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EC number: 279-349-8 | CAS number: 79916-07-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- Combined repeated dose repro-devp. Screen
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- combined repeated-dose/reproductive/developmental toxicity screening test for Di-tert-butyl Peroxide
- Author:
- SIDS INITIAL ASSESSMENT PROFILE
- Year:
- 2 012
- Bibliographic source:
- combined repeated-dose/reproductive/developmental toxicity screening test for Di-tert-butyl Peroxide OECD SIDS COCAM 3 16-18 October 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- To evaluate the oral repeated dose toxicity of Di-tert-butyl Peroxide in rats by Combined repeated dose repro-devp. Screening test.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Di-tert-butyl peroxide
- EC Number:
- 203-733-6
- EC Name:
- Di-tert-butyl peroxide
- Cas Number:
- 110-05-4
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2,2'-dioxybis(2-methylpropane)
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): bis(1,1-dimethylethyl)peroxide
- IUPAC name: 2,2'-dioxybis(2-methylpropane)
- Molecular formula (if other than submission substance): C8H18O2
- Molecular weight (if other than submission substance): 146.2282
- Smiles notation (if other than submission substance): C(OOC(C)(C)C)(C)(C)C
- InChl (if other than submission substance): 1S/C8H18O2/c1-7(2,3)9-10-8(4,5)6/h1-6H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): bis(1,1-dimethylethyl)peroxide
- IUPAC name: 2,2'-dioxybis(2-methylpropane)
- Molecular formula (if other than submission substance): C8H18O2
- Molecular weight (if other than submission substance): 146.2282
- Smiles notation (if other than submission substance): C(OOC(C)(C)C)(C)(C)C
- InChl (if other than submission substance): 1S/C8H18O2/c1-7(2,3)9-10-8(4,5)6/h1-6H3
- Substance type: Organic
- Physical state: Liquid
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- not specified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- >42 days for female
42 days Male - Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0, 100, 300 or 1000 mg/kg-bw/day
- No. of animals per sex per dose:
- Total no of animals 80
0 mg/kg/day -10 male and 10 female
100 mg/kg/day-10 male and 10 female
300 mg/kg/day-10 male and 10 female
1000 mg/kg/day -10 male and 10 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
Not specified.
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Not specified
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Not specified
CLINICAL CHEMISTRY: Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Not specified.
- Statistics:
- Not specified.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Increased relative weights; minimal centrilobular and diffuse hepatocellular hypertrophy in liver; moderate diffuse tubular degeneration/regeneration with slight multifocal single cell necrosis and hyaline casts as well as hyaline droplets in kidneys of males was observed at 1000 mg/kg bw/day in treated animal compare to control.
At 300 mg/kg bw/day increased relative liver and kidney weights were observed in treated males and females rats compare to control. - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 100 mg/kg/day in male and female rats for Di-tert-butyl Peroxide(110-05-4) by Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test.
- Executive summary:
Repeated dose toxicity study was assessed for Di-tert-butyl Peroxide for its possible repeated dose toxicity effect. For this purpose Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test was performed according to OECD Guideline 422.The test material was exposed to the male and female rats by oral gavage for subchronic period. The test material was used at the concentration of0, 100, 300 or 1000 mg/kg/day.
Increased relative weights; minimal centrilobular and diffuse hepatocellular hypertrophy in liver; moderate diffuse tubular degeneration/regeneration with slight multifocal single cell necrosis and hyaline casts as well as hyaline droplets in kidneys of males was observed at 1000 mg/kg bw/day in treated animal compare to control.
At 300 mg/kg bw/day increased relative liver and kidney weights were observed in treated males and females rats compare to control.
Therefore NOAEL was considered to be 100 mg/kg/day in male and female rats for Di-tert-butyl Peroxide by Oral gavage for sub chronic study.
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