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EC number: 211-687-3 | CAS number: 686-31-7
- 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:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a: GLP, OECD 471 Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- tert-pentyl 2-ethylperoxyhexanoate
- EC Number:
- 211-687-3
- EC Name:
- tert-pentyl 2-ethylperoxyhexanoate
- Cas Number:
- 686-31-7
- Molecular formula:
- C13H26O3
- IUPAC Name:
- 2-methylbutan-2-yl 2-ethylhexaneperoxoate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- The test substance was identified as follows:
. name: t-AMYL PEROXYETHYL-2-HEXANOATE
. batch number: 616-9809-715 (19/09/98)
. description:
- at receipt: whitish liquid
-on the test article description: colourless or slightly yellowish liquid
. container: one plastic flask
. date of receipt: 16 December 1998
. storage conditions: at +4°C and protected from light
. expiry date: June 1999.
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- : Rat S9 mix. Liver S9 homogenate was prepared from rats that have been induced with Arochlor 1254
- Test concentrations with justification for top dose:
- Since the test substance was toxic in the preliminary test, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines.
Without S 9 the following doses were chosen: 156.25, 312.5, 625, 1250 and 2500 pg/plate: for all tester strains in both experiments.
With S9: The selected treatment-levels were as follows: 156.25, 312.5, 625, 1250 and 2500 µg/plate: for the TA 1535, TA 100 and TA 102 strains in the first experiment / 78.125, 156.25, 312.5, 625 and 1250 µg/plate: for the TA 1537 and TA 98 strains in the first
experiment / 312.5, 625, 1250, 2500 and 3125 µg/plate: for the TA 1535, TA 100 and TA 102 strains in the second experiment / 312.5, 625, 750, 1250 and 1500 µg/plate: for the TA 1537 and TA 98 strains in the second experiment. - Vehicle / solvent:
- - Vehicle used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see below, details on test system and conditions
- Details on test system and experimental conditions:
- DETERMINATION OF CYTOTOXICITY (preliminary range-finding test)
- Test: in TA 98, TA 100 and TA 102 strains, with or without S9 mix ; 6 dose-levels (one plate/dose level)
- Method: relative total growth (decrease in the number of revertant colonies and/or a thinning of the bacterial lawn);
EXPERIMENTS
Number of independent experiments: 2.
METHOD OF APPLICATION:
* Direct plate incorporation method: for preliminary test and first experiment
* Preincubation: for the second experiment
DURATION
- Preincubation period: 60 min
- Exposure duration: 48-72H
NUMBER OF REPLICATIONS: triplicates
CONTROLS
* Without S9 mix
- Sodium azide (NAN3): 1 µg/plate for TA 1535; TA 100 strains
- 9-Aminoacridine (9AA): 50 µg/plate for TA 1537 strain
- 2-Nitrofluorene (2NF): 0.5 µg/plate for TA 98 strain
- Mitomycin C (MMC): 0.5 µg/plate for TA 102 strain
* With S9 mix:
- 2-Anthramine (2AM): 2 µg/plate for TA 1535; TA 1537; TA 98; TA 100 strain and 2AM: 10 µg/plate for TA 102 strain - Evaluation criteria:
- Reproducible increase in the number of revertant colonies (2-fold for TA98/TA100 and TA102, 3-fold for TA 1535/TA 1537) compared with vehicle controls in any strain at any dose-level and/or evidence of a dose-relationship.
Reference to historical data and consideration to biological relevance may also be taken into account.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING STUDY:
- Results on solubility: The test substance was freely soluble in the vehicle at 50 mg/ml. Consequently, with a maximum dose volume of 100 µl/plate, the dose-levels for the preliminary toxicity test were: 10, 100, 500, 1000, 2500 and 5000 µg/plate.
- Results on cytotoxicity: A slight to strong emulsion was observed in the Petri plates when scoring the revertants at dose
levels 2500 µg/plate. Without S9 mix, a slight toxicity was noted towards the TA 98 and TA 102 strains at dose-Ievels of 500 µg/plate and 1000 pg/plate, respectively. In the TA 100 strain, a slight to moderate toxicity was induced at dose-levels 100 µg/plate. With S9 mix, the test substance was totally toxic at dose-levels of 5000 µg/plate (TA 100 and TA 102 strains) or 2500 pg/plate (TA 98 strain). In addition in the TA 98 strain, a slight thinning of the bacterial lawn was noted at 1000 µg/plate. In the TA 102 strain, with S9 mix, a 2.6-4.7 fold increase in the number of revertants was noted at dose-levels of between 500 and 2500 µg/plate.
Mutagenicity results are presented in tables 1 to 4. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results: see attached doc
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Tert-amyl peroxy-2-ethylhexanoate shown mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium. - Executive summary:
The potential of the test item Tert-amyl peroxy-2-ethylhexanoateto induce reverse mutation in Salmonella typhimurium (strains: TA 1535, TA 1537, TA 98, TA 100 and TA 102) was evaluated in accordance with the international guidelines (OECD 471, Commission Directive No. B13/14) in compliance with the Principles of Good Laboratory Practice.
The test item was tested in two independent experiments, with and without a metabolic activation system.
Both experiments were performed according to the direct plate incorporation method except the second with S9 mix, which was performed according to the preincubation method (60 minutes, 37°C).
Bacterias were exposed to the test item at six dose-levels (three plates/dose-level) selected from a preliminary toxicity test. After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The test item did not induce any noteworthy increase in the number of revertants, both with and without S9 mix in TA98, 100, 1537 and 1538. The test item induced a mutagenic activity in TA 102 but only with S9.
Tert-amyl peroxy-2-ethylhexanoate shown mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium in TA 102 with S9.
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