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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No effects on reproductive organs were found in the 90-day OECD 408 study summarized elsewhere in this dossier. In addition, there were no developmental effects reported in an OECD TG 414 study.These results suggest a low risk for reproductive toxicity; therefore, we are waiving the requirement for a reproductive toxicity study.
Justification for selection of Effect on fertility via oral route:
A reproduction study is scientifically unjustified based on the lack of adverse findings on reproductive organs in a 90-day repeat dose study as well as in a developmental study.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- No effects on reproductive organs were found in the 90-day OECD TG 408 study summarized elsewhere in this dossier. In addition, there were no developmental effects reported in an OECD TG 414 study. These results suggest a low risk for reproductive toxicity; therefore, we are waiving the requirement for a reproductive toxicity study.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
No adverse developmental findings were reported in an OECD 414 study when tested up to 300 mg/kg/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Treatment of pregnant females with Di-Tert-Butyl 1,1,4,4-Tetramethyl Tetramethylene Diperoxide (CAS# 78-63-7) at dosages of up to 300 mg/kg bw/day was not associated with any obvious treatment-related effects on clinical signs, body weight performance or food consumption. As anticipated, necropsy revealed an increased in absolute and body weight relative liver weights but there were no obvious macroscopic abnormalities apparent. Increased liver weights were also apparent for both sexes at 150 mg/kg bw/day in a Ninety Day Toxicity Study in the Rat (Harlan Laboratories Ltd Study Number 41301877) with this test item; this finding was not accompanied by any evidence of microscopic change and was considered to be adaptive in nature. The increased liver weights at 300 mg/kg bw/day are considered most likely to reflect the same adaptive process and, as such, are considered not to represent an adverse effect of treatment. A dosage of 300 mg/kg bw/day is therefore considered to represent the No Observed Adverse Effect Level (NOAEL) for the pregnant females with the No Observed Effect Level (NOEL) being 60 mg/kg bw/day. The No Observed Effect Level (NOEL) for the in-utero survival, growth and development of the offspring was considered to be 300 mg/kg bw/day.
Justification for selection of Effect on developmental toxicity: via oral route:
Apparently well conducted study GLP.
Justification for classification or non-classification
There were no adverse effects, on reproductive organs, in a 90-day repeat dose study and no adverse developmental effects reported in an OECD 414 study.
Additional information
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.
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