Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute toxicity has been tested in an oral toxicity study according to OECD 423 and a dermal toxicity study comparable to OECD 402, at doses of 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-04-02 to 2012-04-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 11 weeks old
- Weight at study initiation: Step 1 / animals no. 1-3: 140-152 g; Step 2 / animals no. 4-6: 162-178 g;
- Fasting period before study: Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted).
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 110811)
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0815)
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: Adequate acclimatisation period (at least five days) under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Sigma, lot no. MKBF8603V, expiry date: 05/2012; suggested by the sponsor
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- For all animals of both steps, 2 g of the test item were dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: corn oil was suggested as vehicle by the sponsor.
- Lot/batch no. (if required): MKBF8603V
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): The test item was weighed out into a tared plastic vial on a precision balance. The dose formulations were made shortly before each dosing occasion at room temperature and were stored on ice until administration.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 female rats per step resulting; 2 steps -> 6 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were examined several times on day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights; all gross pathological changes were recorded and in case of findings the tissues were preserved for a possible histopathological evaluation. - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died.
- Clinical signs:
- other: Reduced spontaneous activity, kyphosis, piloerection and half eyelid-closure. The clinical signs were observed within 4 hours after the administration. Signs of toxicity were fully reversible within 24 hours.
- Gross pathology:
- At necropsy, no macroscopic findings were observed in any animal of any step.
- Other findings:
- no other findings
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of Peroxan EPC S in the rat was determined to be > 2000 mg/kg bw and =< 5000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to OECD guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method) 2 groups of fasted, female Wistar rats Crl: WI(Han) (full barrier) (3 animals per step; 2 steps) were given a single oral dose of Peroxan EPC S (Bis(2-ethylhexyl)peroxydicarbonate) (98.1%) in corn oil at a dose of 2.000 mg/kg bw and observed for14 days. A limit test was conducted. No mortality was observed.
The median lethal dose of PEROXAN EPC S after a single oral administration to female rats, observed over a period of 14 days was determined to be: LD50 cut-off (rat): > 2.000 mg/kg <=5.000 mg/kg.
Reference
The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.
Table 1: Clinical Signs - Individual Data
Animal No. / Sex |
Time of Observation |
Observations |
|
Step 1 (2000 mg/kg Body Weight) |
|||
1 / female, 2 / female, 3 / female |
30 min post-dose |
kyphosis, slight piloerection |
|
1 h post-dose |
slightly reduced spontaneous activity, kyphosis, slight piloerection, half eyelid-closure |
||
2 h post-dose |
slightly reduced spontaneous activity, kyphosis, moderate piloerection, half eyelid-closure |
||
3 h post-dose |
moderately reduced spontaneous activity, kyphosis, moderate piloerection, half eyelid-closure |
||
4 h post-dose |
slightly reduced spontaneous activity, moderate piloerection, half eyelid-closure |
||
d 2 until the end of the observation period |
no signs of toxicity |
||
d = day (day 1 = day of administration); h = hour(s); min = minute(s)
Table 2: Clinical Signs - Individual Data
Animal No. / Sex |
Time of Observation |
Observations |
|
Step 2 (2000 mg/kg Body Weight) |
|||
4 / female, 5 / female, 6 / female |
30 min post-dose |
kyphosis |
|
1 h post-dose |
slightly reduced spontaneous activity, slight piloerection, half eyelid-closure |
||
2 h post-dose |
slightly reduced spontaneous activity, kyphosis, slight piloerection, half eyelid-closure |
||
3 h post-dose |
slightly reduced spontaneous activity, moderate piloerection, half eyelid-closure |
||
4 h post-dose |
slightly reduced spontaneous activity, moderate piloerection, half eyelid-closure |
||
d 2 until the end of the observation period |
no signs of toxicity |
||
d = day (day 1 = day of administration); h = hour(s); min = minute(s)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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: Guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- : no analytics; 2 animals/sex/dose
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1810 to 2450 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: gauze bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid tap water
- Time after start of exposure: 24 h - Duration of exposure:
- 24 h
- Doses:
- 200 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 2
- Control animals:
- not specified
- Details on study design:
- The hair was removed from the back of each rabbit with an electric clipper. The skin of one male and one female rabbit in each group was abraded with a scalpel blade.
The test material was applied only once, following which the site of application was occluded and wrapped with a gauze bandage. 24 hours later the bandages were removed and the backs washed with tepid tap water.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at the beginning of the study, 7 days and 14 days after compound application
- Necropsy of survivors performed: no - Statistics:
- none
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- None
- Other findings:
- At 24 hours following application, erythema (moderate to marked) and edema (slight to moderate) was observed in all rabbits. Additionally blanching was observed. Desquamation was noted during the 14 day observation period. Each of the rabbits showed gains in body weight during the observation period.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 is > 2000 mg/kg. Thus, the test item is not considered a toxic substance by the dermal route of administration.
- Executive summary:
In an acute dermal toxicity study groups of male and female New Zealand white rabbits (2 male and 2 females) were dermal exposed in a limit test to Lupersol 223(Bis-(2 -ethylhexyl)) peroxycarbonate for 24 hours at doses of 200 and 2000 mg/kg bw. Animals then were observed for 14 days. At 24 hours following application, erythema (moderate to marked) and edema (slight to moderate) was observed in all rabbits. Additionally blanching was observed. Desquamation was noted during the 14 day observation period. Each of the rabbits showed gains in body weight during the observation period.
The dermal LD0 is 2000 mg/kg bw. Lupersol 223 (Bis-(2 -ethylhexyl)peroxycarbonate) is not toxic by the dermal route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
No mortality has been reported in an acute oral toxicity study according to OECD 423 and a dermal toxicity study comparable to OECD 402.
Justification for selection of acute toxicity – oral endpoint
No mortality was observed in an acute oral toxicity GLP study according to OECD 423 at a limit dose of 2000 mg/kg bw.
Justification for selection of acute toxicity – dermal endpoint
No mortality was observed in an acute dermal toxicity study similar to OECD 402 at a limit dose of 2000 mg/kg bw.
Justification for classification or non-classification
No mortality has been reported in an acute oral toxicity study according to OECD 423 or a dermal toxicity study comparable to OECD 402.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.