0

TA 100

Art 851009

5.00

128.0

7.0

1.0

136

123

125

15.8

122.3

23.5

0.9

148

102

117

50.0

120.3

22.1

0.9

141

123

158

142.3

13.6

1.1

155

144

128

500

130.0

10.6

1.0

138

134

118

1580

140.3

18.1

1.1

121

157

143

5000

111.3

3.5

0.8

115 E

111 E

108 E

DMSO

132.7

14.0

128

119

159

124

131

135

TA 1535

Art 851009

5.00

30.0

3.6

0.8

15.8

28.3

5.7

0.8

50.0

34.3

5.5

1.0

158

29.7

3.8

0.8

500

29.0

3.6

0.8

1580

37.0

7.0

1.0

5000

28.3

6.8

0.8

26 e

23 E

36 E

DMSO

35.7

2.8

TA 1537

Art 851009

5.00

13.7

7.4

1.2

15.8

6.7

0.6

50.0

12.7

5.0

1.2

158

6.7

1.5

0.6

500

13.0

5.3

1.2

1580

12.0

3.6

1.1

5000

10.0

3.6

0.9

13 E

11 E

6 E

DMSO

11.0

4.1

WP2 uvrA

Art 851009

5.00

34.3

8.0

1.1

15.8

30.3

1.5

1.0

50.0

35.7

9.1

1.2

158

32.0

4.6

1.0

500

37.0

1.7

1.2

1580

33.7

6.0

1.1

5000

37.0

4.0

1.2

33 E

37 E

41 E

DMSO

30.7

4.7

TA 98

2-AA

2.00

908.7

165.1

19.1

732

1059

935

TA 100

2-AA

2.00

1946.7

80.5

14.7

1916

1886

2038

TA1535

2-AA

5.00

188.0

32.7

5.3

225

163

176

TA 1537

2-AA

5.00

649.7

88.8

59.1

629

747

573

WP2 uvrA

2-AA

10.00

312.3

13.2

10.2

298

324

315

Key to Positive controls

2-AA 2-Aminoanthracene

Key to Plate Postfix Codes

E Precipitation until end of experiment

Table 4:Individual Values 2nd Series

Without metabolic activation

Strain	Test Material	Concentr. [µg/plate]	Mean revertants per plate	Standard Deviation	Ratio treated / solvent	Individual revertants per plate
TA 98	Art 851009	50.0	34.7	5.5	1.2	29	40	35
		158	30	4.4	1.0	25	33	32
		500	27.7	12.7	1.0	36	34	13
		1580	42.7	11.0	1.5	42	32	54
		5000	11.7	3.5	0.4	12 E T	15 E T	8 E T
	DMSO		29.0	6.0		32	37	32	25	28	20

TA 100	Art 851009	50.0	101.3	11.6	0.9	107	109	88
		158	106.3	6.8	1.0	104	101	114
		500	98.0	11.8	0.9	111	88	95
		1580	107.0	7.9	1.0	116	101	104
		5000	81.7	10.7	0.7	76 E	75 E	94 E
	DMSO		110.8	18.3		102	139	90	116	96	122

TA 1535	Art 851009	50.0	23.7	4.7	0.9	22	20	29
		158	26.0	2.6	1.0	23	27	28
		500	26.0	3.6	1.0	25	30	23
		1580	31.7	5.8	1.3	25	35	35
		5000	16.7	5.1	0.7	11 E	21 E	18 E
	DMSO		25.2	4.0		29	29	26	22	26	19

TA 1537	Art 851009	50.0	8.0	3.6	0.7	11	4	9
		158	7.3	1.2	0.6	8	6	8
		500	11.3	0.6	1.0	11	11	12
		1580	9.3	2.3	0.8	8	12	8
		5000	5.0	3.0	0.4	2 E	5 E	8 E
	DMSO		11.3	4.0		9	12	8	19	11	9

WP2 uvrA	Art 851009	50.0	19.3	6.0	0.6	25	20	13
		158	28.0	1.7	0.9	26	29	29
		500	29.0	10.6	0.9	25	41	21
		1580	25.3	2.1	0.8	23	26	27
		5000	29.3	9.3	0.9	19 E	32 E	37 E
	DMSO		31.3	5.5		29	26	41	32	33	27

TA 98	4-NOPD	20.0	573.0	66.3	19.8	647	553	519
TA 100	NaN3	2.00	1821.0	110.8	16.4	1898	1871	1694
TA 1535	NaN3	2.00	949.0	20.2	37.7	957	964	926
TA 1537	4-NOPD	60.0	88.7	12.0	7.8	88	101	77
WP2 uvrA	NQO	2.00	1878.3	93.5	59.9	1791	1977	1867

Key to Positive controls

4-NOPD 4-Nitro-o-phenylendiamin

NaN3 Sodium azide

NQO 4-Nitroquinoline-N-oxide

Key to Plate Postfix Codes

E Precipitation until end of experiment

T Toxicity = red. bact. background lawn

With metabolic activation

Strain

Test Material

Concentr.

