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EC number: 222-389-8 | CAS number: 3457-61-2
- 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
Skin irritation:
The acute dermal irritation of Peroximon 801 (96.8% tert-butyl cumyl peroxide) was evaluated in rabbits according to a GLP OECD 404 guideline (Manciaux, 1999b). The substance was applied undiluted to the skin of one New-Zealand White albino rabbit and held in contact for 3 minutes or 4 hours by means of a semi-occlusive dressing. As no irritation was observed after the 3 -minute exposure, the substance was applied to two other animals for 4 hours. Mean scores over 24, 48 and 72 hours for each animal were evaluated for erythema and for oedema. Animals were then observed daily until day 15. After a 4-hour exposure, no cutaneous reactions were observed in one animal. In the two other animals, a very slight or well-defined erythema was noted between days 1 and 6 and a slight oedema was recorded on days 2, 3 and 4. Dryness of the skin was observed in these animals from day 5 up to the end of the observation period (day 15). Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 2.0 for erythema and 0.0, 2.0 and 2.0 for oedema.
In conclusion, tert-butyl cumyl peroxide is mildly irritating to rabbit skin.
This conclusion is supported by the results of another study (TNO, 1978a), where the substance was topically applied for 24 hours to rabbit skin.
Eye irritation:
Trigonox T (90 -92% tert-butyl cumyl peroxide) was applied in eyes of 6 rabbits (0.1 mL) in a test conducted according to recognized standards (Draize method) (van Beek, 1978). The animals were observed 24 hours and 48 hours after the instillation. The scores for corneal opacity, iritis, conjunctival redness and chemosis were 0, 0, 0.1 and 0, respectively. Therefore the substance is not irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17th July 1992
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals:
Sex, species, strain: male New Zealand White rabbits.
Reason for this choice: species generally accepted by regulatory authorities for this type of study. Breeder. Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number of animals: three animals were used, as recommended by the international guidelines. Identification: the animals were identified individually with a metal ear tag.
Weight: on the day of treatment, the animals had a mean body weight ± standard deviation of
2.4±0.1 kg.
Acclimatization: at least 5 days before the beginning of the study.
Environmental conditions:
. temperature: 18 ± 3°C
. relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals. The animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
Each cage was equipped with a food container and a water bottle.
Food and water ad libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- The test substance was used undiluted (0.5 ml)
- Duration of treatment / exposure:
- As possible irritant effects were anticipated, the test substance was evaluated in one animal in a first assay. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank. Since the test substance was not strongly irritant in this first assay, it was then applied for
4 hours to two other animals in a second assay. - Observation period:
- - 72 hours when there was no evidence of dermal irritation after 72 hours
- until day 15 when there was persistent cutaneous irritation after 72 hours - Number of animals:
- 3
- Details on study design:
- Doses of 0.5 ml of the test substance were placed on a 6 cm 2 dry gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals. The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 96h
- Irritant / corrosive response data:
- After a 3-minute exposure (one animal): No cutaneous reactions were observed.
After a 4-hour exposure (three animals): No cutaneous reactions were observed in one animal.
In the two other animals, a very slight or well-defined erythema (grade 1 or 2) was noted between days 1 and 6 and a slight oedema (grade 2) was recorded on days 2, 3 and 4.
Dryness of the skin was observed in these animals from day 5 up to the end of the observation period (day 15).
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 2.0 for erythema and
0.0, 2.0 and 2.0 for oedema. All the scores were 2 for animal 2 and 3, at 24, 48 and 72 hours - Other effects:
- Any change in the animal behaviour was noted.
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- t-BUTYL-CUMYL PEROXIDE is mildly irritating when applied topically to rabbits.
- Executive summary:
The acute dermal irritation of Peroximon 801 (96.8 % tert-butyl cumyl peroxide) was evaluated in rabbits according to OECD 404 guideline (GLP study). The substance was applied undiluted to the skin of 1 New-Zealand White albino rabbit and held in contact for 3 minutes or 4 hours by means of a semi-occlusive dressing. As no irritation was observed after the 3-minute exposure, the substance was applied to two other animals for 4 hours. Mean scores over 24, 48 and 72 hours for each animal were evaluated for erythema and for oedema. Animals were then observed daily until day 15. After a 4-hour exposure (three animals): No cutaneous reactions were observed in one animal. In the two other animals, a very slight or well-defined erythema was noted between days 1 and 6 and a slight oedema was recorded on days 2, 3 and 4. Dryness of the skin was observed in these animals from day 5 up to the end of the observation period (day 15). Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 2.0 for erythema and 0.0, 2.0 and 2.0 for oedema.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Draize method
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The anirnals are caged individually and reccive no hay or ether extraneous material that might enter the eyes.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The eye has not been rinsed.
- Observation period (in vivo):
- The eyes were observed 24 hours, 48 hours, 72 hours and 7 days after instillation of the susbtance
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material Scoring with Draize method
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- NOTE: Explanation for the concise "BASIS": Six rabbits were tested. ALL animals gave 0 (zero) scores for corneal opacity, iris, conjunctivae, and chemosis after 24 hours and after 48 hours, EXCEPT animal # 1 that had conjunctiva score of 1 after 24 hours only. Therefore individual scores are not entered for each animal for each parameter, and at each time point.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tert-butyl cumyl peroxide is not irritating to eyes.
- Executive summary:
Trigonox T (90 -92% tert-butyl cumyl peroxide) was applied in eyes of 6 rabbits (0.1 mL) in a test conducted according to recognized standards (Draize method). The animals were observed 24 hours and 48 hours after the instillation. The scores for corneal opacity, iritis, conjunctival redness and chemosis were 0, 0, 0.1 and 0, respectively. Therefore the substance is not irritating to eyes.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The substance is borderline (GHS cat 3) for skin irritation classification. Therefore, the current regulatory classification (cat 2, H315) is not challenged.
According to EU Regulation (EC) N0. 1272/2008 (CLP), the substance (TBCP) is not classified for eye irritation.
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