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EC number: 701-337-2 | CAS number: -
- 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
- Study period:
- 4 October 1988 - 11 November 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD guideline 406 and under GLP conditions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed prior to existance of OECD 429 test guidleine.
Test material
- Reference substance name:
- 3-[(diphenoxyphosphoryl)oxy]phenyl diphenyl phosphate
- EC Number:
- 701-337-2
- Cas Number:
- not available
- Molecular formula:
- C30H24O8P2
- IUPAC Name:
- 3-[(diphenoxyphosphoryl)oxy]phenyl diphenyl phosphate
- Details on test material:
- - Name of test material (as cited in study report): CR 733-S
- Physical state: Liquid
- Lot/batch No.: Confidential information
- Storage condition of test material: At room temperature in the 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: Charles River Wiga, Sulzfeld, FRG
- Age at study initiation: approx. 2 months
- Weight at study initiation: 361-510 g
- Housing: According to guideline
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum, tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 45-75
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction: 2.5%
Epicutaneous induction: 100%
1st Challenge: 10%, 25% and 100%
2nd Challenge: 100%
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction: 2.5%
Epicutaneous induction: 100%
1st Challenge: 10%, 25% and 100%
2nd Challenge: 100%
- No. of animals per dose:
- 10 controls, 20 treated, 5 PIT
- Details on study design:
- RANGE FINDING TESTS:
Non-irritating intradermal injection: 2.5% test article in propylene glycol (non-irritating concentration was chosen, as 5% caused severe necrosis)
Non-irritating epicutaneous application: 100% test article (undiluted)
MAIN STUDY
A. INDUCTION EXPOSURE
According to guideline, but including SDS treatment on day 6.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Day 21 and 28
- Exposure period: 24 hours
- Site:
1. Left flank
2. Right flank
- Concentrations:
1. 100%, 25%, 10% and 0% (w/w)
2. 100%
- Evaluation (hr after challenge): 24 and 48 hours
OTHER
Scoring system according to Kligman, interpretation of results according to classification of Kligman (sensitisation rate) - Challenge controls:
- Not relevant
- Positive control substance(s):
- yes
- Remarks:
- formaldehyde solution (37%) (seperate test)
Results and discussion
- Positive control results:
- A sensitization rate of 90% was obtained at a challenge concentration of 0.5% formaldehyde in Milli-RO water (after 2 times induction with 1% solution).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- other: rechallenge (duplo)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: rechallenge (duplo). . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: rechallenge (duplo)
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: rechallenge (duplo). . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Key result
- Reading:
- other: rechallenge (duplo)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: rechallenge (duplo). . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: rechallenge (duplo)
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: rechallenge (duplo). . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: Formaldhyde solution 37%
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
No positive skin reactions were noted after the induction phase in both the test article and control groups.
After first challenge, a significant amount of animals were find to have positive skin reactions at the 25% and 10% concentration, but not with the undiluted test article:
Hours after reading | ||
Concentration tested | 24 hours | 48 hours |
100% | 0/20 | 0/20 |
25% | 6/20 | 7/20 |
10% | 2/20 | 2/20 |
0% | 0/20 | 1/20 |
Therefore, a second challenge with the undiluted test article (100%) was done (in duplo), which gave no positive reactions in the treatment group and controls.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the second challenge indicates that the substance CR 733-S does not possess sensitising properties. Therefore, it does not need to be classified according to Annex I of 1272/2008/EC (sensitisation rate <30%).
- Executive summary:
This GPMT was performed to determine the sensitising potential of CR 733-S. Study was conducted according to OECD guideline 406 and under GLP conditions. 30 female Dunkin-Hartley guinea pigs were used. Intradermal induction was done with a 2.5% test substance solution (in propylene glycol), undiluted test article was used for epicutaneous induction. First challenge was done with undiluted test article and 25% and 10% solution, second challenge with 100% test article only (in duplo).
No positive skin reactions were noted after the induction phase in both the test article and control groups. After first challenge, a significant amount of animals were find to have positive skin reactions at the 25% and 10% concentration, but not with the undiluted test article. Therefore, a second challenge with the undiluted test article (100%) was done (in duplo). No clear positive reactions were noted in the test article or control group after the second challenge.
Under the conditions of this study, the second challenge indicates that the substance CR 733-S does not possess sensitising properties. Therefore, it does not need to be classified according to Annex I of 1272/2008/EC (sensitisation rate <30%).
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