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EC number: 611-207-6 | CAS number: 5488-51-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-Jan-1992 to 11-Mar-1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed to OECD test guideline and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Due to a malfunction of a thermohygrograph the temperature and the relative humidity in the animal room were not recorded on two dates. This deviation was not considered to have affected the integrity of the study performed.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (9R,10S,13S)-10,13-dimethyl-17-(2-methyl-1,3-dioxolan-2-yl)spiro[1,2,4,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,2'-1,3-dioxolane]
- EC Number:
- 611-207-6
- Cas Number:
- 5488-51-7
- Molecular formula:
- C25H36O4
- IUPAC Name:
- (9R,10S,13S)-10,13-dimethyl-17-(2-methyl-1,3-dioxolan-2-yl)spiro[1,2,4,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,2'-1,3-dioxolane]
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- SPF-derived male New Zealand White rabbits (2.5-3.0 kg) were obtained from Harlan Olac, Zeist, The Netherlands. The animals were inspected for signs of illness at the beginning of the acclimatization period. No abnormalities were detected.
Animal care
Three rabbits were individually housed in stainless steel wire cages KK 102. Sawdust, woodchips, or other extraneous material that might produce skin irritation were excluded. The rabbits received 80 g food (a standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands) per day during the acclimatization period of 5 days. During the experiment the animals had free access to food and water. Animals were housed in room no. 301, CDA Ill with the following animal room conditions:
Temperature 18-20'C;
Relative humidity 60-74%;
Artificial light from 7 a.m. till 7 p.m.;
Radio-sound on 12 hours per day;
Ventilation approximately 16 air changes per hour.
Treatment
The test procedure used was in accordance with OECD guideline 404, adopted on 12 May 1981. On the last day of the acclimatization period the backs of the three rabbits were clipped free of hair. A 6 cm2 patch was prepared, 0.5 g of the test material was applied and was moistioned with 0.5 ml water. The patch was sustained by occlusive Blenderm tape and secured in place on the back of the animal 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.
At 30-60 minutes and at 24, 48 and 72 hours after patch removal, the skin reactions caused by the test substance were scored.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Amount / concentration applied:
- A 6 cm2 patch was prepared, 0.5 g of the test material was applied and was moistioned with 0.5 ml water. The patch was sustained by occlusive Blenderm tape and secured in place on the back of the animal by adhesive tape.
- Duration of treatment / exposure:
- 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.
- Observation period:
- At 30-60 minutes and at 24, 48 and 72 hours after patch removal, the skin reactions caused by the test substance were scored.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: A 6 cm2 patch was prepared, 0.5 g of the test material was applied and was moistioned with 0.5 ml water.
- Type of wrap if used: The patch was sustained by occlusive Blenderm tape and secured in place on the back of the animal by adhesive tape.
REMOVAL OF TEST SUBSTANCE
The patch was sustained by occlusive Blenderm tape and secured in place on the back of the animal 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.
SCORING SYSTEM:
Evaluation of skin reactions
At 30-60 minutes and at 24, 48 and 72 hours after patch removal, the skin reactions caused by the test substance were scored on the basis of the grades described in the following table.
Erythema and eschar formation Grade
No erythema 0
Very slight erythema (barely perceptable) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation
No oedema 0
Very slight oedema (barely perceptable) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending
beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Retroketal is considered to cause no skin irritation in rabbits. The test material is therefore classified as non-irritant according to EEC labelling regulations. No symbol and no risk phrase are required.
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