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EC number: 603-520-1 | CAS number: 131807-57-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Japan, 59 NohSan No. 4200 Testing Guidelines for Toxicity Studies (1985)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-1,3-oxazolidine-2,4-dione
- EC Number:
- 603-520-1
- Cas Number:
- 131807-57-3
- Molecular formula:
- C22H18N2O4
- IUPAC Name:
- 5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-1,3-oxazolidine-2,4-dione
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Substance ID: DPX-JE874
Lot Number: DPX-JE874-221
Purity: 97.28%
Test animals
- Species:
- rabbit
- Strain:
- other: HM:(NZW)fBR New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hare Marland, Hewitt, New Jersey
- Weight at study initiation: 2166 to 3117 g
- Housing: Housed singly in suspended, stainless steel, wire-mesh cages
- Diet: Approximately 125 g/day
- Water: ad libitum
- Acclimation period: 7 or 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1°C
- Humidity: 50 ± 10%
- Photoperiod 12-hour light/12-hour dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- deionozed
- Amount / concentration applied:
- Approximately 0.5 g (moistened with 1 mL of deionized water to form a thick paste)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- The test sites were evaluated and scored according to a numerical scale, approximately 1, 24, 48, and 72 hours after the end of the 4-hour exposure period. One rabbit was further examined at 4
and 7 days after test substance removal. - Number of animals:
- 06 Females
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm2
- Type of wrap if used: Test site is covered with a 2-ply, 1-inch gauze square. The patch was held in place with non-irritating tape. The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test substance in contact with the skin without undue pressure
REMOVAL OF TEST SUBSTANCE
- Washing: Gently washed with warm water to remove excess test substance and gently patted dry.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Approximately 1 hour after removal of the test patches, the test sites were evaluated for erythema, edema, and other evidence of dermal effects and were scored according to the Draize Scale. Additional evaluations were made at approximately 24, 48, and 72 hours after removal of the patches. One rabbit was further examined at 4 and 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Irritant / corrosive response data:
- Two rabbits exhibited no dermal irritation throughout the study. The remaining 4 rabbits
exhibited erythema (score of 1 or 2) at 1 and 24 hours after test substance removal. At 48 hours,
dermal irritation had cleared in 2 rabbits; erythema (score of 1 or 2) was observed in the
remaining 2 rabbits. At 72 hours, dermal irritation had cleared in one rabbit; erythema (score of
2) and desquamation were observed in one rabbit. This rabbit exhibited erythema (score of 1)
and desquamation at 4 days. All dermal irritation cleared in this rabbit by 7 days. No edema,
was observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is classified as Non-Irritant
- Executive summary:
The test substance was evaluated for acute skin irritation potential in 6 female New Zealand White rabbits according to the guidelines OECD 404 and US EPA 81-5. Approximately 0.5 g of the test substance was administered to a localized test site on the back of each animal. The test sites were covered with a semi-occlusive dressing to ensure contact between the skin and test substance. The animals were exposed to the test substance for approximately 4 hours.
The test sites were evaluated and scored according to a numerical scale, approximately 1, 24, 48, and 72 hours after the end of the 4-hour exposure period. One rabbit was further examined at 4 and 7 days after test substance removal.
Two rabbits exhibited no dermal irritation throughout the study. The remaining 4 rabbits exhibited erythema (score of 1 or 2) at 1 and 24 hours after test substance removal. At 48 hours, dermal irritation had cleared in 2 rabbits; erythema (score of 1 or 2) was observed in the remaining 2 rabbits. At 72 hours, dermal irritation had cleared in one rabbit; erythema (score of 2) and desquamation were observed in one rabbit. This rabbit exhibited erythema (score of 1) and desquamation at 4 days. All dermal irritation cleared in this rabbit by 7 days. No edema, significant weight loss, or clinical signs of toxicity were observed during the study.
Mean values erythema scores observed at 24, 48, and 72 hours following exposure are 1.0, 0.5 and 0.33 respectively and the mean edema scores are 0.0, 0.0 and 0.0 respectively.
Based on the overall averages of the mean values calculated for erythema and edema, according to the guide to the labeling of dangerous substances published in the Official Journal of the European Communities (EEC Directive 93/21), Famoxadone can be classified as "NON-IRRITANT" and labeled:
Symbol - None
Risk Phrase - No Risk Phrase
For each of 6 rabbits, the values for both erythema and edema derived at 1, 24, 48, and 72 hours were summed and divided by 4 to obtain a primary dermal irritation score. A Primary Irritation Index (P.I.I.) or average of these 6 individual scores was also calculated. These values are 0.5, 2.0, 1.0. 0.5, 0 and 0 for the individual animals respectively.
According to the guidance provided by the U.S. EPA on data reporting and for toxicity classification and label statements for skin hazards of pesticides, the test substance is considered to be a mild or slight skin irritant (P.I.I. less than 2) and is classified in Toxicity Category IV. This classification is based on the calculated P.I.I. of 0.67 and the presence of erythema (score of 2) at 72 hours.
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.
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