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EC number: 411-380-6 | CAS number: 147315-50-2 CG 30-1577
- 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
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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 - 1992-11-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The GPMT has been carried out as an animal test to predict human sensitisation for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol
- EC Number:
- 411-380-6
- EC Name:
- 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol
- Cas Number:
- 147315-50-2
- Molecular formula:
- C27 H27 N3 O2
- IUPAC Name:
- 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production, Stein, Switzerland
- Age at study initiation: young adult based on body weight range
- Weight at study initiation: 334 to 414 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 1992-09-07 To: 1992-10-08
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- Intradermal induction exposure: 5%
Epicutaneous induction and epicutaneous challenge exposure (based on pretest results): 40%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Intradermal induction exposure: 5%
Epicutaneous induction and epicutaneous challenge exposure (based on pretest results): 40%
- No. of animals per dose:
- Pretest: 6 animals (3 males, 3 females)
Main test: 20 test animals (10 males, 10 females), 10 control animals (5 males, 5 females), - Details on study design:
- RANGE FINDING TESTS:
A pretest was performed to identify appropriate test item concentrations for induction and challenge in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 exposures, i.e. a single intradermal exposure in week 1 (6 injections/animal) and an epicutaneous exposure in week 2 (closed patch)
- Exposure period: single application (intradermal exposure), 48 hours (epicutaneous exposure)
- Test group: 1 group of 20 animals
- Control group: 1 group of 10 animals
- Site: neck region
- Frequency of applications: 1 intradermal application (week 1) and 1 epicutaneous application (week 2)
- Concentrations: 5 % (intradermal exposure), 40 % (epicutaneous exposure)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 epicutaneous exposure
- Day of challenge: in week 5 of the study period
- Exposure period: 24 hours
- Test group: 1 group of 20 animals
- Control group: 1 group of 10 animals
- Site: neck region
- Concentration: 40 % (epicutaneous exposure)
- Evaluation: approximately 24 and 48 hours after removal of the dressing
OTHER:
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. - Challenge controls:
- No evident positive reactions were noted after the first challenge application, neither when treated with vaseline alone nor when treated with a 40% test substance dilution.
- Positive control substance(s):
- yes
- Remarks:
- Potassiumdichromate, for the induction period a 0.20 % dilution in physiological saline (intradermal induction) and 5 % preparation in vaseline (for epidermal induction) was used. For the challenge procedure a 1 % preparation in vaseline was used.
Results and discussion
- Positive control results:
- A positive control with a known sensitizer produced the expected rate of sensitization reactions and demonstrated the sensitivity of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a dermal sensitisation study with the test item (as described in section 1.2) in Oleum arachidis (intradermal induction) or in vaseline (epicutaneous applications), young adult guinea pigs (test group: 10 males and 10 females, control group: 5 males and 5 females) were tested using the guinea pig maximisation test of Magnusson and Kligman. In this study, the test group animals received 5 % of the test item for intradermal induction in week 1 as well as 40 % (highest non-irritant concentration) of the test item for epicutaneous induction in week 2 and challenge in week 5. Concurrent negative control animals were treated similarly, except that during the induction phase the test item was omitted. No animal of the test group was sensitised by the test item under the experimental condition employed. Under the conditions of this study, the test item was not a skin sensitiser.
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