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EC number: 210-036-0 | CAS number: 603-35-0
- 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:
- Jan - Feb 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- updated version November 1989
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 1991, before the LLNA OECD TG 429 was in place (adopted in 2002).
Test material
- Reference substance name:
- Triphenylphosphine
- EC Number:
- 210-036-0
- EC Name:
- Triphenylphosphine
- Cas Number:
- 603-35-0
- Molecular formula:
- C18H15P
- IUPAC Name:
- triphenylphosphine
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- - Purity: 99.7%.
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 65-2758.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature.
- Stability under test conditions: Room temperature.
- Solubility and stability of the test substance in the solvent/vehicle: The test substance is stable in the carrier (Olive oil DAB 9) during 4 h . After 5 days the concentration found is significantly lower than the expected one, so that stability of test substance in the carrier can not be stated.
FORM AS APPLIED IN THE TEST (if different from that of starting material): in olive oil DAB 9
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co . KG, 0-W4923 Extertal 1, FRG.
- Females (if applicable) nulliparous and non-pregnant: not specified.
- Weight at study initiation: 282 - 337 g.
- Housing: Makrolon, type IV in fully air-conditioned rooms in which a central air-conditioning.
- Identification of the animals: Ear tag numbering.
- No. of animals per cage: 5.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: At least 7 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C.
- Humidity (%): 30 - 70%.
- Photoperiod (hrs dark / hrs light): 12 h light (6.00 - 18.00 hours) / 12 h darkness (18.00 - 6.00 hours)..
- IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: olive oil DAB 9
- Concentration / amount:
- intradermal induction: 5%,
epicutaneous induction: 10%. - Day(s)/duration:
- intradermal induction: day 0, epicutaneous induction: day 6-8.
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil DAB 9
- Concentration / amount:
- 5%
- Day(s)/duration:
- day 20-21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals per control group: 5
Number of animals of the test group: 10 - Details on study design:
- RANGE FINDING TESTS: yes, dose selection from pretest results. The minimum irritant concentration was determined to be 10 % TPP in olive oil, the maximum non-irritant concentration 5 % in the vehicle (after 2x epicutaneous dosing of 24 h each). The following doses were selected: For intradermal induction 5% TPP in olive oil or in Freund's adjuvant solution. For percutaneous induction 10% TPP in olive oil. For challenge 5% TPP in olive oil.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2.
- Exposure period: intradermal injection, 48 h epicutaneous induction carried out 1 week after intradermal induction.
- Test groups: 1.
- Control group: 2.
- Site: shoulder.
- Frequency of applications: one intradermal and epicutanous each.
- Duration: 48 h epicutanous induction.
- Concentrations: intradermal 5%, epicutaneous 10%.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20-21.
- Exposure period: 24 h.
- Test groups: 1.
- Control groups: 2.
- Site: flank.
- Concentrations: 5%.
- Evaluation (hr after challenge): readings 14h and 48h after removal of the patch. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 1-chlor-2,4-dinitro-benzol
Results and discussion
- Positive control results:
- Under the test conditions chosen 1-chlor-2,4-dinitro-benzol had a sensitizing effect on the skin of the guinea pig strain used.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% in olive oil DAB 9
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- well-defined erythema in 2/10, very slight erythema in 6/10 animals
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reactions.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- severe erythema and distinct edema in 1/10, severe erythema and slight edema in 4/10, distinct erythema in 5/10.
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1: Number of animals with skin findings after the challenge (21 days after intradermal induction) with the test substance
Challenge | ||
5% in olive oil DAB 9 | olive oil DAB 9 | |
Control group 1 | 0/5 | 0/5 |
Control group 2* | no application of test substance | 1/5 |
Test group | 8/10 | 0/10 |
Table 2: Number of animals with skin findings after the challenge (21 days after intradermal induction) with the positive control substance 1-chlor-2,4-dinitro-benzol
Challenge | ||
1% in ethanol | ethanol conc | |
Control group 1 | 0/5 | 0/5 |
Control group 2* | no application of test substance | 0/5 |
Test group | 10/10 | 0/10 |
x/y : number of positive reactions/number of animals tested ; readings 24 h after the removal of the patch
* : Control group 2 that had been intended for a potential. 2nd challenge-was not-needed, since a 2nd challenge was not necessary on the basis of the unambiguous results of the 1st challenge.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the test conditions chosen and following the described results the test substance has a sensitizing effect on the skin of the guinea pig.
- Executive summary:
The test substance was tested for its sensitizing effect on the skin of the guinea pig in the maximization test based on the method of Magnusson and Kligman.
After intradermal induction well-defined erythema and slight edema were observed at the injection sites of the control and test animals at which only Freund's adjuvant/0.9% aqueous NaCl solution (1:1) was applied. Injection of test substance-preparation in olive oil DAB 9 resp. in-Freund'-s adjuvant/0.9% aqueous NaCl solution (1:1) caused well-defined erythema and slight edema in the test animals. The control animals injected with olive oil DAB 9 (vehicle) showed well-defined erythema.
After percutaneous induction incrustation, partially open (caused by the intradermal induction) in addition to well-defined erythema and slight edema could be observed in the test animals. The control animals which were applied with olive oil DAB 9 (vehicle) exhibited well-defined erythema and slight edema.
The percutaneous challenge (24 hours after the removal of the patch) with the 5% test substance preparation in olive oil DAB 9 caused well-defined erythema in 2 out of 10 test animals. Very slight erythema could be observed in 6 out of 10 test animals.
Olive oil DAB 9 applied as a vehicle caused very slight erythema in 1 out of 5 animals of control group 2. The animals of the test group and of control group 1 did not show any skin reactions.
Under the test conditions chosen and following the described results the test substance has a sensitizing effect on the skin of the guinea pig.
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