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Diss Factsheets
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EC number: 207-623-9 | CAS number: 485-72-3
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 February - 3 June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7-hydroxy-3-(4-methoxyphenyl)-4-benzopyrone
- EC Number:
- 207-623-9
- EC Name:
- 7-hydroxy-3-(4-methoxyphenyl)-4-benzopyrone
- Cas Number:
- 485-72-3
- Molecular formula:
- C16H12O4
- IUPAC Name:
- 7-hydroxy-3-(4-methoxyphenyl)-4H-chromen-4-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Lot No. of test material: 07-170-FIL-2/3
- Appearance: White powder
- Expiration date: May 2010
- Purity: 98.4%
- Storage condition of test material: Room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nichols Rabbitry Inc., Lumberton, TX
- Age at study initiation: Approx. 13 weeks old
- Weight at study initiation: Males: 2.350 - 2.800 kg; Female: 2.325 kg
- Housing: Suspended, wire bottom, stainless steel cage; 1 animal per cage
- Diet: PMI Feeds Inc. Lab Rabbit Diet #5321; 8 oz daily
- Water: Municipal water supply available ad libitum from automatic water system
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 12 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 12 February 2008 To: 15 February 2008
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.50 mg of test substance (moistened with 0.5 mL water) was applied to the test site
VEHICLE
- Amount applied: Each dose of test substance was moistened with 0.5 mL of deionised water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males and 1 female
- Details on study design:
- TEST SITE
- Area of exposure: The test material was applied to the dorsal surface of the trunk and covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch.
- % coverage: An area was clipped of at least 8 x 8 cm
- Type of wrap: Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopaedic stockinette) which was secured on both edges with strips of tape.
REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test material as possible.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
The test sites were observed for erythema and edema formation and any other dermal defects or irritation at 1, 24, 48 and 72 hours after unwrap.
SCORING SYSTEM: Draize
- Method of calculation:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: All animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- other: All animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: All animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Erythema and edema were not observed at any time throughout the study. No other signs of irritation were observed during the study.
- Other effects:
- - Other adverse local effects: None
- Other adverse systemic effects: None
Any other information on results incl. tables
- Actual temperature: 18 - 22°C
- Actual relative humidity: 41 - 84% (Humidity was outside of the protocol range but did not affect the study outcome)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No evidence of skin irritation or corrosive effects were noted during the study. The primary irritation index obtained from the 1, 24, 48 and 72 hour observations was 0.0. Therefore, Formononetin is considered to be non-irritating to skin.
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