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Diss Factsheets
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EC number: 201-279-3 | CAS number: 80-43-3
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(α,α-dimethylbenzyl) peroxide
- EC Number:
- 201-279-3
- EC Name:
- Bis(α,α-dimethylbenzyl) peroxide
- Cas Number:
- 80-43-3
- Molecular formula:
- C18H22O2
- IUPAC Name:
- 1,1'-(dioxydipropane-2,2-diyl)dibenzene
- Details on test material:
- - Name of test material (as cited in study report): Perkadox BC (Dicumylperoxide)
- Substance type: organic
- Physical state: white crystalline powder
- Analytical purity: 99.61%
- Impurities (identity and concentrations): not specified
- Purity test date: 09.06.1992
- Lot/batch No.: 041920580858
- Storage condition of test material: in refrigerator
- Other: certifcate of analysis attached in report
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: 3.5 to 4 months
- Weight at study initiation: 2.9 to 3.12 kg
- Housing: individually
- Diet: standard pelleted rabbit diet (SQC Rabbit Diet, Special Diets Services Ltd), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: not specified (based on infromation in report assumed to be more than a week)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22 °C
- Humidity (%): 45-56%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- 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:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6x6 cm
- Type of wrap if used: unmedicated gauze (3x2cm), held in place on the left site by strips of blenderm; right site, acting as a control, was covered by a similar semi-occlusive dressing but otherwise remained untreated
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: after 4h
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See table below.
Any other information on results incl. tables
Table 1: Skin irritation scores according to Draize
|
|
|
|
Response |
|
Time of observation |
Rabbit No. |
||
|
|
1 |
2 |
3 |
Erythema |
|
|
|
|
|
1 h |
0 |
1 |
1 |
|
24 h |
0 |
1 |
1 |
|
48 h |
0 |
1 |
0 |
|
72 h |
0 |
0 |
0 |
Edema |
|
|
|
|
|
1 h |
0 |
0 |
0 |
|
24 h |
0 |
1 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of the study, the substance was not irritating when tested on rabbit skin.
- Executive summary:
In a primary dermal irritation study (OECD guideline 404), three male New Zealand white rabbits were dermally exposed to 0.5 mg of the test item for 4 hours to a body surface area of 6 cm² under semi-occlusive conditions. Animals then were observed for 1, 24, 48 and 72 hours after removal of the dressings and test substance. The test item did not cause any skin effects, except very slight erythema observed in two rabbits during the first 24 h following bandage removal, continuing in one rabbit after 48 hours. Very slight oedema was evident at one test site at the 24 h observation. The test site of both these rabbits was overtly normal at the 72-h examination. Based on the results, the test item is considered to be non-irritating.
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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