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EC number: 223-356-0 | CAS number: 3851-87-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 1 977
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
- 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
Constituent 1
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.
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