Bis(2-propylheptyl) phthalate

Genetic toxicity: in vitro

Administrative data

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:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-propylheptyl) phthalate

EC Number:

258-469-4

EC Name:

Bis(2-propylheptyl) phthalate

Cas Number:

53306-54-0

Molecular formula:

C28H46O4

IUPAC Name:

1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate

Test material form:

liquid

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9-mix

Test concentrations with justification for top dose:

20, 100, 500, 2500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Acetone

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene; 2.5 µg dissolved in DMSO for TA 100, TA 98, TA 1537 and TA 1535

Remarks:

with metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine; 10 µg dissolved in DMSO for TA 98

Remarks:

without metabolic activation

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without metabolic activation Migrated to IUCLID6: 100 µg dissolved in DMSO for TA 1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation


DURATION
- Preincubation period: 20 min, 37°C
- Exposure duration: 48 h, 37°C


NUMBER OF REPLICATIONS: 3


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA1535, TA1537, TA98, TA100

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: A precipitation was found from about 500 µg/plate onward

Remarks on result:

other: all strains/cell types tested

Any other information on results incl. tables

Results standard plate assay:

Dose µg/plate	metabolic activation	TA98			TA100			TA1535			TA1537
		Trial 1	Trial 2	Trial 3	Trial 1	Trial 2	Trial 3	Trial 1	Trial 2	Trial 3	Trial 1	Trial 2	Trial 3
0	+	50	38	38	128	118	123	15	20	24	14	17	10
20	+	46	35	30	106	117	122	14	15	26	15	15	18
100	+	34	27	49	130	127	101	21	17	14	8	19	8
500	+	40	31	30	108	111	117	9	22	20	11	9	16
2500	+	34	35	51	147	125	152	10	-	11	10	11	7
5000	+	32	33	40	144	124	125	14	11	18	11	16	8
2.5 µg 2-Aminoanthracene	+	628	591	599	1080	997	1076	146	80	92	81	93	102
0	-	33	31	31	118	144	129	17	22	13	13	12	14
20	-	18	35	33	132	153	127	10	20	29	13	13	13
100	-	31	27	33	128	127	-	17	11	24	16	17	11
500	-	34	25	36	120	120	137	16	17	17	9	11	14
2500	-	40	36	28	142	138	167	24	28	21	9	13	8
5000	-	33	29	27	157	155	162	19	20	20	9	7	8
5 µg MNNG	-				1560	1700	1997	1514	1650	1345
10 µg 4-Nitro-o-phenylendiamin	-	640	533	386
100 µg 9-amninoacridine	-										371	430	541

Preincubation test:

Dose µg/plate	metabolic activation	TA98			TA100			TA1535			TA1537
		Trial 1	Trial 2	Trial 3	Trial 1	Trial 2	Trial 3	Trial 1	Trial 2	Trial 3	Trial 1	Trial 2	Trial 3
0	+	48	46	31	112	98	95	16	15	19	9	6	11
20	+	49	48	43	88	118	106	14	16	14	14	15	9
100	+	32	47	45	73	91	95	18	27	17	9	9	4
500	+	42	48	47	110	86	81	11	20	14	11	11	10
2500	+	47	59	49	104	91	92	4	12	18	9	6	13
5000	+	53	48	56	94	93	108	20	13	18	7	10	9
2.5 µg 2-Aminoanthracene	+	599	649	624	585	529	687	92	102	108	82	76	80
0	-	49	55	47	136	95	96	19	19	20	13	11	11
20	-	50	60	35	105	134	103	15	23	22	8	12	5
100	-	35	56	43	103	100	104	26	16	22	13	16	12
500	-	38	47	41	107	112	110	25	19	16	7	13	9
2500	-	43	32	47	89	94	100	15	23	17	6	12	14
5000	-	50	49	38	122	121	100	12	23	20	12	12	15
5 µg MNNG	-				555	690	629	911	825	780
10 µg 4-Nitro-o-phenylendiamin	-	1340	1460	1450
100 µg 9-amninoacridine	-										581	692	519