Bis(3,5,5-trimethylhexanoyl) peroxide

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:

weight of evidence

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets general accepted scientific standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

: strain TA 102 is missing; detection of cross-linking and oxidizing substances not possible; no justification for maximal test concentration

Principles of method if other than guideline:

according the method of Ames et al. 1975

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Bis(3,5,5-trimethylhexanoyl) peroxide

EC Number:

223-356-0

EC Name:

Bis(3,5,5-trimethylhexanoyl) peroxide

Cas Number:

3851-87-4

Molecular formula:

C18H34O4

IUPAC Name:

3,5,5-trimethylhexanoyl 3,5,5-trimethylhexaneperoxoate

Details on test material:

- Name of test material (as cited in study report): Trigonox 36-CD-75 (bis(3,5,5-trimethylhexanoyl) peroxide)
- Substance type: organic peroxide
- Physical state: clear colourless liquid
- Analytical purity: 75% solution in aromatic free mineral spirit
- Storage condition of test material: -20°C

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):

n.a.

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

spot test: 0 and 3 mg/ 30µl DMSO
plate incorporation assay: 0, 0.2, 2, 20, 500 µg/0.1 ml DMSO/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

Migrated to IUCLID6: N-methyl-N-nitro-N-nitrosoguanidine, 4-aminobiphenyl, 9-aminoacridine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); spotting onto the plate surface
DURATION
- Exposure duration: 2 days

SELECTION AGENT (mutation assays): histidine

All determinations were made in duplicate and appropriate controls were included in each assay.

Statistics:

no data

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Results of the spot test

Trigonox 36-CD-75 spotted/plate (mg/30 µl DMSO)	S9 (µl/plate)	His^+revertants in each of two plates with
		TA 1535	TA 1537	TA 98	TA 100
0	50	0;1	4;4	24;24	15;15
3	50	4;6	4;9	25;35	15;22
0	0	0;2	1;0	8;12	9;11
3	0	2;8	0;2	4;4	18;19

 

 

Table 2: Results of the plate incorporation assay

Trigonox 36-CD-75 (µg/plate)	S9 (µl/plate)	His^+revertants in each of two plates with
		TA 1535	TA 1537	TA 98	TA 100
0	50	3;7	5;5	18;20	35;36
0.2	50	6;7	3;6	15;22	21;27
2	50	7;11	4;7	10;16	23;28
20	50	9;11	5;7	12;16	24;33
500	50	6;6	4;7	20;26	27;30
0	0	3;6	7;7	11;16	27;27
0.2	0	5;7	6;8	8;13	24;26
2	0	8;10	4;9	7;10	27;28
20	0	6;8	2;4	8;11	19;31
500	0	4;6	3;5	9;11	22;25

 

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Under conditions of this study the test item did not reveal mutagenic activity up to non-inhibitory levels in the Salmonella/microsome mutagenicity test either with or without metabolic activation.

Executive summary:

In a reverse gene mutation assay in bacteria, strains TA1535, TA1537, TA100 and TA98 of S. typhimurium were exposed to bis (3,5,5-trimethylhexanoyl) peroxide (75% solution in aromatic free mineral spirit) at concentrations of 0, 0.2, 2, 20 and 500 µg/plate in the presence and absence of mammalian metabolic activation (S9 mix) in a plate incorporation. In addition a spot test was conducted with 0 and 3 mg/30 µl DMSO spotted per plate in the absence and presence of S9-mix.

Up to the highest concentration tested (500 µg/plate and 3 mg/spot) no cytotoxic effects were observed. There was no evidence of induced mutant colonies over background. This study is considered as acceptable.