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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 243-175-0 | CAS number: 19592-55-3
- 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:
- 13 May to 16 May, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In accordance with OECD and EU guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC-Directive 84-449, Annex V, part 84
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- EC Number:
- 243-175-0
- EC Name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- Cas Number:
- 19592-55-3
- Molecular formula:
- C25H36O4
- IUPAC Name:
- (1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]
- Test material form:
- other: crystalline powder
- Details on test material:
- Off-white crystalline powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Itta Credo-Broekman, B.V., Someren
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: Three rabbits individually housed in stainless steel wire cages KK 102. Sawdust, woodchips, or other extraneous material that might produce skin irritation were excluded.
- Diet (e.g. ad libitum): 80 g food (a standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands) per day during the acclimatization period.
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 50-70%
- Air changes (per hr): 16
- Photoperiod: Artificial light from 7 a.m. till 7 p.m.; Radio-sound on 24 hours per day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hrs.
- Observation period:
- At 45 minutes and at 20.5, 44 and 68 hours after patch removal, the skin reactions caused by the test substance were scored on the basis of the grades.
- Number of animals:
- 3 male rabbits
- Details on study design:
- On the last day of the acclimatization period the backs of the three rabbits were clipped free of hair. A single area on each animal was used for the application of the test material. For each animal an occlusive patch was made, that consisted of a layer of gauze, an impermeable layer of Blenderm and a layer of Leukoplast adhesive tape. A sample of 0.5 g proketal was introduced on an area of 6 cm2 of the gauze. In order to establish a procedure with minimal loss of test material, the application procedure varied slightly among the three animals. With respect to animal number 1, test material, moistened with 0.5 ml water, was placed on a dry patch. For the other animals, the patch was moistened with 0.5 ml water before application of test material. The latter procedure was considered to be better. The patches were secured in place by adhesive tape.
The animals were fitted with Elizabethan collars (IMS, Cheshire, UK) in order to prevent disturbance of the application for 4 hours. After this period the collars and patches were removed and the skin was wiped to remove any remaining test substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects:
- In one rabbit (animal number 2), no hair growth was observed at and around the application site during the study period. Since the initiation of hair growth after shaving is variable in rabbits, this finding was not considered a consequence of treatment with proketal.
Any other information on results incl. tables
In contrast to standard operation procedure TDS 038, the rabbits were not housed in KK100 cages, but in KK 102 cages. In contrast to TDS 038, the application sites were inspected for signs of irritation at approximately 24, 48 and 72 hours after initiation of treatment.This resulted in observation times of approximately 20, 12, 44 and 68 hours after patch removal. In order to establish a procedure with minimal loss of test material, the application procedure varied slightly among the three animals. These deviations were not considered to affect the integrity of the study performed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single application of proketal for four hours caused no irritation to the shaven intact skin of male rabbits. According to the standards described in EEC-Directive 83-467, proketal does not need a symbol or a risk phrase with respect to skin irritation.
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.