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EC number: 613-004-8 | CAS number: 62285-89-6
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Magnusson, B. and Kligman, A.M. The Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test. J. Invest. Dermatol. 4, 268 - 276 (1969).
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- [(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride
- EC Number:
- 613-004-8
- Cas Number:
- 62285-89-6
- Molecular formula:
- C28 H32 O2 P . Cl
- IUPAC Name:
- [(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride
- Details on test material:
- - Name of test material (as cited in study report): C5-NPG-ACETAL
- Substance Number: 92/128
- Physical state: white powder
- Analytical purity: 99 %
- Lot/batch No.: 92/33 - 1 (Technikum B 15 S)
- Stability under test conditions: The stability of the test substance in aqua bidest. for at least 4 hours was confirmed by analysis.
- Storage condition of test material: refrigerator; exclusion of moisture
Constituent 1
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, Extertal 1, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 291 - 333 g
- Housing: 5 animals per cage
- Diet (e.g. ad libitum): Kliba Labordiaet 341 (Kaninchen-Meerschweinchen-Haltungsdiaet), Klingentalmuehle AG, Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): Water ad libitum (tap water; about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 1% in 0.9% aqueous NaCl solution resp. in Freund's adjuvant / 0.9% aqueous NaCl solution 1 : 1) resp. 0.9% aqueous NaCl solution.
Percutaneous induction: test substance 25% in aqua bidest.
1st challenge: test substance 10% in aqua bidest.
2nd challenge test substance 10% in aqua bidest.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 1% in 0.9% aqueous NaCl solution resp. in Freund's adjuvant / 0.9% aqueous NaCl solution 1 : 1) resp. 0.9% aqueous NaCl solution.
Percutaneous induction: test substance 25% in aqua bidest.
1st challenge: test substance 10% in aqua bidest.
2nd challenge test substance 10% in aqua bidest.
- No. of animals per dose:
- Pretest: 4
Main test: control group: 5; test group: 10 - Details on study design:
- RANGE FINDING TESTS:
For detecting a possible influence on irritating effects of previous intradermal treatment with Freund's adjuvant, animais pretreated with Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1) each, in the same manner as intradermal induction about 3 weeks prior to the application of the test substance were used.
In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum irritant concentration was found to be a 25% test substance preparation in aqua bidest. and the maximum nonirritant concentration a 10% test substance preparation in aqua bidest. (48 hours after the beginning of application).
Applicability: it was possible to inject a 1% test substance preparation in 0.9% aqueous NaCl solution resp. in Freund's adjuvant / 0.9% aqueous NaC1-solution (1 : 1) with a syringe.
Readings: about 24 and 48 h after the beginning of application
PREPARATION OF THE TEST SUBSTANCE FORMULATIONS
- immediately before test substance application with Ultraturrax or with a magnetic stirrer (only adjuvant preparation)
- Formulations of the test substance were prepared gravimetrically; all concentrations were determined in weight/weight.
MAIN STUDY
A. INDUCTION EXPOSURE
- Form of application: intradermal and percutaneous occlusive
- Skin preparation: Clipping of the test animais: about 3 hours before each test substance application at the appropriate application sites
- Amount applied: 2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing (the bandage consists of rubberized linenpatches 4 x 4 cm and Fixomull(R) Stretch (adhesive fleece). The test filter paper strip was soaked in the test substance formulation; thus, the animais were exposed to about 0.15 g of the test substance formulation.
- No. of exposures: 6 intradermal injections in groups of two per animal
- Exposure period: The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold.
- Test groups:
• Intradermal induction:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant* without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 ml of the test substance formulation
C) back row: 2 injections each of 0.1 ml Freund's adjuvant* / 0.9% aqueous NaCl-solution (1 : 1) with test substance
- Control group:
The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
- Site: shoulder
- Frequency of applications: once
- Concentrations: 1 %
- Readings: about 24 after the beginning of application
• Percutaneous induction:
- Percutaneous induction was carried out one week after intradermal induction
- Amount applied: 2. x 4 cm filter paper strips were soaked in the test substance formulation (about 0.3 g) and applied to the skin of the shoulder under an occlusive dressing (the bandage consists of rubberized linenpatches 4 x 6 cm and Fixomull(R) Stretch (adhesive fleece).
