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EC number: 252-029-5 | CAS number: 34443-12-4
- 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 Acute oral toxicity of TBEC was evaluated in rats according to OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of 5000 mg/kg (Thouin, 1985). Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14). There was no mortality. Excepted diarrhea among most animals in the beginning of the study, no systemic toxicity was reported Body weight gain was normal. Macroscopic examination at necropsy revealed no gross abnormalities. Under these experimental conditions, the oral LD0 of TBEC was higher than 5000 mg/kg in Sprague Dawley rats.
TBEC evaluated for acute oral toxicity in male and female white Sprague-Dawley rats in a limit test similar to OECD 401 guideline (Reagan, 1985a). TBEC was administered by gavage to each of ten Sprague-Dawley rats (5 male, 5 female) at a level of 5.0 g/kg body weight. All animals survived the 15 day post-treatment observation period. Based on this result, the acute oral LD0 of TBEC was higher than 5.0 g/kg body weight.
Acute dermal toxicity
TBEC was evaluated for acute dermal toxicity in male and female white rabbits in a limit test similar to OECD 402 guideline (Reagan, 1985b). TBEC was applied to each of ten rabbits at a level of 2.0 g/kg body weight. There was noteworthy findings at necropsy. All animals survived the 15 day post-application observation period. Based on this result, the acute dermal LD0 of TBEC was higher than 2.0 g/kg body weight.
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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- 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:
- TEST ANIMALS
- Source: Iffa Credo, Brussel, Belgium
- Young animals
- Weight at study initiation: 281.9 +-7 (male)/ 208.8+-8 (female)
- Fasting period before study: 12 hours before, and 4 hours after gavage
- Housing: individually in Macrolon cages
- Diet and water ad libitum
- Acclimation period: 6 days
- Quarantine period of 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 25-70
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- 5.405 mL/Kg
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Preliminary study:
- Dose range finding study with one male and one female, at following doses: 1800, 2400, 3200, 4200, 5000 mg/kg : no mortality, no clinical signs excepted diarrhea, no gross abnormalities at necropsy.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no
- Clinical signs:
- other: diarrhea for 9 animals the two first days
- Gross pathology:
- no effect
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD0 of TBEC more than 5000 mg/kg in Sprague Dawley rats.
- Executive summary:
The Acute oral toxicity of TBEC was evaluated in rats according to OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of 5000 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14).
There was no mortality. Excepted diarrhea among most animals in the beginning of the study, no systemic toxicity was reported Body weight gain was normal. Macroscopic examination at necropsy revealed no gross abnormalities.
Under these experimental conditions, the oral LD0 of TBEC was higher than 5000 mg/kg in Sprague Dawley rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, comparable to OECD 401 guideline. Raw data available. Nevertheless there is few data on the substance and no CoA.
- 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:
- - Young adult Sprague Dawley rats were obtained from Charles River Breeding Laboratories, Inc., Wilmington, MA
- Animals were individually housed in wire mesh bottom cages in an environment-controlled room and were offered food and water ad libitum.
- After an acclimation period of at least 5 days, animals were assigned to the test.
- Animals were fasted overnight prior to receiving the dose - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 5.0 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- All animals were observed frequently on the day of dosing and twice daily for the remainder of the study.
All external signs of toxicity or pharmacological effects were noted.
Body weights were recorded initially, on days 8 and 15 or at death.
All animals that died during the study and those sacrificed at termination (day 15) were subjected to a gross necropsy and abnormalities were noted. - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: Ataxia: 0/5 male 2/5 female Decreased activity: 2/5 male 1/5 female Diarrhea: 4/5 male 4/5 female Wet abdomen: 0/5 male 2/5 female
- Gross pathology:
- No noteworthy findings
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions, t-Butyl-2-Ethylhexyl-monoperoxycarbonate did not cause mortality in an acute oral toxicity test at 5.0 g/kg.
- Executive summary:
t-Butyl-2 -Ethylhexyl-monoperoxycarbonate was evaluated for acute oral toxicity in male and female white Sprague-Dawley rats in a limit test similar to OECD 401 guideline.
The test article was administered by gavage to each of ten Sprague-Dawley rats (5 male, 5 female) at a level of 5.0 g/kg body weight. All animals survived the 15 day post-treatment observation period. Based on this result, the acute oral LD0 of the test article is considered to be greater than 5.0 g/kg body weight.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Klimisch 1, GLP compliant.
Acute toxicity: via inhalation route
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:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, comparable to OECD 402 guideline. Raw data available. Nevertheless there is few data on the substance.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- 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:
- TEST ANIMALS
- Source: LaCrosse Industries, Inc., Schenectady, New York
- Age at study initiation: no data (young adults)
- Weight at study initiation: no data
- Housing: The rabbits were individually housed in wire mesh bottom cages in environment-controlled rooms and provided NIH 09 Rabbit Ration (Zeigler Brothers, Gardners, PA) and had water ad libitum
- Acclimation period: minimum of 5 days - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test article was administered to intact skin under an occlusive binder at a level of 2.0 g/kg body weight. The binder consisted of a layer of plastic wrap and stockinette sleeve all securely held in place with mask ing tape.
- Duration of exposure:
- 24 hours
- Doses:
- 2 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- After an exposure period of 24 hours, the binders were removed. The exposure sites were gently wiped with clean gauze to remove
as much non-absorbed test article as possible.
All animals were observed frequently on the day of dosing and twice daily thereafter for the remainder of the study.
All external signs of toxicity or pharmacological effects were noted. Necropsy was performed on all animals
Body weights were recorded initially, on days 8 and 15 or at death. - Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: Anorexia : 1/5 male and 0/5 female Diarrhea 1/5 male and 1/5 female Nasal discharge: 1/5 male and 0/5 female Soft stools: 1/5 male and 1/5 female
- Other findings:
- No noteworthy findings at necropsy
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, t-Butyl-2-Ethylhexyl-monoperoxycarbonate did not cause mortality in an acute dermal toxicity test at 2 g/kg.
- Executive summary:
t-Butyl-2-Ethylhexyl-monoperoxycarbonate was evaluated for acute dermal toxicity in male and female white rabbits in a limit test similar to OECD 402 guideline. The test article was applied to each of ten rabbits at a level of 2.0 g/kg body weight.
There was noteworthy findings at necropsy. All animals survived the 15 day post-application observation period. Based on this result, the acute dermal LD50 of the test article is considered to be greater than 2.0 g/kg body weight.
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, GLP compliant.
Additional information
Justification for classification or non-classification
According to EU Regulation (EC) N0. 1272/2008 (CLP), TBEC is not classified for acute toxicity (oral, dermal and inhalation).
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