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EC number: 240-282-4 | CAS number: 16111-62-9
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-08-01 to 1995-08-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(2-ethylhexyl) peroxydicarbonate
- EC Number:
- 240-282-4
- EC Name:
- Bis(2-ethylhexyl) peroxydicarbonate
- Cas Number:
- 16111-62-9
- Molecular formula:
- C18H34O6
- IUPAC Name:
- 3-({[({[(2-ethylhexyl)oxy]carbonyl}peroxy)carbonyl]oxy}methyl)heptane
- Reference substance name:
- Di-(2-Ethylhexyl)-Peroxydicarbonate
- IUPAC Name:
- Di-(2-Ethylhexyl)-Peroxydicarbonate
- Details on test material:
- - Name of test material (as cited in study report): Luperox 223-M-75 (Di-(2-Ethylhexyl)-Peroxydicarbonate)
- Substance type: organic peroxide
- Physical state: colourless liquid
- Analytical purity: 75.8 % in hydrocarbon
- Lot/batch No.: 802-9409-01
- Storage condition of test material: at -20°C and protected from light
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.4 kg +/- 0.2 kg
- Housing: individually
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the substance was used in original form (75.8% in hydrocarbon)
- Controls:
- other: untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the test substance in active material corresponding to 0.66 ml in the finished product
- Concentration (if solution): 75.8 % in hydrocarbon - Duration of treatment / exposure:
- The test substance was applied in a first assay for a period of 3 min and 4 h in one male New Zealand white rabbit. Since the substance was not strongly irritating in the first assay, it was applied for 4 h in a second assay.
- Observation period:
- The observation period was extended to a maximum of 14 days (until day 15) in order to determine the progress of lesions and their reversibility.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm^2
- Type of wrap if used: dry gauze pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped of with moistened (4 h exposure) or dry (3 min exposure) gauze pad
- Time after start of exposure: 3 min or 4 h
SCORING SYSTEM: scoring scale 0-4 see table 1 in "any other information on materials and methods"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 3 min
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 4 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 4 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 4 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 4 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 4 h
- Score:
- >= 0 - <= 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 4 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Other effects:
- dryness of the skin observed in all animals latest on day 5 after 4 h exposure and on day 7 after 3 min exposure
Any other information on results incl. tables
Table 2: Mean irritant response data after 4 h exposure at day 2, 3 and 4
Rabbit number |
Dermal Irritation |
Mean irritation score (#) |
Interpretation |
1 |
Erythema |
1.3 |
(-) |
Oedema |
0.7 |
(-) |
|
Other |
Dryness of skin from day 7 onwards |
|
|
2 |
Erythema |
2.0 |
(+) |
Oedema |
3.3 |
(+) |
|
Other |
Dryness of skin from day 5 onwards |
|
|
3 |
Erythema |
2.0 |
(+) |
Oedema |
2.0 |
(+) |
|
Other |
Dryness of skin from day 5 onwards |
|
(#) mean irritation score on days 2, 3 and 4
(+) = irritant according to E.E.C. criteria
(-) = non-irritant according to E.E.C. criteria
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the test substance Di-(2-Ethylhexyl)-peroxycarbonate was considered irritant in rabbits. All effects were reversible.
- Executive summary:
In a primary dermal irritation study according to the OECD guideline 404, 3 male rabbits (New Zealand white; 2.4 +/-0.2 kg) were dermally exposed to 0.5 ml of Di-(2-Ethylhexyl)-peroxydicarbonate (undiluted test material; 75.8 % in hydrocarbon) which corresponds to 0.66 ml in the finished product. The test sites were covered with a semi-occlusive dressing for 3 minutes and 4 hours, respectively. Animals were then observed for 14 days until day 15. The mean values of the scores for erythema and oedema were calculated for each animal.
After 3 minutes exposure very slight erythema (grade 1) was observed up to day 7; dryness of the skin was noted from day 7 onwards, masking evaluation of the erythema up to day 10.
After 4 hours of exposure very slight or slight erythema (grade 1 or 2) was observed up to days 4, 6 or 7. Slight or severe oedema (grade 2 and 4) was noted for 24 h in one animal, and up to day 4 in another animal. In the remaining rabbit, slight oedema was noted from days 2 to 4.
Dryness of the skin was observed from day 5 (two rabbits) or 7 to days 11, 13 or 15. It masked evaluation of erythema in one rabbit on day 5 and in animal on days 8 to 10.
Mean scores over 24, 48 and 72 hours for individual animals were 1.3, 2.0 and 2.0 for erythema and 0.7, 3.3 and 2.0 for edema.
In this study, Di-(2-Ethylhexyl)-peroxydicarbonate is a dermal irritant to the skin.
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