Reaction mass of 4-methylpentane-2,2-diyl dihydroperoxide, dioxybis-4-methylpentane-2,2-diyl dihydroperoxide and methylisobutylketon

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no E.coli strain tested

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-[(2-hydroperoxy-4-methylpentan-2-yl)peroxy]-4-methylpentane-2-peroxol; 4-methylpentan-2-one; 4-methylpentane-2,2-diperoxol

EC Number:

942-932-9

Cas Number:

37206-20-5

Molecular formula:

Reaction mass of C6H14O4 and C12H26O6 and C6H12O

IUPAC Name:

2-[(2-hydroperoxy-4-methylpentan-2-yl)peroxy]-4-methylpentane-2-peroxol; 4-methylpentan-2-one; 4-methylpentane-2,2-diperoxol

additive 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:

diisobutyl phthalate

Test material form:

liquid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9 mix Aroclor 1254 induced (rat liver)

Test concentrations with justification for top dose:

0, 0.0005, 0.001, 0.002, 0.1 µL test liquid/0.1 mL acetone/plate (1st test)
0, 0.0005, 0.001, 0.002, 0.01 µL test liquid/0.1 mL acetone/plate (2nd test)
0, 0.1, 0.25, 0.5, 1.0 (positive control) µg 2-AA/0.1 mL DMSO/plate

Vehicle / solvent:

DMSO and aceton

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

All strains with and without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 3 days at 37 °C

SELECTION AGENT (mutation assays): L-Histidine

NUMBER OF REPLICATIONS: 3

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

not valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

not valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

not valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

not valid

Any other information on results incl. tables

The addition of 2 -aminoanthracene showed a significant bacterial growth by the addition of S-9 mix, no significant bacterial growth was observed without the addition of S-9 mix. The amount of S-9 mix used was not optimal for the metabolic activation of 2 -AA. The positive control was not valid in this test.

Applicant's summary and conclusion

Conclusions:

The genetic toxicity of the test item was determined in an Ames test equivalent to OECD guideline 471. No genetic toxicity was observed in this study.

Executive summary:

The mutagenic activity of the test item was tested in a study equivalent to OECD guideline 471. A set of 5 histidine requiring mutants of S. typhimurium (TA1535, TA1537, TA 1538, TA 98 and TA100) were used in the Ames-test with and without metabolic activation.

Doses of 0, 0.0005, 0.001, 0.002, 0.1 µL test liquid/0.1 mL acetone/plate (1st test) and 0, 0.0005, 0.001, 0.002, 0.01 µL test liquid/0.1 mL acetone/plate (2nd test) were tested. The strains were incubated over a period of 3 days at 37 °C. Incorporation of the test substance up to non-inhibitory levels did not increase the number of his+ revertants in any of the five tester strains, either in the presence or in the absence of the liver microsome activation system. It was concluded that the present results did not reveal mutagenic acitivity in the Salmonella mutagenicity test.