Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatetungstatephosphate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation toxicity study was performed to determine the mutagenic nature of Pigment Violet 1 (EC name: Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatetungstatephosphate) using Salmonella typhimurium strains TA100, TA1535, TA97and TA98. Salmonella/microsome test was performed both in the absence and presence of liver S-9 obtained from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters. Preincubation assay was performed at dose levels of 0.0 (DMSO), 33.0, 100.0, 333.0, 1000.0, 2000.0, 3333.0, 5000.0, 10000.0 µg/plate. The plates were preincubated for 20 mins and incubated further for 48 hrs chemical exposure. Concurrent solvent and positive controls were also included in the study. Pigment violet 1 did not to induce mutation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA 97 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

 

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Gene mutation toxicity study was performed to determine the mutagenic nature of Pigment Violet 1 using Salmonella typhimurium strains

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

- Name of test material: C.I. Pigment Violet 1
- IUPAC name: Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatetungstatephosphate
- Molecular formula: C28H35MoN2O13PS
- Molecular weight (if other than submission substance): 766.573 g/mol
- Smiles : CCN(CC)C1=CC2=C(C=C1)C(=C3C=CC(=[N+](CC)CC)C=C3O2)C4=CC=CC=C4C(=O)O.OP(=O)(O)[O-].OS(=O)(=O)O.O=[Mo]=O
- Inchi : 1S/C28H30N2O3.Mo.H3O4P.H2O4S.2O/c1-5-29(6-2)19-13-15-23-25(17-19)33-26-18-20(30(7-3)8-4)14-
16-24(26)27(23)21-11-9-10-12-22(21)28(31)32;;2*1-5(2,3)4;;/h9-18H,5-8H2,1-4H3;;(H3,1,2,3,4);(H2,1,2,3,4);;
- Substance type: Organic
- Physical state: Solid powder (purple)

Target gene:

Histidine

Species / strain / cell type:

S. typhimurium, other: TA100, TA1535, TA97, TA98

Remarks:

LAB 1

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

The S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared

Test concentrations with justification for top dose:

LAB 1: 0, 33, 100, 333, 1000, 2000, 3333, 5000 or 10000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2-Aminoanthracene (All strains + S9); 4-Nitro-o-phenylenediamine (TA98; -S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: Triplicate

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:

OTHER: No data available

Rationale for test conditions:

No data

Evaluation criteria:

An individual trial was judged mutagenic (+) if a dose-related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic C+W) if a low-level dose response was seen. A trial was considered questionable (?) if a dose-related increase was judged insufficiently high to justify a call of "+W," if only a single dose was elevated over the control, or if a non-dose-related increase was seen.

The chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials.

It chemical was considered to be questionable (?) if a reproducible increase of his+ revertants did not meet the criteria for either a " + " or " + W," or if only single doses produced an increase in his+ revertants in repeat trials.

Statistics:

No data

Species / strain:

S. typhimurium, other: TA100, TA1535, TA97, TA98

Remarks:

LAB 1

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:

No data

Remarks on result:

other: No mutagenic potential

Table: Mutagenicity of Pigment violet 1

Lab 1:

Dose (µg/plate)	TA100
	-S9		10% HLI		30% HLI		10% RLI		30% RLI
	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0	109	11.7	106	2.3	112	9.1	113	3.4	140	2.6
33	108	10.3			105	1.5			120	2.5
100	92	2.0	99	3.0	120	8.8	106	4.5	112	10.2
333	105	6.0	91	7.2	129	1.9	95	9.0	124	6.1
1000	82s	10.1	83	7.4	113s	7.9	89	7.3	97s	6.2
2000
3333	63s	2.0	66s	7.3	70s	4.7	72s	3.5	77s	3.7
5000
10000			12	2.0			17	1.8
Positive control	1196	36.6	1211	41.5	736	7.5	1191	46.2	547	27.1

 

Dose (µg/plate)	TA1535
	-S9		5% HLI		10% HLI		30% HLI		5% RLI		10% RLI		30% RLI
	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0	23	1.5	15	1.2	15	2.3	16	2.3	16	5.2	15	1.5	14	2.8
33							13	1.9					14	3.0
100	22	3.2	16	2.3	9	1.7	12	2.5	19s	2.3	13	1.5	12	0.7
333	29s	2.9	11	1.5	11s	2.3	13	0.9	17s	1.7	13s	1.8	15	1.8
1000	17s	1.2	18s	2.9	13s	0.9	11	2.1	19s	2.3	17s	1.3	7	1.2
2000	23s	2.7	20s	3.0	14s	3.8			25s	2.9	19s	4.0
3333	20s	3.8	23s	1.2	21s	3.9	10s	2.6	19s	0.6	22s	0.3	15s	4.1
5000	15s	2.4	20s	4.1	20s	3.5			16s	4.4	19s	0.3	15s	4.1
10000	12s	0.7	13s	1.2	10s	0.9			14s	2.1	11s	0.0
Positive control	1041	16.2	181	8.0	118	5.8	224	14.9	108	2.1	121	3.6	161	3.7

 

