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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 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:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Japan, 59 NohSan No. 4200
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified in the report
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-JE874-221 Technical
Lot #: DPX-JE874-221
Purity: 97.4%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson Mill Farm, Jamesburg, New Jersey
- Weight at study initiation: 352 to 475 g
- Housing: One/cage (Stainless steel with elevated wire mesh flooring)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19.4-21.9°C
- Humidity: 39-67%
- Photoperiod: 12 hour light/dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and topical
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- Group I (test article group)
20 animals received six injections (0.05 mL each).
1. Freund's Complete Adjuvant emulsified in deionized water (1:1)
2. 5% v/v dilution of H-20324 in white mineral oil
3. 5% v/v dilution of H-20324 in white mineral oil emulsified with Freund's Complete Adjuvant (1:1)
On Day 8, a 20 mm X 45 mm patch with 0.8 g (0.4 g test article mixed with 0.4 g of white mineral oil) was applied to the intradermal injection area. - Day(s)/duration:
- Day 1 (intradermal) and 8 (topical)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- other: intradermal and topical
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- Group II (test article vehicle control group)
20 animals received six injections (0.05 mL each).
1. Freund’s Complete Adjuvant emulsified in deionized water (1:1)
2. Vehicle Control (white mineral oil) sample alone
3. Vehicle Control (white mineral oil) sample emulsified with Freund’s Complete Adjuvant (1:1)
On Day 8, a 20 mm X 45 mm patch soaked with 0.4 mL white mineral oil was applied to the intradermal injection area. - Day(s)/duration:
- Day 1 (intradermal) and 8 (topical)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- other: intradermal and topical
- Vehicle:
- other: 50% ethanol:saline
- Concentration / amount:
- Group III (Positive control group - DNCB)
6 animals received six injections (0.05 mL each).
1. Freund's Complete Adjuvant emulsified in deionized water (1:1)
2. 0.10% DNCB in 50% ethanol in saline
3. 0.10% DNCB in 50% ethanol: saline emulsified in Freund’s Complete Adjuvant (1:1)
On Day 8, a 20 mm X 45 mm patch soaked with 0.4 mL of 0.10% DNCB in 50% ethanol:saline was applied to the intradermal injection area. - Day(s)/duration:
- Day 1 (intradermal) and 8 (topical)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- other: intradermal and topical
- Vehicle:
- other: 50% ethanol:saline
- Concentration / amount:
- Group IV (Positive control vehicle group)
6 animals received six injections (0.05 mL each).
1. Freund's Complete Adjuvant emulsified in deionized water (1:1)
2. 50% ethanol in saline
3. 50% ethanol: saline emulsified in Freund’s Complete Adjuvant (1:1)
On Day 8, a 20 mm X 45 mm patch soaked with 0.4 mL of 50% ethanol was applied to the intradermal injection area. - Day(s)/duration:
- Day 1 (intradermal) and 8 (topical)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- The 100% level was prepared by mixing equal weights of test article and white mineral oil and applying an amount (0.2 g) containing 0.1 g of test article (100% of dose) to the chamber which was positioned on the left anterior flank. The second level, 0.1 g of a 33% w/w dilution in white mineral oil (1/3 of the challenge dose amount) was applied to a second chamber and positioned on the left posterior flank.
- Day(s)/duration:
- Day 22 (Group I and II)
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- One chamber, soaked with 0.1 mL of acetone, was positioned on the right flank. The remaining two chambers were soaked with 0.1 mL of 0.10% DNCB in acetone and 0.03% DNCB in acetone and were positioned on the left flank, anterior and posterior, respectively.
- Day(s)/duration:
- Day 22 (group III and IV)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Group I: 20 males
Group II: 20 males
Group III: 6 males
Group IV: 6 males - Details on study design:
- RANGE FINDING TESTS:
Irritation screens: The first set of three animals received six injections (0.05 mL each) to each animal, three of these were concentrations of 1, 3 and 5% of the test article in acetone and three concentrations were of the same concentrations in a 1:1 emulsion of Freund's Complete Adjuvant, Since these screens (acetone) were corrosive, additional screens were performed on the second set of three animals, using white mineral oil as the vehicle. The 5% level in white mineral oil appeared to be well-tolerated and was chosen for the main study.
