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EC number: 246-529-2 | CAS number: 24916-90-3
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 11 October 2011 and 01 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Done by OECD and GLP standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The methodology for the LLNA is detailed in the OECD Guideline for the Testing of Chemicals, No. 429, and Method B.42 of Commission Regulation (EC) No. 440/2008. The study described in this document is based on these test methods but has been refined in order to reduce the number of animals required. The reduced LLNA (rLLNA) has been endorsed by the non-Commission members of the European Centre for the Validation of Alternative Methods (ECVAM) Scientific Advisory Committee (ESAC) at its 26th meeting held on 26 – 27 April 2007 at ECVAM, Ispra, Italy.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione
- EC Number:
- 246-529-2
- EC Name:
- 9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione
- Cas Number:
- 24916-90-3
- Molecular formula:
- C22H28O5
- IUPAC Name:
- 9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione
- Test material form:
- solid: crystalline
- Details on test material:
- Sponsor's identification : GR46708X
Description : pale yellow crystalline solid
Purity : >98%
Date received : 04 July 2011
Expiry date : 30 June 2012
Storage conditions : room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Supplied by Harlan Laboratories UK Ltd., Oxon, UK.
Acclimatization period of at least five days
Weight range of 15 to 23 g, and were eight to twelve weeks old
Free access to mains tap water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively
Air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: topical application
- Vehicle:
- other: dimethyl formamide
- Concentration / amount:
- The mice were treated by daily application of 25 µl of the test item
Challengeopen allclose all
- Route:
- other: injected via the tail vein
- Vehicle:
- other: dimethyl formamide
- Concentration / amount:
- The mice were treated by daily application of 25 µl of the test item
- No. of animals per dose:
- 5
- Details on study design:
- Clinical Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
Bodyweights: The bodyweight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination). - Challenge controls:
- A further group of five mice received the vehicle alone in the same manner
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- other: phosphate buffered saline
- Concentration:
- 3HTdR: 80 µCi/ml, specific activity 2.0 Ci/mmol, ARC UK Ltd) giving a total of 20 µCi to each mouse
- No. of animals per dose:
- All test and contol mice
- Details on study design:
- The mice were treated by daily application of 25 μl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3) by using a micropipette whose tip is used to spread the formulation over the dorsal surface of each ear. On Day 6 all mice were injected with 250 ul of a phophate buffered saline solution containing 3H-methyl thymidine (3HTdR ) to the tail vein giving a total of 20 uCi to each mouse. All animals were observed twice daily on Day 1, 2 and 3 and once daily on days 4 ,5, and 6. Any signs of toxicity or ill health were noted. Body weights of each mouse were recorded before dosing and before termination. Five hours after administration of 3HTdR all mice were killed by carbon dioxide asphyxiation and their auricular lymph nodes were excised and a 1 ml of phosphate buffered saline was added to each set of lymph nodes. Preparation of a single cell suspension was completed for the lymph nodes cells for each individual animal following standard procedures. Determination of the 3HTdR incorporation was completed by measuring radioactive disintegration for each animal's lymph node cells by using a beta-scintillation counter.
- Statistics:
- Analysis of variance (ANOVA) was carried out on the data followed by Barlett's test for analysis of homogenicity of variance. Comparisons were made beween the control and treatment groups using Dunnett's test.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Concentration (10% w/w) in dimethyl formamide: SI = 0.89
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Concentration (10% w/w) in dimethyl formamide: mean dpm/animal 1843.90 (±941.38)
Any other information on results incl. tables
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was considered to be a non-sensitiser under the conditions of the test.
The test item did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required
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