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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-12-10 to 2010-03-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 24 April 2002
- Deviations:
- yes
- Remarks:
- see box " Principles of method if other than guideline"
- Principles of method if other than guideline:
- The purpose of this study was to determine the sensitising potential of Dicumyl peroxide in the local lymph node assay in mice. The study was performed according to OECD 429, however not employing the use of radioactive labelling to measure cell proliferation, as the radioactive method proposed by the OECD guideline led to problems in various EU laboratories: such as (i) practical difficulties/complexity of the test, in particular the radiochemical steps, which sometimes resulted in loss of specimen/activity; this in turn led to variability in the results and to a poor reproducibility and (ii) radiation protection issues. However, the OECD guideline allows other endpoints for assessment of proliferation in form of lymph node cell counts and lymph node weights if justification and appropriate
scientific support exist showing the validity of this method. The alternative method used for the study employing the lymph node weight and lymph node cell count to assess proliferation has been established by an European inter-laboratory validation exercise, as described in the two publications by Ehling et al. 2005a and 2005b. In addition, the acute inflammatory skin reaction is measured by ear weight determination of circular biopsies of the ears and ear thickness measurements on test day 1 and test day 4 to identify skin irritation properties of the test item. Stimulation indices were calculated for the lymph node cell count, lymph node weight, ear weight and ear thickness by dividing the average values per group of the test item treated animals by the vehicle treated ones. Values above 1.4 (lymph node cell count to identify sensitisation) or 1.1 (ear weight to identify irritation) are considered positive (these values were fixed empirically during the inter-laboratory validation of this method (Ehling et al. 2005a and 2005b). - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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): Dicumylperoxide
- Molecular formula (if other than submission substance): C18H22O2
- Substance type: white crystalline powder
- Physical state: solid
- Analytical purity: 99.5% (based on CoA)
- Purity test date: 07.12.2009
- Lot/batch No.: 44229 (receipt no.)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 12 weeks
- Weight at study initiation: 20-25 g
- Housing: singly in MAKROLON cages (type III)
- Diet (e.g. ad libitum): ssniff R/m-H V1534, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- given in report as (3+1, v/v)
- Concentration:
- 10%, 25%, and 50% (w/w) in 25 µL
- No. of animals per dose:
- 6 females
- Details on study design:
- RANGE FINDING TESTS:
perfomed with 1 animal each at 10, 25 and 50% (25 µL/ear)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Index for lymph node cell count above 1.4 and index for ear weight above 1.1 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mann & Whitney U-test , concentration-response-relationship examined by linear regression analysis using Pearsons's correlation coefficient.
Results and discussion
- Positive control results:
- The positive control revealed a significant increase in lymph node cell count above the threshold of 1.4. Therefore, the test was considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- Mean of six animals
- Value:
- 1
- Test group / Remarks:
- Negative control
- Key result
- Parameter:
- SI
- Remarks:
- Mean of six animals
- Value:
- 1.086
- Test group / Remarks:
- 10%
- Remarks on result:
- other: The simulation index for lymph node cell count did not exceed the threshold of 1.4. Hence, the test item is classified as not sensitising.
- Key result
- Parameter:
- SI
- Remarks:
- Mean of six animals
- Value:
- 1.339
- Test group / Remarks:
- 25%
- Remarks on result:
- other: The simulation index for lymph node cell count did not exceed the threshold of 1.4. Hence, the test item is classified as not sensitising.
- Key result
- Parameter:
- SI
- Remarks:
- Mean of six animals
- Value:
- 1.384
- Test group / Remarks:
- 50%
- Remarks on result:
- other: The simulation index for lymph node cell count did not exceed the threshold of 1.4. Hence, the test item is classified as not sensitising.
- Parameter:
- SI
- Value:
- 1.764
- Test group / Remarks:
- Positive control
- Remarks on result:
- other: The positive control group caused an increase in lymph node cell count above the threshold of 1.4.
Any other information on results incl. tables
Table 1: Stimulation indices
Parameter |
Group 1, negative control |
Group 2, 10% |
Group 3, 25% |
Group 4, 50% |
Group 5, positive control |
Lymph node cell count |
1 |
0.086 |
1.339 |
1.384 |
1.764* |
Lymph node weight |
1 |
1.400 |
1.909* |
1.954* |
2.127* |
Ear weight |
1 |
0.949 |
0.916* |
0.888* |
0.762* |
Ear thickness |
1 |
1.032 |
1.036 |
1.044 |
1.104 |
*: sign. at p< 0.01
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The result of the LLNA test perfomed with dicumyl peroxide revealed that dicumyl peroxide is not senstizing to skin.
- Executive summary:
In a dermal sensitisation test conducted according to OECD 429, female CBA mice (six/group) were treated with concentrations of 10, 25 and 50% test item in acetone/olive oil (3 +1 v/v). No changes in behaviour were observed in any of the treated animals.The result of the LLNA test indicated, that dicumyl peroxide is not sensitizing to skin when tested at concentration up to 50%.
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