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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 609-766-6 | CAS number: 39987-86-5
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Feb to Mar 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- - modified maximization test: an epidermal induction on the scarified skin is performed instead of intracutaneous induction
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
- EC Number:
- 609-766-6
- Cas Number:
- 39987-86-5
- Molecular formula:
- C22 H32 O3
- IUPAC Name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid parrafin
- Concentration / amount:
- intradermal induction: see "Any other information on materials and methods"
topical induction (days 1, 2 and 3): 25 %
topical challenge (days 21 and 28): 25 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid parrafin
- Concentration / amount:
- intradermal induction: see "Any other information on materials and methods"
topical induction (days 1, 2 and 3): 25 %
topical challenge (days 21 and 28): 25 %
- No. of animals per dose:
- control group: 10 (5/sex)
test substance group: 10 (5/sex)
pre-test (local tolerance test, rechallenge control group): 6 (3/sex)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- challenge 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- very slight to slight reddenings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 1.0. Total no. in groups: 9.0. Clinical observations: very slight to slight reddenings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- challenge 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- challenge 25 %
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Clinical observations:
- very slight to slight reddenings
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 2.0. Total no. in groups: 9.0. Clinical observations: very slight to slight reddenings.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- challenge 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- very slight to slight reddenings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: very slight to slight reddenings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- very slight to slight reddenings
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 3.0. Total no. in groups: 6.0. Clinical observations: very slight to slight reddenings.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: none.
Any other information on results incl. tables
One female animal of the test group was found dead on day 2. The animal had possibly died from stress (due to the bandage) during the first induction.
After the first challenge and the rechallenge 1 or 2 of a total of 9 animals showed very slight to slight reddenings on the treated area only 24 hours after the end of challenge. Very slight to slight reddenings each occurred in 3 control animals (first challenge 3/10, rechallenge 3/6).
Applicant's summary and conclusion
- Executive summary:
In a modified guinea pig maximization test (GPMT) according to OECD TG 406 no skin sensitizing potential of the test substance could be observed based on the results after the first challenge and the rechallenge with 25 % ZK 9340.
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.