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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20-Jan-1992 to 13-May-1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: This study was performed according to a Solvay Duphar standard operating procedure TDS 032
- Deviations:
- yes
- Remarks:
- Temperature was lower on three days of the study but not lower than 18 degrees celsius. There was a power failure on one day before the last day of the study. None of these deviations are considered to have affected the integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- other: EEC directive, 84-449, Annex V, Part B3.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: Single dermal dose of 2000 mg/kg
- Limit test:
- yes
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:
- other: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals
SPF-derived Hsd/Cpb:WU Wistar rats were obtained from Harlan/CPB, Zeist, The Netherlands. Male rats weighed 175-200 g and females 150-175 g at arrival.
Animal care
The rats were housed continuously in Macrolon cages with two or three animals per cage, except for the application period; then the rats were caged alone. The rats had free access to food (a standard laboratory diet RHM-TM, Hope Farms, Woerden, The Netherlands). Water was available ad libitum. The acclimatisation period was 5 days. Animals were housed in room no. 408, CDA IV, with the following animal room conditions:
Temperature
Relative humidity
Artificial light
18-25°C;
48-70%;
from 7 a.m. till 7 p.m.;
24 hours per day;
Radio-sound
Ventilation
approximately 16 air changes per hour.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: suspended in a 1.25% tragacanth solution in distilled water
- Details on dermal exposure:
- The test procedure used was in accordance with EEC-Directive 84-449, Annex V, Part B3. The animals were individually identified by means of a dye marking system on the fur. The day before the application of the compound , the hair from the back and flanks of male and female rats was removed with an electric clipper. Animals with obvious skin lesions were not used. From the test material suspension, aliquots with a volume of 8 ml/kg body weight were taken, equivalent to 2000 mg/kg, and were uniformly applied over a strip of gauze of about 15 cm2. The gauze was covered with an occlusive Blenderm tape of about 5 x 10 cm, on a wider strip of plaster. The total patch with test material was applied on the back and flanks of each animal and held in place with strips of plaster.
To prevent damaging of the patches, the rats were fitted with collars during the application period. After 24 hours, the collars were removed and the gauze patches were peeled off under light ether anaesthesia. The skin was wiped to remove any remaining test substance. - Duration of exposure:
- The rats were observed at 1, 3, 4, 24 and 28 hours after application and thereafter once on each day till the end of the experiment. Any sign of intoxication which could be ascertained by observation and manipulation of the rats during the 14-day observation period was recorded.
- Doses:
- A single dermal dose of 2000 mg/kg.
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
Clinical signs
The rats were observed at 1, 3, 4, 24 and 28 hours after application and thereafter once on each day till the end of the experiment. Any sign of intoxication which could be ascertained by observation and manipulation of the rats during the 14-day observation period was recorded.
Body weights
The rats were weighed one day before dosing (day -1), at the day of dosing prior to dose administration (day 0), and at 2, 7 and 14 days after treatment.
Autopsy
At-the end of the experiment, the rats were killed by ether inhalation and an autopsy was performed that included inspection of the external appearance, the cervical area, the thoracic and abdominal cavities.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Since none of the rats died within the 14-day observation period, the acute dermal Lo50 was established to be greater than 2000 mg/kg in male and female rats.
- Mortality:
- None of the rats died during the application or observation period.
- Clinical signs:
- other: During the application period, chromodacryorrhoea and dirty noses were noticed from 1 hour after start of the application up to 24 hours after treatment in both males and females. Upon removal of the collars, these signs disappeared. No further symptoms w
- Gross pathology:
- 3 female rats showed a dilated uterus. No abnormalities were noted for the other female and all male rats. Dilatation of the uterus is considered to be a physiological process within the oestrus cycle, which is routinely noticed in approximately 1 out of 5 female animals. Therefore, this finding was considered to be not treatment-related.
- Other findings:
- During the application period, when the rats were wearing collars, chromodacryorrhoea and dirty noses were noticed in males and females. The production of red tears is a normal physiological phenomenon, but is not always noticed due to grooming. In the present study normal grooming behaviour was hindered during the application period by the collars fitted around the neck of the rats. Therefore, chromodacryorrhoea and dirty noses are not considered to be treatment-related signs.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dermal administration of a single dose of 2000 mg/kg of retroketal caused no mortalities among male and female rats during the 14-day observation period.
Only female rats treated with a dermal dose of 2000 mg/kg of retroketal lost some weight in the first few days after treatment. The transient weight loss observed in this study is considered to be a consequence of the study design rather than the test material. Body weight-gains of female rats were normal after the second day of the observation period.
Autopsy of the male and females rats at the end of the observation period did not reveal any macroscopic abnormality, that was considered treatment-related.
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