Dose (µg/plate)	TA97
	-S9		10% HLI		30% HLI		10% RLI		30% RLI
	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0	114	3.7	129	6.7	156	5.5	134	9.0	189	9.7
33	119	6.4			162	4.8			185	1.2
100	102	9.3	124	6.8	164	5.4	142	4.6	155	8.5
333	105	10.8	93	2.9	162	10.7	108	3.9	170	3.5
1000	100	10.4	79	4.4	126	2.0	88	5.0	120	8.2
2000
3333	11s	7.7	32s	15.5	118s	14.2	51s	2.1	104s	3.8
5000
10000			10	1.0			15	2.0
Positive control	797	16.2	747	12.3	542	12.2	902	43.0	548	18.2

 

Dose (µg/plate)	TA98
	-S9		10% HLI		30% HLI		10% RLI		30% RLI
	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0	16	1.7	34	2.3	34	3.2	37	3.2	34	5.0
33	19	4.9			29	3.2			32	5.0
100	11	1.8	44	4.6	31	4.7	36	3.8	32	1.2
333	10	2.0	22	0.6	43	2.1	30	6.4	37	2.8
1000	8	1.3	20	2.0	20	3.2	19	1.0	13	1.2
2000
3333	8	3.0	13	2.3	14	1.5	15	1.2	15s	2.3
5000
10000			10	0.9			7	2.9
Positive control	1594	95.7	1341	42.6	653	12.2	1397	38.8	449	13.0

 

Lab 2:

Dose (µg/plate)	TA100						TA1535
	-S9		10% HLI		30% HLI		-S9		10% RLI		30% RLI
	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0	128	1.5	110	0.7	115	7.2	25	2.2	8	2.0	9	1.9
33	116	12.3	112	5.8	108	4.7	24	3.2	11	2.0	8	1.9
100	100	12.5	133	10.7	122	9.0	31	2.9	5	0.6	11	3.3
333	100	5.0	115	0.3	101	8.2	25	3.8	6	0.9	9	2.1
1000	97	9.4	105	6.9	95	7.5	16	3.8	7	0.9	7	3.0
3333	60	1.5	88	5.9	79	10.5	15	1.5	10	0.3	10	0.6
Positive control	531	0.6	1828	104.6	606	14.9	604	10.2	407	19.1	129	5.6

 

Dose (µg/plate)	TA1537						98
	-S9		10% HLI		30% HLI		-S9		10% RLI		30% RLI
	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0	5	1.2	7	1.2	5	1.2	17	0.6	24	3.8	25	3.2
33	11	2.0	27	1.5	29	7.8	15	1.7	30	2.1	29	2.7
100	5	0.7	6	1.5	11	1.5	15	1.7	30	2.1	29	2.7
333	4	0.9	7	2.6	5	0.6	16	0.9	24	2.0	35	1.3
1000	6	1.7	7	0.7	6	1.3	13	1.7	12	1.3	12	2.3
3333	4	0.3	6	3.1	4	0.3	14	1.2	13	0.3	14	0.9
Positive control	630	83.2	204	34.3	125	0.7	864	41.2	1270	51.2	378	23.2

 

s: slight clearing of background lawn

Conclusions:

Pigment violet 1 did not induce mutation in Salmonella typhimurium strains TA98, TA100, TA 1537 and TA 97 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of Pigment Violet 1 (EC name: Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatetungstatephosphate) using Salmonella typhimurium strains TA100, TA1535, TA97and TA98. Salmonella/microsome test was performed both in the absence and presence of liver S-9 obtained from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters. Preincubation assay was performed at dose levels of 0, 33, 100, 333, 1000, 2000, 3333, 5000, 10000 µg/plate in lab 1. The plates were preincubated for 20 mins and incubated futher for 48 hrs chemical exposure. Concurrent solvent and positive controls were also included in the study. Pigment violet 1did not induce gene mutation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA 97 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

 

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:

Peer reviewed publication was reviewed to determine the mutagenic nature of Pigment Violet 1. The study is as mentioned below:

Zeiger et al (Environmental Mutagenesis, 1987) performed gene mutation toxicity study to determine the mutagenic nature of Pigment Violet 1 (EC name: Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatetungstatephosphate) using Salmonella typhimurium strains TA100, TA1535, TA97, TA98 (LAB 1) and strains TA 1535, TA 1537, TA 98 and TA 100 (LAB 2). Salmonella/microsome test was performed both in the absence and presence of liver S-9 obtained from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters. Preicubation assay was performed at dose levels of 0.0 (DMSO), 33.0, 100.0, 333.0, 1000.0, 2000.0, 3333.0, 5000.0, 10000.0 µg/plate (lab 1) and 0.0 (DMSO), 33.0, 100.0, 333.0, 1000.0, 3333.0 µg/plate (lab 2). The plates were preincubated for 20 mins and incubated further for 48 hrs chemical exposure. Concurrent solvent and positive controls were also included in the study. Pigment violet 1 did not induce mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA 1537 and TA 97 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Based on the available data, Pigment violet 1 does not exhibit gene mutation ability. Thus, the chemical is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.

 

Justification for classification or non-classification

Based on the available data, Pigment violet 1 (CAS no 1326 -03 -0) does not exhibit gene mutation ability. Thus, the chemical is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.