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EC number: 416-140-4 | CAS number: 145650-60-8 IRGAFOS 38
- 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:
- 1992-08-11 to 1993-01-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (OECD Guideline 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted on 17-Jul-1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- EC Number:
- 416-140-4
- EC Name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- Cas Number:
- 145650-60-8
- Molecular formula:
- C32H51 O3 P
- IUPAC Name:
- bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite
- Details on test material:
- Physical properties: Solid, white
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 323 to 423 g
- Housing: individually in Macrolon cages
- Diet: ad libitum standard guinea pig pellets
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: 30 to 70%
- Photoperiod: 12 hrs light cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline, arachis oil, physiol. saline
- Concentration / amount:
- Intradermal Induction: test substance in arachis oil and adjuvant mixture: 5%
Epidermal Induction: test substance 50 % in vaseline
Epidermal Challenge: test substance 50 % in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline, arachis oil, physiol. saline
- Concentration / amount:
- Intradermal Induction: test substance in arachis oil and adjuvant mixture: 5%
Epidermal Induction: test substance 50 % in vaseline
Epidermal Challenge: test substance 50 % in vaseline
- No. of animals per dose:
- test group: 10 male and 10 female guinea pigs
control group: 5 male and 5 female guinea pigs - Details on study design:
- RANGE FINDING TESTS
The concentration of the test compound for the induction and challenge periods were determined on four separate animals with concentrations of 1 %, 5 %, 10 %, 20%, 30% and 50%. The tested concentrations did not induce erythema reactions, therefore a concentration of 50% in vaseline was selected. No skin irritation was observed in the pretest. Therefore the application site was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. Concentration of test article for challenge was also 50% in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two-stage operation
- Exposure period: weeks 1 and 2
- Site: First, three pairs of intradermal injections into the neck region (adjuvant/saline; test item in vehicle; test item in vehicle plus adjuvant/saline) were given. Second, closed patch exposure over the injection sites one week later.
During weeks 3 and 4 no treatments were performed.
B. CHALLENGE EXPOSURE
- Exposure period: week 5
- Test and control groups: test substance in vaseline (w/w)
- Site: on the flank (occluded administration for 24 hrs) - Challenge controls:
- A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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