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Toxicological information

Genetic toxicity: in vitro

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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

Reference
Name:
Unnamed
Type:
Constituent
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.