Diisobutyl phthalate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP. Test conducted according to standard Ames test system. Available as a published report, reliable with restrictions.

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity Testing of Di(2-ethylhexyl)phthalate and Related Chemicals in Salmonella

Author:

Zeiger E, Haworth S, Mortelmans K, Speck W

Year:

1985

Bibliographic source:

Environmental Mutagenesis 7:213-232

Materials and methods

Principles of method if other than guideline:

Test system according to Ames, B.N. et al., Mut. Res. 31, 347-364

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diisobutyl phthalate

EC Number:

201-553-2

EC Name:

Diisobutyl phthalate

Cas Number:

84-69-5

Molecular formula:

C16H22O4

IUPAC Name:

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

Details on test material:

Source: Eastman

Method

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Overnight culture

Metabolic activation:

with and without

Metabolic activation system:

9000g supernatant of liver homogenates (S-9 fraction) from Aroclor 1254-induced male Sprague-Dawley rats (RLI) or male Syrian hamsters (HLI).

Test concentrations with justification for top dose:

0 (control), 33, 100, 333, 1000, 3333, 10000 µg/plate

Vehicle / solvent:

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

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

other: TA1537 & TA100: sodium azide, TA98: 4-nitro-o-phenylenediamine, TA1537: 9-aminoacridine

Details on test system and experimental conditions:

Incubation temperature: 37°C
Incubation time: 48 h

Evaluation criteria:

histidine-revertant colonies

Statistics:

Not reported

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not applicable

Untreated negative controls validity:

valid

Positive controls validity:

not specified

Additional information on results:

No additional information

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

	TA100						TA1535						TA1537						TA98
Dose	NA		10% HLI		10% RLI		NA		10% HLI		10% RLI		NA		10% HLI		10% RLI		NA		10% HLI		10% RLI
µg/plate	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0	135	5.6	182	9.6	178	17.4	28	2.4	12	3.3	8	1.9	9	2.1	10	1.3	9	2.6	16	1.2	41	5.2	32	2.7
100	143	0.9	188	11.8	161	13.3	23	1.2	11	1.2	13	0.3	6	1.7	11	2.2	8	1.5	18	0.3	38	3.3	34	5.2
333	148	2.3	179	3.3	174	7.5	28	2.7	14	1.8	13	2.1	7	0.3	8	0.3	8	0.9	14	2	34	0.9	34	1.9
1000	144	4.6	189	5.2	162	4	27	2.4	13	0.3	15	1.2	7	1.9	8	0.3	9	1.9	20	1.2	30	2.4	37	4.9
3333	151	11.6	186	6.9	179	5.6	27	4.3	13	2.1	13	2	6	2.3	7	2.9	7	1.5	21	2	36	3.9	26	2.6
10000	140	1.2	170	3.2	146	7	27	1.9	12	1	10	2.1	6	0	6	2	5	2	19	2.1	20	2.9	19	2.9

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Diisobutyl phthalate is not genotoxic with or without metabolic activation to Salmonella strains TA1535, TA1537, TA98 and TA100.

Executive summary:

A non-GLP test conducted according to the standard Ames test system found that Diisobutyl phthalate is not genotoxic with or without metabolic activation to Salmonella strains TA1535, TA1537, TA98 and TA100.