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EC number: 239-557-1 | CAS number: 15520-11-3
- 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
Di-(4-tert-butylcyclohexyl)peroxydicarbonate is not irritating in primary skin and eye irritation tests according to Draize (1944) and FDA-standards (1963), respectively, when applied at a concentration of 0.5 g to the abraded and the intact skin or of 0.1 g instilled into the eyes of albino rabbits.
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:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific standards, well documented and acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : exposure 24 hours instead of 4 hours; 12 animals were used
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adults - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- observation 24 h and 72 h after exposure
- Number of animals:
- 12
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch x 1 inch
- % coverage: no data
- Type of wrap if used: surgical patch fixed by adhesive tape, wrapped with impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: patch and material are removed after 24 h
SCORING SYSTEM: Draize (1944) and CIVO-grading system
Primary irritation to the skin is measured by a patch-test technique on the abraded and the intact skin of albino rabbits.
Twelve healthy adult New Zealand White albino rabbits were used for the test substance. 24 hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
An amount of 0.5 g of the test substance was brought into contact of the intact and the abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
Six rabbits are treated on the intact skin, the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize (J. Pharmacol. 82 (1944) 377-). A second reading is made 48 hours later (72 hours after application).
In the case of surface active test substances the skin reactions after 72 hours usually consist of scaliness and/or necrosis. Since the Draize grading system does not comprise these abnormalities the second reading is carried out on the basis of the CIVO-grading system. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 h; 72h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no irritation
- Remarks on result:
- other: Intact and abraded skin
- Other effects:
- No other effects
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Bis(4-tert-butylcyclohexyl) peroxydicarbonate did not cause any signs of skin irritation.
- Executive summary:
In a primary dermal irritation study, 12 healthy adult New Zealand White albino rabbits were dermally exposed to 0.5 g of Perkadox 16 (Bis(4-tert-butylcyclohexyl) peroxydicarbonate) to an area of 1 inch² on abraded or intact skin of the back of 6 animals in each case. Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored according the method of Draize et al. 1944 and the CIVO grading system. No reaction at all was observed. In this study Bis(4-tert-butylcyclohexyl) peroxydicarbonate is not a dermal irritant.
Reference
Table 2: Individual and average skin irritation scores of Bis(4-tert-butylcyclohexyl) peroxydicarbonate
Rabbit number |
Intact skin |
|
Abraded skin |
||||||
24 hours |
72 hours |
Rabbit number |
24 hours |
72 hours |
|||||
A |
B |
A |
B |
|
A |
B |
A |
B |
|
5516 |
0 |
0 |
0 |
0 |
5510 |
0 |
0 |
0 |
0 |
5517 |
0 |
0 |
0 |
0 |
5511 |
0 |
0 |
0 |
0 |
5518 |
0 |
0 |
0 |
0 |
5512 |
0 |
0 |
0 |
0 |
5519 |
0 |
0 |
0 |
0 |
5513 |
0 |
0 |
0 |
0 |
5520 |
0 |
0 |
0 |
0 |
5514 |
0 |
0 |
0 |
0 |
5521 |
0 |
0 |
0 |
0 |
5515 |
0 |
0 |
0 |
0 |
average |
0 |
0 |
average |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study with acceptable restriction
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : no clinical observation after 1 h; 6 animals were used
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 28 (119), 5582, 1963 (published by the FDA of the USA) and Draize and Kelley (Drug. Cosmet. Industr. 71 (1952) 36)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individually
- no hay or other extrageneous material that might enter the eye
- examination of the eyes before testing - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Single treatment. The eyes were not washed after treatment. The exposure period is as long as observation period.
- Observation period (in vivo):
- Observation after 24 h, 48h, 72 h and 7 days after exposure.
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: FDA scoring scale (see table 1)
TOOL USED TO ASSESS SCORE: binocular - Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- ca. 0.83
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Bis(4-tert-butylcyclohexyl) peroxydicarbonate causes ocular lesions of slight degree. According the FDA-Standards it is not considered to be an eye irritant.
- Executive summary:
In a primary eye irritation study 100 mg of bis(4-tert-butylcyclohexyl) peroxydicarbonate was instilled into the everted lower lid of one eye of 6 New Zealand White albino rabbits for 24 hours. The eyes were not washed after instillation. Animals were observed after 24, 48 and 72 hours and after 7 days. Irritation was scored with the FDA scoring scale. After 24 hours grade 1 of conjunctivae redness and chemosis was observed in all animals. Chemosis was reversible in all animals after 24 hours, redness diminished after seven days. As in terms of conjunctivae irritation scores score 1 is not considered as positive effect and because of the fully reversibility of the effect, bis(4-tert-butylcyclohexyl) peroxydicarbonate is not considered to be an eye irritant.
Reference
Table 1: Individual scores awarded in the ocular lesions elicited by bis(4-tert-butylcyclohexyl) peroxydicarbonate
Rabbit number |
Cornea |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
||||
After 24 hours |
|||||
1 |
0 |
0 |
1 |
1 |
|
2 |
0 |
0 |
> 1 |
1 |
|
3 |
0 |
0 |
1 |
1 |
|
4 |
0 |
0 |
1 |
1 |
|
5 |
0 |
0 |
> 1 |
1 |
|
6 |
0 |
0 |
1 |
1 |
|
After 48 hours |
|||||
1 |
0 |
0 |
1 |
0 |
|
2 |
0 |
0 |
1 |
0 |
|
3 |
0 |
0 |
1 |
0 |
|
4 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
1 |
0 |
|
6 |
0 |
0 |
1 |
0 |
|
After 72 hours |
|||||
1 |
0 |
0 |
1 |
0 |
|
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
1 |
0 |
|
4 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
1 |
0 |
|
6 |
0 |
0 |
0 |
0 |
|
After 7 days |
|||||
1 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Primary irritation of the skin was measured by a patch-test technique on the abraded and the intact skin of 12 adult New Zealand White albino rabbits. After an exposure period of 24 hours the patches and the material applied were removed and the resulting skin reactions were evaluated by the method of Draize. A second reading was made 48 hours later (72 hours after application). Since the Draize grading system does not comprise abnormalities found in a second reading after 72 h these were carried out on the basis of the CIVO-grading system. The test material did not cause any signs of skin irritation, neither on the intact skin nor on the abraded skin. According to the Draize and CIVO-grading systems di-(4-tert-butylcyclohexyl) peroxydicarbonate is non-irritating to the skin of rabbits.
In an acute eye irritation study according to FDA-standards, 0.1 g of di-(4-tert-butylcyclohexyl)peroxydicarbonate was instilled into the eyes of six New Zealand White albino rabbits. Eyes were not washed after application. Animals then were observed after 24, 48, 72 hours and 7 days. Irritation was evaluated using the FDA scoring-scale. The test material caused slight redness and slight swelling of the conjunctivae in all rabbits. After 48 h the slight swelling of the chemosis was gone. The slight redness of the conjunctivae was reversible after 7 days. During the seven-day observation period the eye lesions recovered completely. Based on the results of this test and according to the FDA-standard the test material is not considered to be an eye irritant in rabbits.
Justification for selection of skin irritation / corrosion endpoint:
Comparable to guideline study with acceptable restrictions (key study).
Justification for selection of eye irritation endpoint:
Comparable to guideline study with acceptable restrictions (key study).
Justification for classification or non-classification
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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