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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 257-077-0 | CAS number: 51240-95-0
- 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
Description of key information
Oral 28-day (OEC407) and 90-day (OECD 408) repeated dose toxicity studies are available.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- K1: The study was performed according to OECD guidelines and GLP.
- System:
- male reproductive system
- Organ:
- other: sperm
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The oral administration of 1,1,3,3-Tetramethylbutyl peroxyneodecanoate (CAS Number: 51240-95-0) to rats for twenty-eight days at dose levels up to 1000 mg/kg bw/day resulted in treatment-related findings in both sexes at 30, 300 and 1000 mg/kg bw/day. The findings noted in females of the high dose group were considered minimal and therefore 1000 mg/kg bw/day may be considered a NOAEL for females. Similar findings were noted in males at the high dose but, in addition, microscopic kidney findings were noted in all treatment groups which were characterised by hyaline droplets, increased tubular degeneration/regeneration and granular casts and at 1000 mg/kg bw/day by interstitial inflammatory infiltrates. These findings were consistent with alpha-2u-globulin nephropathy, consistent with well documented findings peculiar to the male rat in response to treatment with some hydrocarbons, and with no human relevance. Excluding these kidney findings the NOAEL for males was considered to be 300 mg/kg bw/day based on findings on haemoglobin, erythrocyte count and haematocrit at 1000 mg/kg bw/day, the aetiology of which was uncertain.
In the 90-day study, the oral gavage administration of 1,1,3,3-tetramethylbutyl peroxyneodecanoate (CAS# 51240-95-0) to male and female Wistar Han™:RccHan™:WIST strain rats at 10, 100 or 300 mg/kg bw/day resulted in toxicologically significantly lower sperm concentration and motility with an associated higher number of sperm abnormalities at the high dose. Such findings were still noted in males previously treated with 300 mg/kg bw/day after a 28-day treatment-free period. Although group mean sperm concentration and motility were lower at 100 mg/kg bw/day compared to controls, in the absence of associated sperm morphological and histopathological findings this observation was considered of low toxicological significance if at all. A dose level of 100 mg/kg bw/day was established as NOAEL for systemic toxicity in the male rat. In contrast, there were no findings of toxicological significance in the females up to a dose level of 300 mg/kg bw/day which could therefore be established as a NOAEL in the female rat.
Justification for classification or non-classification
The oral (gavage) administration of 1,1,3,3-tetramethylbutyl peroxyneodecanoate (CAS# 51240-95-0) to male and female Wistar Han™:RccHan™:WIST strain rats at a dose level of 300 mg/kg bw/day for 90 days resulted in toxicologically significantly lower sperm concentration and motility with an associated increase in sperm abnormalities. Such findings were still noted in males previously treated with 300 mg/kg bw/day after a 28-day treatment-free period. The dose level of 100 mg/kg bw/day was therefore established as NOAEL for systemic toxicity in the male rat. As there were no changes of toxicological significance in females up to a dose level of 300 mg/kg bw/day, the dose level of 300 mg/kg bw/day was established as NOAEL in the female rat.
Based on the results from the 90-day oral toxicity study in rats the substance is classified as a Category 1B Reproductive Toxicant (H360F; see also 7.8.1).
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.