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EC number: 221-111-2 | CAS number: 3006-86-8
- 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
In an acute oral toxicity study with cyclohexylidenebis[tert-butyl] peroxide in rats a LD50 value of 16653 mg/kg bw with a confidence interval of 11912 to 23279 mg/kg bw was determined. No acute inhalation study is available. In an acute dermal toxicity study with cyclohexylidenebis[tert-butyl] peroxide in rabbits a LD50 value of > 2000 mg/kg bw was determined.
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:
- 1978-07-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries, Inc., Indianapolis, Indiana, USA
- Weight at study initiation: 200 - 253 g
- Fasting period before study: rats were fasted overnight before dosing (ca. 18 h)
- Housing: 5 animals/sex/cage; hanging wire-mesh cages
- Diet: Purina laboratory Chow, ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
Temperature and humidity controlled quarters were used for housing. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mL/kg bw (6810, 8260 mg/kg bw), 20 mL/kg bw (10000, 12100, 14700, 17800 mg/kg bw), 30 mL/kg bw (21500 mg/kg bw)
MAXIMUM DOSE VOLUME APPLIED: 30 mL/kg bw - Doses:
- 6810, 8260, 10000, 12100, 14700, 17800, 21500 mg/kg bw
- No. of animals per sex per dose:
- five rats/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 hours following dosing at 24 hours and daily thereafter for 14 days
- Necropsy of survivors performed: no
- Other examinations performed: body weight: recorded prior to dosing and at days 7 and 14 - Statistics:
- Statistics were performed using Thompson and Weil (1952).
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 13 342 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 10 895 - 16 338
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 21 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 16 653 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 11 912 - 23 279
- Mortality:
- No deaths occurred in dosing group 6.810 mg/kg bw. In dose group 8.260 mg/kg bw one animal died (female). 10.000 and 12.100 mg/kg bw caused a death to two out of ten animals (one male and female). In dosing group 14.700 mg/kg bw six rats died (two males, four females). The two highest dosing groups 17.800 mg/kg bw and 21.500 mg/kg bw caused the death of five animals each (one male, 4 females; two males, three females).
- Clinical signs:
- other: NA
- Body weight:
- lower than 10% body weight loss
- Remarks:
- All surviving rats gained weight during the study.
- Gross pathology:
- NA
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity study on Sprague-Dawley rats treated with 1,1-bis(tert-butylperoxy)cyclohexane resulted in a LD50 of above 2000 mg/kg bw for male and female rats.
- Executive summary:
The acute oral toxicity of 1,1-Di(t-butyl peroxy) cyclohexane was evaluated in Sprague-Dawley rats. The test material was administered orally by gavage as a solution in com oil at the following dosage levels to male and female rats: 6810, 8260, 10000, 12100, 14700, 17800 and 21500 mg/kg.The rats were observed for mortality, only, during the first four hours following dosing, at 24 hours and daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing (control weight) and at 7 and 14 days. All surviving rats gained weight during the study. The LD50 value for male and female animals was determined to be 16653 mg/kg bw with a 95 % confidence interval of 11912 to 23279 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 16 653 mg/kg bw
- Quality of whole database:
- The study is considered reliable with restrictions and equivalent to OECD 401.
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:
- Justification for type of information:
- Testing for acute toxicity via the inhalation route was not applicable as data on acute oral and acute dermal toxicity are available. According to the REACH Regulation No. 1907/2006, Annex VIII, 8.5.1 only information on two application routes needs to be provided, with test item administration via the most appropriate route. Additionally, the vapour pressure of the test item is low (92 Pa at 58°C) and exposure via inhalation route is not expected.
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:
- 2004-2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24th February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 31st July 1992
- Deviations:
- no
- 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/Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 321 +/- 10 g for the males and 211 +/- 4 g for the females
- Fasting period before study: no data
- Housing: individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm)
- Diet: free access to adapted pelleted diet
- Water: Drinking water filtered by a FG Millipore membrane (0.2 micron) was provided ad libitium.
