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EC number: 204-798-3 | CAS number: 126-71-6
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- study was conducted before implementation of LLNA
Test material
- Reference substance name:
- Triisobutyl phosphate
- EC Number:
- 204-798-3
- EC Name:
- Triisobutyl phosphate
- Cas Number:
- 126-71-6
- Molecular formula:
- C12H27O4P
- IUPAC Name:
- triisobutyl phosphate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Etingal
- Physical state: liquid, achromatic
- Lot/batch No.: MG-94-37
- Storage condition of test material: room temperature
- Substance number: 94/261
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley Crl: (HA)BR (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH - Wiga, Sulzfeld, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 313 - 388 g
- Housing: No. of animals per cage: 5. Type of cage: Makrolon, type IV. Bedding: Granulat Typ 3/4 (staubfrei); SSNIFF
- Diet (ad libitum): Kliba Labordiät 341 (Kaninchen- Meerschweinchen-Haltungsdiät)
- 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: 8 days before the beginning of the study in the laboratory for dermal toxicity
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70% .
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h light (6.00 a.m. - 6.00 p.m.) 12 h darkness (6.00 p.m. - 6.00 a.m.)
IN-LIFE DATES:
Not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil
- Concentration / amount:
- 75 % / 0.5 mL
- Day(s)/duration:
- 3 times (once per week) for 6 hours, respectively
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil
- Concentration / amount:
- 50 % / 0.5 mL
- Day(s)/duration:
- 6 hours
- No. of animals per dose:
- Pretest: 4
Main test;
- control group: 10
- test group: 20 - Details on study design:
- 2 x 2 cm gauze patches were applied to the skin of the flanks under an occlusive dressing (the bandage consists of rubberized linenpatches 4 x 4 cm
from Russka, test patch of Idealbinde 5 x 5 cm from Pfälzische Verbandstoff-Fabrik, and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG). 0.5 mL of the test substance or test substance preparations were exposed to the animals.
RANGE FINDING TESTS:
Duration of exposure: 6 hours
Site of application: right and left flank
Application frequency: 2 times (one application per week) on the same application area
Number of test animals: 4 per test concentration
Readings: 24 and 48 h after the removal of the patch
Assessment of skin findings: according to Draize, J.H. (1959)
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: anterior left flank
- Frequency of applications: 3 times (one application per week; days 0, 7 and 14) on the same application area
- Concentrations: 75%
B. CHALLENGE EXPOSURE
- Day(s) of challenge: 14 days after the third induction
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: Substance formulation: anterior right flank. Vehicle: posterior right flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch - Challenge controls:
- Treatment of the test group and of control group 1 with the test substance formulation. Additionally olive oil DAB 10 was applied as a vehicle. Control group 2 only received olive oil DAB 10.
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- The positive control showed that the test system was able to detect sensitizing compounds under laboratory conditions chosen.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 9
- Total no. in group:
- 18
- Clinical observations:
- very slight erythema
- Remarks on result:
- other:
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- undiluted
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- No concurrent positive control group. Separate studies were performed twice a year in the laboratory. The results of the latest study are reported.
Applicant's summary and conclusion
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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