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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
Endpoint summary
Administrative data
Description of key information
GLP guideline studies according to OECD 404 and OECD 405.
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
- Study period:
- 1995-08-01 to 1995-08-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- 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 - 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" - 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
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: reversibiltiy of effects have not been tested
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : reversibility after 21 days was not examined, no individual animal data
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1858 to 2447 g
- Housing: individually
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained throughout study
- Humidity (%): maintained throughout study
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Instilled into the conjunctival sac of the right eye in each rabbit. Exposure throughout the observation period.
- Observation period (in vivo):
- Observation after 24 h, 48 h and 72 h
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- SCORING SYSTEM: Scale for scoring ocular lesions (Draize, J.H., 1959)
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 14.6
- Reversibility:
- not specified
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 13.6
- Reversibility:
- not specified
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 13
- Reversibility:
- not specified
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- other: Conjunctivae Redness
- Basis:
- mean
- Time point:
- other: 24
- Score:
- >= 2 - <= 2.5
- Max. score:
- 2.5
- Reversibility:
- not specified
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- other: Conjunctivae Redness
- Basis:
- mean
- Time point:
- other: 48
- Score:
- >= 1 - <= 2.5
- Max. score:
- 2.5
- Reversibility:
- not specified
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- other: Conjunctivae Redness
- Time point:
- other: 72 h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: no data of individual animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: no data on individual animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: no data on individual animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: no data on individual animals
- Irritation parameter:
- other: Conjunctivae Discharge
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- >= 0.5 - <= 2.5
- Max. score:
- 2.5
- Reversibility:
- not specified
- Remarks on result:
- other: no data on individual animals
- Irritation parameter:
- other: Conjunctivae Discharge
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- >= 0.5 - <= 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: no data on individual animals
- Irritation parameter:
- other: Conjunctivae Discharge
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- >= 0.5 - <= 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: no data on individual animals
- Irritant / corrosive response data:
- - varying degrees of conjunctival irritation in each animal at each observation level
- slight to marked redness, moderate to marked chemosis, very slight to moderate discharge
- no corneal damage - Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results Lupersol 223 would be considered an eye irritant.
- Executive summary:
Lupersol 223 (Di-(Ethylhexyl)Peroxydicarbonate) was tested in 3 male and 3 female rabbits (New Zealand white) for eye irritation. An amount of 0.1 ml of the test substance was instilled into the conjunctival sac of the right eye of each rabbit. The eyes were not washed. Examinations were made after 24, 48 and 72 h and scored according Draize et al. 1959. Varying degrees of conjunctival irritation were observed in each test animal at each observation interval. These findings included slight to marked redness, moderate to marked chemosis and very slight to moderate discharge. Examination of the treated eyes at 72 h with UV light and sodium fluorescein did not reveal corneal damage. Adverse effects were observed but the observation period was not extended to 21 days to exclude a chronic effect. No data of the individually tested animals are provided but the average score. In this study Lupersol 223 (Di-(Ethylhexyl)Peroxydicarbonate) is an eye irritant.
Reference
Table 1: Eye irritiation in the rabbit caused by Lupersol 223 (Di-(2-Ethylhexyl)Peroxydicarbonate)
Ocular area |
Eye irritation in the rabbit |
Observation period and average score (range) |
||
24h |
48h |
72 h |
||
Cornea |
A |
0 |
0 |
0 |
B |
0 |
0 |
0 |
|
Cornea score |
|
0 |
0 |
0 |
Iris |
A |
0 |
0 |
0 |
Iris score |
|
0 |
0 |
0 |
Conjunctivae |
A |
2.2 (2.0-2.5) |
2.1 (1.0-2.5) |
1.8 (1.0-3.0) |
B |
3.8 (3.0-4.0) |
3.6 (3.0-4.0) |
3.7 (3.0-4.0) |
|
C |
1.3 (0.5-2.5) |
1.1 (0.5-2.0) |
1.0 (0.5-2.0) |
|
Conjunctivae score |
|
14.6 |
13.6 |
13.0 |
Total score |
|
14.6 |
13.6 |
13.0 |
A: Redness
B: Chemosis
C: Discharge
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation was tested in a GLP guideline study (CIT, 1995) according to OECD 404. Irritation scores were in the range of 1.3 to 2.0 (erythema) and 0.7 to 3.3 (oedema). All effects were reversible. The findings did not contradict an older study (CIVO, 1983) that was performed similar to OECD 404. The substance used in the latter study was not characterised sufficiently to rate the study as reliable.
Eye irritation: The test item produced
effects on the conjunctiva in 2 of 3 tested animals. Reversibility was
not examined. The effects did not show a clear decrease within 3
consecutive days. Thus, it cannot be concluded that the effects would be
reversible within 21 days. The test item did not fulfil the alternative
criteria scoring corneal opacity ≥ 3 and/or — iritis > 1,5. However,
according to regulation 1272/2008 irreversible effects lead to
classification as Category 1 (Irreversible effects on the eye). Thus Cat
1 is warranted based on missing data on the reversibility of the effect.
Justification for selection of skin irritation / corrosion endpoint:
key study
Justification for selection of eye irritation endpoint:
key study
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Skin irritation was tested according to OECD 404. Irritation scores were in the range of 1.3 to 2.0 (erythema) and 0.7 to 3.3 (oedema). Only one of 3 animals had edema scores above 2.0. All effects were reversible. According to CLP this would be considered a borderline case and no classification would be warranted. Due to the slightly more severe irritation scores reported in the second, less reliable study (using a poor defined substance) the current classification (Skin Irrit Cat 2) was maintained.
Eye irritation was tested according to OECD 405. The test item produced effects on the conjunctiva in 2 of 3 tested animals. Reversibility of these effects was not examined. Two animals showed a slow decrease in the irritation score between the 24 and 96 h readings. The third animal did not show a decrease in the effect level within 3 consecutive days. Thus it was not possible to conclude a reversibility of the effects within 21 days. The test item did not fulfil the alternative criteria scoring corneal opacity ≥ 3.0 and/or — iritis > 1.5. Thus the justification for classification as Category 1 (irreversible effects on the eye) is weak and based only on the missing proof of reversible effects on the conjunctiva.
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