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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 407-830-6 | CAS number: 103335-54-2 DELTA-5-AZA-ACID
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The method used followed that described in the OECD Guidelines for Tesing of Chemicals No. 406 'Skin sensitisation' and Method B6 of 67/548/EEC.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3-oxo-4-azaandrost-5-ene-17β-carboxylic acid
- EC Number:
- 407-830-6
- EC Name:
- 3-oxo-4-azaandrost-5-ene-17β-carboxylic acid
- Cas Number:
- 103335-54-2
- Molecular formula:
- Hill formula: C19H27NO3 CAS formula: C19H27NO3
- IUPAC Name:
- 4a,6a-dimethyl-2-oxo-1H,2H,3H,4H,4aH,4bH,5H,6H,6aH,7H,8H,9H,9aH,9bH,10H-indeno[5,4-f]quinoline-7-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): GR91287X
- Molecular formula (if other than submission substance): C19-H27-N-O3
- Molecular weight (if other than submission substance): 317.43
- Analytical purity: >95%
- Lot/batch No.: CO-0099
- Storage condition of test material: room temp in dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 351-427 kg
- Housing: individually or in pairs in solid floor polypropylene cages with woodflakes
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: min 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 48- 67
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: To: 1995-09-25 - 1995-10-29
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction - 5% w/v
Topical Induction - 50% w/v
Topical challenge - 25% and 10% w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction - 5% w/v
Topical Induction - 50% w/v
Topical challenge - 25% and 10% w/v
- No. of animals per dose:
- 10 control and 20 tested.
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Control group: 3 injections, arachis oil, 50% arachis oil in freund's complete adjuvant with distilled water 1:1 in and freund's complete adjuvant with distilled water 1:1.
- Site: flanks
- Frequency of application: once
- Concentrations: intradermal: 5% w/v in arachis oil, 5% w/v in 1:1 mixture of freund's complete adjuvant plus distilled water and freund's complete adjuvant with distilled water 1:1.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24hrs
- Test groups: 1 (20)
- Control group: 1 (10)
- Site: flanks
- Concentrations: 0.1 -0.2 ml 25% w/w in arachis oil and 10% w/w in arachis oil
- Evaluation (hr after challenge): 24 and 48 hr
OTHER:
Results and discussion
- Positive control results:
- N/A
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% and 10% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Animals No. 11-30: no results for animal 25 (found dead on day 18).
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% and 10% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Animals No. 11-30: no results for animal 25 (found dead on day 18)..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% and 10% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Animals No. 11-30: no results for animal 25 (found dead on day 18).
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% and 10% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Animals No. 11-30: no results for animal 25 (found dead on day 18)..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced 0% (0/19) sensitisation rate and was classified as a non-sensitiser to guinea-pig skin. GR91287X does not require the risk phrase R43 'may cause sensitisation by skin contact' according to EC regulations.
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.