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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 243-424-3 | CAS number: 19910-65-7
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Date: July 17, 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: the requirements of the Federal Hazardous Substances Act would be considered an eye irritant
- Principles of method if other than guideline:
- Prior to compound administration, the eyes of each rabbit were examined with ultraviolet light after instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.
A volume of 0.1 ml of the test material was instilled into the cupped conjunctival sac of the right eye of each rabbit.
Examinations were made for ocular irritation at 24, 48 and 72 hours. At the 72 hour examination, sodium fluorescein and ultraviolet light were used to aid in revealing possible corneal injury. - GLP compliance:
- no
Test material
- Reference substance name:
- Bis-sec-butyl peroxydicarbonate
- EC Number:
- 243-424-3
- EC Name:
- Bis-sec-butyl peroxydicarbonate
- Cas Number:
- 19910-65-7
- Molecular formula:
- C10H18O6
- IUPAC Name:
- 2-[({[(butan-2-yloxy)carbonyl]peroxy}carbonyl)oxy]butane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- The test materials were received from the Lucidol Division, Pennwalt Corporation, Buffalo, New York, on June 12, 1970.
The test material was identified as follows:.
"Lupersol 22SM, Di (sec-Butyl) Peroxydicarbonate".
Each was received as a clear liquid packed in dry ice.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Nine male and 9 female albino New Zealand White rabbits weighing from 1858 to 2447 grams were used for this test. Each rabbit was housed individually in hanging metal cages and maintained in temperature and humidity controlled quarters throughout the test. Purina Rabbit Chow and water were available ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- The rabbits were divided into 3 groups of 3 male and 3 female rabbits each. Each group was used to examine one of the three test materials for eye irritation.
Prior to compound administration, the eyes of each rabbit were examined with ultraviolet light after instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.
A volume of 0.1 ml of the test material was instilled into the cupped conjunctival sac of the right eye of each rabbit.
Examinations were made for ocular irritation at 24, 48 and 72 hours. At the 72 hour examination, sodium fluorescein and ultraviolet light were used to aid in revealing possible corneal injury.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 12.6
- Max. score:
- 50
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 10.2
- Max. score:
- 50
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 8.2
- Max. score:
- 50
- Reversibility:
- not specified
Any other information on results incl. tables
At each observation interval, conjunctival irritation in varying degrees was observed in each of the 6 animals tested. The irritation noted consisted of slight to moderate redness, slight to marked chemosis and very slight to slight discharge.
Seventy-two hours following instillation of the test material, each eye was examined with ultraviolet light and sodium fluorescein.
No corneal damage was observed.
Based upon the results obtained Lupersol 225M would be considered an eye irritant.
Eye irritation in the Rabbit:
Ocular Area |
Average Scores (Range) |
|||
Observation Period (hours) |
||||
24 |
48 |
72 |
||
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 |
1.9 (1.5-2.5) |
1.7 (1.0-2.5) |
1.3 (0.5-2.0) |
|
B |
3.5 (3.0-4.0) |
2.7 (2.0-4.0) |
2.3 (2.0-2.5) |
|
C |
0.9 (0.5-1.5) |
0.7 (0.5-1.0) |
0.5 (0.5) |
Conjunctivae Score |
|
12.6 |
10.2 |
8.2 |
Total Score |
|
12.6 |
10.2 |
8.2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based upon the results obtained Lupersol 225M would be considered an eye irritant.
- Executive summary:
Three test materials (Lupersol 223 , Lupersol 225M and D-199 P) were examined for eye irritation and dermal toxicity in the albino rabbit.
Each of the test materials when examined in accordance with the requirements of the Federal Hazardous Substances Act would be considered an eye irritant.
Based upon the results obtained Lupersol 225M would be considered an eye irritant.
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.