The control animals were not treated since the distilled water used as formulating agent was not expected to influence the result of the study.
- Duration: 48 hours
- Site of application: shoulder, same area as in the case of the previous intradermal application
- Concentrations: 25 %
- Readings: 48 h after the beginning of application
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: First challenge 21 days after intradermal induction. A second challenge was carried out one week after the first one.
- Amount applied: 2 x 2 cm filter paper strips were soaked in the test substance formulation (about 0.15 g of the test substance) and applied to the skin of the flank under an occlusive dressing (the bandage consists of rubberized linenpatches 4 x 4 cm and Fixomull® Stretch (adhesive fleece).
- Exposure period: 24 hours
- Test groups: 1st challenge: treatment of the test group with the test substance formulation
2nd challenge: treatment of the test group with the test substance formulation
- Control group:
1st challenge: treatment of control group 1 with the test substance formulation (control group 2 remained untreated)
2nd challenge: treatment of control groups 1 and 2 with the test substance formulation
- Site: intact flank
- Concentrations: 10 %
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch
OTHER: - Positive control substance(s):
- yes
- Remarks:
- a separate study will be performed twice a year
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- erythema score 2 in 3/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: erythema score 2 in 3/10 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- erythema score 2 in 3/10 animals; edema scor in 1 / 10 animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: erythema score 2 in 3/10 animals; edema scor in 1 / 10 animals.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- erythema score 3 in 2 /10 animals and score 2 in 2 / 10 animals.
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: erythema score 3 in 2 /10 animals and score 2 in 2 / 10 animals..
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- erythema score 2 in 3 / 10 animals
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: erythema score 2 in 3 / 10 animals.
- Reading:
- other: 1st and 2 nd reading as well as rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: 1st and 2 nd reading as well as rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- other: 1st and 2 nd reading as well as rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: 1st and 2 nd reading as well as rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythema and edema.
Any other information on results incl. tables
GPMT
Intradermal induction:
- After intradermal induction well-defined erythema and slight edema were observed at the injection sites of the control group animals and test group animals at which only Freund's adjuvant/0.9% aqueous NaCl solution (1 : 1) was applied.
- Injection of the test substance preparation in 0.9% aqueous NaCl solution as well as in Freund's adjuvant/0.9% aqueous NaCl solution (1 : 1) caused necrotic skin changes and slight edema at almost all injection sites of the test group animals. A few injection sites exhibited well-defined erythema and slight edema.
- The control group animals injected with 0.9% aqueous NaCl solution did not show any skin reaction.
- The percutaneous induction was only carried out in the test group animals, because with aqua bidest. a vehicle was used, that was not expected to influence the result of the study.
- Necrotic skin changes (caused by the intradermal induction) and slight edema were observed.
- After the first challenge (24 hours after removal of the patch) 3 out of 10 animals of the test group showed well defined
erythema. Control group 1 did not show any skin reactions.
- The second challenge caused skin reactions in 4 out of 10 test group animals. Moderate to severe erytherna were observed in 2 animals and well-defined erythema in 2 animals (24 hours after removal of the patch).
- The animals of control groups 1 and 2 did not show any skin reactions.
- The evaluation of the results is based on the criteria of Annex VI/II D of the Council Directive of July 29, 1983 for the 5th Amendment of the Directive 67/548 EEC (= 83/467 EEC)).
- The number of animals sensitized is primarily taken into account in the evaluation. The control animals are used to rule out a substance-induced primary skin irritation.
- The findings obtained 24 hours after the removal of the patch are taken into account for the determination of the sensitization rate.
- The evaluation "sensitizing" has to be made if at least 30 percent of the experiment animals exhibit skin reactions in this adjuvant test.
- The positive control with 1-chlor-2,4-dinitrobenzol showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.
- Based on the results of the study under the test conditions chosen and taking the above cited evaluation criteria into account C5-NPG-Acetal has a sensitizing effect an the skin of the guinea pig in the Maximization Test.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: sensitizing
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