Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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
Acute Toxicity: dermal
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- 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
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:
- Lupersol 223
- IUPAC Name:
- Lupersol 223
- Details on test material:
- - Name of test material (as cited in study report): Lupersol 223 (Di-(2-ethylhexyl)peroxydicarbonate)
- Substance type: organic peroxide
- Physical state: clear liquid
- Lot/batch No.: OMQG 281
Constituent 1
Constituent 2
Test animals
- 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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.
Applicant's summary and conclusion
- 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.
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.
