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EC number: 250-709-6 | CAS number: 31570-04-4
- 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:
- 1979-05-28 - 1979-07-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Light period of 10 hours light. incomplete series of induction in test and control groups.
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. Guinea Pig optimization tests like the Maurer optimization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines.
Test material
- Reference substance name:
- Tris(2,4-ditert-butylphenyl) phosphite
- EC Number:
- 250-709-6
- EC Name:
- Tris(2,4-ditert-butylphenyl) phosphite
- Cas Number:
- 31570-04-4
- Molecular formula:
- C42H63O3P
- IUPAC Name:
- tris(2,4-ditert-butylphenyl) phosphite
- Details on test material:
- - Substance type: organic
- Physical state: solid, white powder
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: Bantin and Kingman Ltd. Grimston, Hull, England
- Weight at study initiation: 380 - 500 g
- Housing: individually in Macrolon cages, type 3
- Diet (e.g. ad libitum): ad libitum, standard guinea pig pellets (NAFAG, No. 830, Gossau SG)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- on Day 35, duration 24h
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- On day 45; duration 24h
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: -
- Test groups: test substance + vehicle (first week) and test substance + vehicle:FCA (1:1) (second and third week)
- Control group: vehicle
- Site: right flank and back
- Frequency of applications: every second day (except weekends)
- Duration: 0-21 d- Concentrations: 0.1 %
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 35 and 45
- Exposure period: -
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24 - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- one animal (male) died
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 10
- Total no. in group:
- 19
- Clinical observations:
- one animal (male) died
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Clinical observations:
- one animal (female) died
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The test substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.
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