Levels of 100% (0.1 g mixed with 0.1 g of white mineral oil) and 50% (0.05 g mixed with 0.05 g of white mineral oil) were screened to determine the irritation potential of the test article. No skin irritation was noted for either of the 2 test article levels or the vehicle. The 100% level (premixed) was chosen for the challenge phase of this study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: One intradermal injection and a topical application
- Exposure period: 48 h for topical application
- Test groups: Group I (test article group) & Group II (test article vehicle control group)
- Control group: Group III (Positive control group - DNCB) & Group IV (Positive control vehicle group)
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day of challenge: Day 22
- Exposure period: 24 h
- Test groups: Group I (test article group) & Group II (test article vehicle control group)
- Control group: Group III (Positive control group - DNCB) & Group IV (Positive control vehicle group) - Challenge controls:
- The 100% level was prepared by mixing equal weights of test article and white mineral oil and applying an amount (0.2 g) containing 0.1 g of test article (100% of dose) to the chamber which was positioned on the left anterior flank. The second level, 0.1 g of a 33% w/w dilution in white mineral oil (1/3 of the challenge dose amount) was applied to a second chamber and positioned on the left posterior flank.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2, 4-dinitrobenzene (DNCB)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 and 0.03% in acetone
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- Body weight loss was observed in one animal between day 21 and 25.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 and 0.03% in acetone
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- Body weight loss was observed in one animal between day 21 and 25.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 and 33% w/w in white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Body weight loss was observed in one animal between day 7 and 14 and in one animal between day 14 and 21.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 and 33% w/w in white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Body weight loss was observed in one animal between day 7 and 14 and in one animal between day 14 and 21.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 and 33% w/w in white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- One animal was found dead but not related to test article administration. Body weight loss was observed in three animals between day 7 and 14 and in three animals between day 21 and 25.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 and 33% w/w in white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- One animal was found dead but not related to test article administration. Body weight loss was observed in three animals between day 7 and 14 and in three animals between day 21 and 25.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not produce delayed contact hypersensitivity in guinea pigs.
- Executive summary:
The purpose of this study was to determine the potential of the test substance to cause delayed contact hypersensitivity in guinea pigs according to the guidelines OECD 406 and US EPA 81-6. The test substance was moistened with white mineral oil and tested on the clipped, intact skin of male guinea pigs. 1-Chloro-2,4-dinitrobenzene (DNCB) was used to demonstrate the ability of the test system to detect a skin sensitizer (positive control group). A group of male guinea pigs was treated with white mineral oil (vehicle) at induction, and the test substance and white mineral oil at challenge (vehicle control group). In addition, a group of male guinea pigs treated with DNCB at challenge (naive positive control group).
No dermal irritation was observed 24, or 48 hours post-challenge for the test article and vehicle groups at either test article concentration site (100% or 33%) or at the vehicle control site.
The positive control animals exhibited moderate redness at 24 hours after the challenge application and scattered mild redness to moderate redness at 48 hours at the test site challenged with a 0.1% concentration of DNCB. Barely perceptible redness to moderate redness was exhibited in these animals at the 0.03% concentration of DNCB at 24 and 48 hours after the challenge application. No redness was observed 24 or 48 hours after the challenge application of the vehicle (acetone).
No redness was observed at 24, or 48 hours post-challenge for the positive control vehicle animals at the 0.1% and 0.03% concentration of DNCB. No irritation was exhibited by the vehicle (acetone) at 24, or 48 hours post-challenge for these animals.
Under the conditions of this study, the test substance did not produce delayed contact hypersensitivity in guinea pigs.
On the basis of the nature of effects observed in this study and according to the guide for the labeling of dangerous substances published in the Official Journal of the European Communities (EEC Directive 91/325), the test substance is not a skin sensitizer.
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