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Diss Factsheets
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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
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- Bis(4-tert-butylcyclohexyl) peroxydicarbonate
- EC Number:
- 239-557-1
- EC Name:
- Bis(4-tert-butylcyclohexyl) peroxydicarbonate
- Cas Number:
- 15520-11-3
- Molecular formula:
- C22H38O6
- IUPAC Name:
- 4-tert-butylcyclohexyl {[(4-tert-butylcyclohexyl)oxy]carbonyl}oxy carbonate
- Details on test material:
- - Name of test material (as cited in study report): Perkadox 16 (Bis(4-tert-butylcyclohexyl)peroxydicarbonate)
- Substance type: organic peroxide
- Physical state: solid
- Storage condition of test material: -20°C
Constituent 1
Test animals / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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