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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
Endpoint summary
Administrative data
Description of key information
Dicumyl peroxide was found to be not irritating to skin and eye.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- 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 - 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 - 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.
- 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.
Reference
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 |
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:
- 2009-12-10 to 2010-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT breeding station Löhndorf, Germany
- Age at study initiation: 6.5–7.5 months
- Weight at study initiation: 2.4, 2.7, and 3.0 kg
- Housing: single
- Diet (e.g. ad libitum): ssniff K-H V2333, ssniff Spezialdiäten GmbH, Soest; ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 20 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30–70 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of mortared test iteminto one eye - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 1 d test, 72 h follow-up period
- Number of animals or in vitro replicates:
- 3 (test was initially performed using 1 animal; as no corrosive or servere irritant effects were observed, 2 further animals were employed 24 after start of first initial test)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 20mL 0.9% NaCl solution
- Time after start of exposure: 1h
SCORING SYSTEM: cornea: max. score 4, iris: max. score 2, conjunctivae: max. score 3, chemosis: max. score 4 (for specification of score see test report)
TOOL USED TO ASSESS SCORE: Hand-slit lamp and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Corneal opacity (grade 1) was observed in animal no. 3 twenty-four and fourty-eight hours after instillation. The fluorescein test performed twenty-four hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface). Conjunctival redness (grade 1) was observed in all animals 60 minutes, in animals nos. 2 and 3 until twenty-four hours after instillation. The irises were not affected by instillation of the test item.
- Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of the study the substance was not irritating when tested on rabbit eye.
- Executive summary:
In a primary eye irritation study (OECD 405), 0.1 g of the test item was instilled into the conjunctival sac of one eye of each of three young adult Himalayan rabbits. Animals were observed for 14 days. Irritation was scored by the method of Draize. The behaviour and physical state of the rabbits, and the body-weight evolution were normal throughout the study. Only very mild conjunctival and corneal opacity reactions were observed, which were fully reversible within 72 hours. Based on the results, the test item can be considered as not irritating.
Reference
Table 1: Effects of 100 mg dicumylperoxide in the right rabbit eye
|
Cornea |
Iris |
Conjunctivae |
|
|
Opacity |
|
Redness# |
Chemosis## |
|
|
animal no.: 1/2/3 |
|
|
Before dosing |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
60 min |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
24h |
0/0/1 |
0/0/0 |
0/1/1 |
0/0/0 |
48h |
0/0/1 |
0/0/0 |
0/0/0 |
0/0/0 |
72h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
# refers to palpebral and bulbar conjunctivae; excluding cornea and iris
## swelling: refers to lids and/or nictating membrane
left eye: untreated control, all scores 0/0/0
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a study according to OECD guideline 404 dicumyl peroxide was found to be not irritating to skin based on EU criteria, when tested semi-occlusive on rabbit skin. Very slight erythema and oedema was observed in two and one animal after 24 h, respectively. No effects were observed after 72 h.
In a study according to OECD guideline 405 dicumyl peroxide was found to be not irritating to eye based on EU criteria, when tested in rabbit eyes.
Justification for classification or non-classification
Based on the results of reliable experimental studies classification of dicumyl peroxide as skin or eye irritant is not warranted based on EU regulation 1272/2008.
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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