Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-128-1 | CAS number: 78-63-7
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2003-12-22 to 2004-02-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD 203 and under GLP but no analytical measurment were performed and the report is not well documented (preliminary study of a Bioaccumulation test performed by NITE 2004).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992 version
- Deviations:
- yes
- Remarks:
- major: the concentation of the test substance in the test solution was not measured and the result LC50 was calculated based on the nominal concentration.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):K-1385
- Molecular formula (if other than submission substance): C16H34O4
- Molecular weight (if other than submission substance): 290.44 g/mol
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: Pale yellow liquid
- Physical state: Liquid
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: not applicable
- Purity test date: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: Measurements were made of the infrared absorption spectrum of the obtained test substance, and confirmation was made of the structure of the subject test substance. Furthermore, measurements were made of a mass spectrum and the Nuclear Magnetic Resonance Spectrum, and the structure was confirmed. Even after the performance of testing, measurements were taken of the infrared absorption spectrum, and comparison was made with the spectrum measured prior to the commencement of testing. As a result, the stability of the test substance was confirmed by the fact that there was no change the spectrum.
- Storage condition of test material: The test substance was stored in a test substance storage refrigerator, in the Research Institute.
- Supplier: Chemical Substance Evaluation Research Institute Co., LTD.
- Date received: June 20, 2003
- Analytical purity: 95 % (GC)
- Lot/batch No.: 11213J0 - Analytical monitoring:
- no
- Details on sampling:
- - Concentrations: 0, 1, 2, 4, and 8 mg/L
- Sampling method: The sampling method is described in Fig.2
- Sample storage conditions before analysis: not applicable - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solution was prepared by first obtaining 460 µL of the test substance to mix with 8 g of HCO-40 and then bringing the final volume to 20 mL with 2-methoxyethyl alcohol. Then, 0.25, 0.5, 1, 2 mL of the solution was individually added to 5 L of the dilution water.
- Differential loading:
+ test substance concentration: 1, 2, 4, 8 mg/L
+ HCO-40 concentration: 20, 40, 80, 160 mg/L
+ 2-methoxy alcohol concentration: 240 ppm (v/v)
- Controls: The test solution was prepared by first obtaining 8 g of HCO-40 to add in 2-methoxy alcohol to bring the final volume to 20 mL. Then, 2 mL of the solution was added to the 5 L of the dilution water.
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): < 0.04% of 2-methoxyethyl alcohol.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no data - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Medaka
- Source: Amijima Fisheries (Kanagawa Ken, Yokohama Shi, Minato Kita Ku Amijima Nishi 5-18-1.).
- Lot number: 03-H-0714
- Acquisition date: July 14, 2003
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): 2 +/- 1 cm
- Weight at study initiation (mean and range, SD): ca. 0.2 g
- Method of breeding: no data
- Feeding during test: yes
- Food type: no data
- Amount: no data
- Frequency: no data
ACCLIMATION
- Acclimation period: at least 2 weeks
- Acclimation conditions (same as test or not): same as test. Yes
- Type and amount of food: TetraMin (Tetra Werke), equivalent to 2% of fish bodyweight
- Feeding frequency: daily but no feed for 24h prior to the test
- Health during acclimation (any mortality observed): At the time of commencing purification, visual obsertankion is made, abnormal specimens are removed, and the fish are raised in flowing water. During purification, there is no addition of a medicated solution. No chemical treatment during the habituation period was conducted. Death rate less than 5% . - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no data
- Hardness:
- no data
- Test temperature:
- 24 +/- 1°C
- pH:
- no data
- Dissolved oxygen:
- At least 60% of saturated-dissolved oxygen concentration
- Salinity:
- not applicable
- Nominal and measured concentrations:
- Nominal concentrations: 0, 1, 2, 4, and 8 mg/L
- Details on test conditions:
- TEST SYSTEM
- Material, size, headspace, fill volume: Sealed conditions, 5 Litres
- Aeration: Bubbling oxygen
- Renewal rate of test solution (frequency/flow rate): water replacement every 24h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- No. of vessels per vehicle control (replicates):0
- Biomass loading rate: no data
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: no data
OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: no data
- Light intensity: no data
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 4.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- no data available on the individual effect per test concentration
- Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- no data
- Validity criteria fulfilled:
- yes
- Conclusions:
- The results demonstrated a LC50(96h) = 4.5 mg/L of 2,5 dimethyl-2,5-di (tert-butyl peroxy) hexane on the fish Medaka (Oryzias latipes, Medaka). This value is greater than the limit of solubiltiy of the test substance.
- Executive summary:
Acute toxicity of 2,5 dimethyl-2,5-di (tert-butyl peroxin) hexane named K-1385 was tested on the fish type medaka, Oryzias latipes, following OECD guideline 203 and under GLP. However, no analytical measurments were performed and the report is poorly documented because the test was a preliminary study for a bioaccumulation test.
Seven fish per concentration were exposed to 0, 1, 4, and 8 mg/L nominal concentrations under semi-static conditions for 96 h. The test solutions were prepared by first obtaining 460 µL of the test substance to mix with 8 g of HCO-40 and then bringing the final volume to 20 mL with 2-methoxyethyl alcohol. Then, 0.25, 0.5, 1, 2 mL of the solution was individually added to 5 L of the dilution water. The test conditions were 24 +/-°C and at least 60% of saturated-dissolved oxygen concentration. The 96hr-LC50 determined at 4.5 mg/L was calculated by Dodoroff method (Probit analysis). While no concentration related data are available, it can be concluded that the observed toxicity is significantly higher than the water solubility of the test substance (measured as part of the same NITE study (2004) in a shake flask test as 0.014 mg/L.
Reference
Description of key information
Based exclusively on one study in medaka, acute toxicity of 2,5 dimethyl-2,5-di (tert-butyl peroxin) hexane named K-1385 was tested on the fish type medaka, Oryzias latipes, following OECD guideline 203 and under GLP. The 96hr-LC50 determined at 4.5 mg/L was calculated by Dodoroff method (Probit analysis). This value greatly exceeds the limit of solubility (determined in a shake flask method as 0.014 mg/L).
Key value for chemical safety assessment
Additional information
Based on one study in medaka, acute toxicity of 2,5 dimethyl-2,5-di (tert-butyl peroxy) hexane named K-1385 was tested on the fish type medaka, Oryzias latipes, following OECD guideline 203 and under GLP. Seven fish per concentration were exposed to 0, 1, 4, and 8 mg/L nominal concentrations under semi-static conditions for 96 h. The test solutions were prepared by first obtaining 460 µL of the test substance to mix with 8 g of HCO-40 and then bringing the final volume to 20 mL with 2-methoxyethyl alcohol. Then, 0.25, 0.5, 1, 2 mL of the solution was individually added to 5 L of the dilution water. The test conditions were 24 +/-°C and at least 60% of saturated-dissolved oxygen concentration. The 96hr-LC50 determined at 4.5 mg/L was calculated by Dodoroff method (Probit analysis). This value greatly exceeds the limit of solubility of the test substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.