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 22+/- 2 °C
- Humidity: 30 to 70 %
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 h light/12 h dark - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 cm x 7 cm for males and 5 cm x 6 cm for the females
- Type of wrap if used: an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage
TEST MATERIAL
- Amount(s) applied: 2.41 mL/kg
- Constant volume or concentration used: yes - Duration of exposure:
- single
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day 15. Type, time of onset and duration of clinical signs were recorded for each animal individually. From day 2, any local cutaneous reaction was recorded.
The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinical signs and no cutaneous reactions were observed during the study.
- Body weight:
- lower than 10% body weight loss
- Remarks:
- A slightly reduced body weight gain was seen in 2/5 females during the second week of the study.
- Gross pathology:
- Macroscopic examination of main organs of the animals revealed no apparent abnormalities.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD0 of the test item cyclohexylidenebis[tert-butyl] peroxide is higher than or equal to 2000 mg/kg in rats.
- Executive summary:
The acute dermal toxicity of the test item cyclohexylidenebis[tert-butyl] peroxide was evaluated in rats according to OECD guideline No. 402 and EU method B.3. The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females).
The application was performed with diluted test item at the dose-level of 2000 mg/kg, taking into consideration that its specific gravity was 0.83 g/mL. The test site was then covered by a semi-occlusive dressing for 24 hours.
Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item. All animals were subjected to necropsy.
No clinical signs, no cutaneous reactions and no deaths were observed during the study. A slightly reduced body weight gain was seen in 2/5 females during the second week of the study. The overall body weight gain of the other animals was similar to that of CIT historical control animals. No apparent abnormalities were observed at necropsy in any animal.
The dermal LD0 of the test item cyclohexylidenebis[tert-butyl] peroxide is higher than or equal to 2000 mg/kg in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study according to OECD/EU guideline. The study is considered as reliable without restrictions.
Additional information
Acute toxicity: oral
The acute oral toxicity of 1,1-Di(t-butyl peroxy) cyclohexane was evaluated in Sprague-Dawley rats. The test material was administered orally by gavage as a solution in com oil at the following dosage levels to male and female rats: 6810, 8260, 10000, 12100, 14700, 17800 and 21500 mg/kg.The rats were observed for mortality, only, during the first four hours following dosing, at 24 hours and daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing (control weight) and at 7 and 14 days. All surviving rats gained weight during the study. The LD50 value for male and female animals was determined to be 16653 mg/kg bw with a 95 % confidence interval of 11912 to 23279 mg/kg bw.
Acute toxicty: inhalation
Additional testing by inhalation route is not applicable as data for oral and dermal toxicity study were available. According to the REACH Regulation No. 1907/2006, Annex VIII, 8.5.1 only information on two application routes needs to be provided, with test item administration via the most appropriate route. Additionally, the vapour pressure of the test item is low (92 Pa at 58°C) and exposure via inhalation route is not expected.
Acute toxicity: dermal
The acute dermal toxicity of the test item cyclohexylidenebis[tert-butyl] peroxide was evaluated in Sprague-Dawley rats (males and females) according to OECD guideline No. 402 and EU method B.3. Diluted test item at the dose-level of 2000 mg/kg was applied (specific gravity: 0.83 g/mL). Semi-occlusive dressing for 24 hours. No clinical signs, no cutaneous reactions and no deaths were observed during the study. A slightly reduced body weight gain was seen in 2/5 females during the second week of the study. Overall body weight gain was similar to that of historical control animals. Thus, the dermal LD0 of the test item cyclohexylidenebis[tert-butyl] peroxide is higher than or equal to 2000 mg/kg in rats.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item does not require classification according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692. The substance contains up to 25 % isododecane as stabilizer which is classified as aspiration toxicity cat. 1. Based on the kinematic viscosity of the substance and in accordance with the section 3.10.3 of Annex I of Regulation (EC) No 1272/2008 (CLP) the substance has to be classified as aspiration toxicity cat. 1, H304: May be fatal if swallowed and enters airways.
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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