[µg/plate]

Mean revertants per plate

Standard Deviation

Ratio treated / solvent

Individual revertants per plate

TA 98

Art 851009

50.0

38.7

3.5

1.1

158

42.3

8.5

1.2

500

32.7

6.5

0.9

1580

43.3

9.7

1.2

5000

43.3

2.5

1.2

46 E

43 E

41 E

DMSO

35.5

3.6

TA 100

Art 851009

50.0

123.7

5.1

1.0

125

128

118

158

118.7

19.6

1.0

137

121

500

125.3

10.5

1.0

115

136

125

1580

110.7

5.5

0.9

105

111

116

5000

135.7

11.0

1.1

132 E

127 E

148 E

DMSO

124.0

14.3

151

124

119

121

108

TA 1535

Art 851009

50.0

22.3

4.0

1.0

158

22.0

3.0

0.9

500

20.7

7.0

0.9

1580

20.0

1.0

0.9

5000

18.3

5.9

0.8

25 E

16 E

14 E

DMSO

23.2

4.3

TA 1537

Art 851009

50.0

10.0

1.7

0.8

158

8.0

3.0

0.6

500

11.0

3.5

0.8

1580

16.7

3.8

1.3

5000

11.0

3.0

0.8

11 E

8 E

14 E

DMSO

13.0

1.7

WP2 uvrA

Art 851009

50.0

33.3

7.6

1.0

158

38.0

2.6

1.1

500

34.7

10.8

1.0

1580

39.7

9.0

1.2

5000

33.7

2.9

1.0

32 E

37 E

32 E

DMSO

33.2

4.0

TA 98

2-AA

2.00

339.0

7.5

9.5

331

340

346

TA 100

2-AA

2.00

706.3

89.8

5.7

698

800

621

TA1535

2-AA

5.00

160.7

28.9

6.9

194

143

145

TA 1537

2-AA

5.00

175.7

52.0

13.5

216

117

194

WP2 uvrA

2-AA

10.00

152.0

38.1

4.6

108

175

173

Key to Positive controls

2-AA 2-Aminoanthracene

Key to Plate Postfix Codes

E Precipitation until end of experiment

Table 5: Historical Data

The historical data have been obtained in experiments between 01/2018 and 12/2018.

Negative Controls

Strain	TA 98		TA 100		TA 1535		TA 1537		WP2 uvrA
S9 Mix	Without	With	Without	With	Without	With	Without	With	Without	With
Compound	Solvent	Solvent	Solvent	Solvent	Solvent	Solvent	Solvent	Solvent	Solvent	Solvent
Total Plates	618	608	624	612	461	456	480	473	576	575
Number of Values	121	119	121	121	82	82	86	85	111	111
Minimum	9	11	85	96	11	7	5	5	19	19
Maximum	46	51	144	158	37	44	18	16	51	58
Mean	28	33	112	124	20	18	9	10	33	38
Standard Deviation	6.5	7.8	11.5	12.9	5.7	6.2	2.4	2.5	5.8	7.6

Postive controls

Strain	TA 98		TA 100		TA 1535		TA 1537		WP2 uvrA
S9 Mix	Without	With	Without	With	Without	With	Without	With	Without	With
Compound	DAUN	2-AA	NaN3	2-AA	NaN3	2-AA	9-AA	2-AA	NQO	2-AA
Total Plates	311	304	312	306	231	228	240	238	288	288
Number of Values	121	119	121	121	82	82	86	85	111	111
Minimum	67	107	363	447	162	74	85	72	294	124
Maximum	1243	1862	2910	5235	2637	298	4040	660	3170	1494
Mean	365	616	1603	1801	853	166	1403	282	1881	364
Standard Deviation	232.7	380.7	369.1	1045.8	259.6	53.8	838.8	137.6	386.3	157.3

Conclusions:

Under the experimental conditions reported here, the test item did not induce gene mutations by base-pair or frameshift changes in the genome of the strains used. Therefore, it was concluded that with and without addition of S9 mix as the exogenous metabolizing system, the test item was not mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation test.

Executive summary:

The test item was examined according to OECD TG 471 for its mutagenic activity in an in vitro bacterial reverse mutation test employing Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2 uvrA as indicator organisms.

The plate incorporation test with and without addition of liver S9 mix from Phenobarbital/(beta-Naphthoflavone-pretreated rats was used. In this study, two experimental series were performed. In the experiments with S9 mix, 10% and 20% S9 in the S9 mix were used.

Treatments of all tester strains were performed using test item formulations prepared in DMSO in the absence and in the presence of S9 mix, using final concentrations between 5 and 5000 µg/plate, vehicle and positive controls.

The mean numbers of revertant colonies of the current negative controls were within the range of historical negative control values.

The strain-specific positive controls, namely sodium azide, 4-nitroquinolin-N-oxide and 4-Nitro-o-phenylenediamine in the absence of S9 mix, yielded the expected mutant frequencies that were greatly exceeding the negative controls. The genotype of the tester strains used was thus confirmed. 2-Aminoanthracene which requires metabolic activation was strongly mutagenic. This indicates that the exogenous metabolizing system used in the present investigation (S9 mix) was active. Thus, the study is considered valid.

Following treatment with the test item, precipitation of the test material on the agar plates occurred at concentrations > 5000 µg/plate. Toxicity was observed in TA98, TA100 and TA1535 in the 1st series, and in TA98 and TA 1537 in the 2nd series, without metabolic activation, at the top concentration of 5000 µg/plate.

Under the conditions described, there were no relevant increases in revertant numbers observed after exposure to the test item in the absence and presence of S9 mix.

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:: no study available

Additional information

Ames Test

The mean numbers of revertant colonies of the current negative controls were within the range of historical negative control values.

Under the conditions described, there were no relevant increases in revertant numbers observed after exposure to the test item in the absence and presence of S9 mix.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Thus, the test item is considered not to be classified for genotoxicity under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) No 2020/1182.

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