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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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: the oral LD0 of tert-amyl peroxyoctoate is more than 5000 mg/kg in Sprague Dawley rats (Reagan, 1981)
Acute dermal toxicity: the dermal LD0 of tert-amyl peroxyoctoate is more than 2000 mg/kg in New-Zealand White rabbits (Reagan, 1981)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2a Guideline study without detailed documentations (no certificat of analysis for example)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Sprague Dawley rats, 200-300 g at arrival
- Acllimation periode: 5 days
- Housing: individually
- Fasting overnight - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - All animals were weighted prior to exposure, and at termination.
- Animals were observed daily for 15 days, all gross visible and pharmacological effects were reported.
- No necropsy was performed since no animal died - Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: All the animals exhibited decreased activity the two or three first days after treatment. Some of them had for one or two days wet, yellow belly
- Gross pathology:
- Not observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD0 of tert-amyl peroxyoctotate in rats is more than 5000 mg/kg.
- Executive summary:
The acute oral toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in rats according to a procedure similar to OECD N°401 guideline (Acute Toxic Standard Method) and in compliance with GLP. 10 male and 10 female Sprague Dawley rats were given a single oral dose (5000 mg/kg) of tert-amyl peroxyoctoate. Following treatment, rats were observed daily and weighted at termination. No gross necropsy examination was performed since no mortality occured and since clinical signs (especially decreased activity) were observed only the first days after dosing.
Under these experimental conditions, the oral LD0 of tert-butyl peroxyoctoate is more than 5000 mg/kg in Sprague Dawley rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Klimisch 2 study, GLP compliant.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2a Guideline study without detailed documentations (no certificat of analysis for example)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Acllimation periode: 5 days
- Housing: individually- Food and water ad libidum
- Identification:ear tags and cage cards
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- - The back of the animals were clipped free of furw ith electrical clipper on about 30 % of the body surface.
- On the day of the exposure, abrasion of the exposure site was performed for 3 males and 2 females. The abrasions were minor incisions that were not sufficient deep to disturb the derma or induce a bleeding - Duration of exposure:
- 24 hours, then the exposure site was gently weaped with clean gauze
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Observations for mortality, clinical signs, local reactions, and toxicological findings were recorded for a total of 14 days.
Body weight were recorded on the inital day of dosing, at day 8, and at study termination - Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: Diarrhea, digestivetroubles, several days after dosing, for some animals.
- Gross pathology:
- Not performed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD0 of tert-butyl peroxyoctoate is more than 2000 mg/kg in New Zealand White rabbits.
- Executive summary:
The acute oral toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in rats according to a procedure similar to OECD N°402 guideline (Acute Toxic Standard Method) and in compliance with GLP. 5 male and 5 female New Zealand rabbits were given a single dermal dose (2000 mg/kg) of tert-amyl peroxyoctoate. Following treatment, rabbits were observed daily and weighted at termination. No gross necropsy examination was performed since no mortality occured and since few clinical signs were observed (especially digestive troubles).
Under these experimental conditions, the oral LD0 of tert-butyl peroxyoctoate is more than 2000 mg/kg in New Zealand White rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 2 study, GLP compliant.
Additional information
Acute oral toxicity:
The acute oral toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in Sprague Dawley rats according to a procedure similar to OECD N°401 guideline (Acute Toxic Standard Method) and in compliance with GLP (Reagan, 1981). The oral LD0 was more than 5000 mg/kg. Clinical signs included decreased activity during the first days following exposure. No gross necropsy examination was performed.
Acute dermal toxicity:
The acute dermal toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in New Zealand White rabbits according to a procedure similar to OECD N°402 guideline (Acute Toxic Standard Method) GLP compliant (Reagan, 1981). The dermal LD0 of tert-butyl peroxyoctoate was more than 2000 mg/kg. The main clinical signs were reported in some animals several days after dosing, and consisted in digestive troubles. No gross necropsy examination was performed.
Justification for selection of acute toxicity – oral endpoint
Key study, Klimisch 2.
Justification for selection of acute toxicity – dermal endpoint
Key study, Klimisch 2.
Justification for classification or non-classification
According to EU directive 67/548/EEC and according to EU Regulation (EC) N0. 1272/2008 (CLP), the substance is not classified for acute toxicity.
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