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EC number: 700-579-6 | CAS number: -
- 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:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- When the test was performed in 2008, the OECD N°429 (LLNA method) was not adopted yet.
Test material
- Reference substance name:
- tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) 2-(dodecan-5-yl)-4-(4-sulfonatophenoxy)benzene-1-sulfonate 2-(dodecan-5-yl)-4-[3-(dodecan-5-yl)-4-sulfonatophenoxy]benzene-1-sulfonate
- EC Number:
- 700-579-6
- Molecular formula:
- C90H114O7S2N6 (MW = 1454) and C102H138O7S2N6 (MW = 1622)
- IUPAC Name:
- tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) 2-(dodecan-5-yl)-4-(4-sulfonatophenoxy)benzene-1-sulfonate 2-(dodecan-5-yl)-4-[3-(dodecan-5-yl)-4-sulfonatophenoxy]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: S.C.E.A du Peycher (24610 Villefranche, France)
- Weight at study initiation: less or equal to 500 g
- Housing: 1 animal per cage. Polypropylene cage (31 cm x 46 cm x 19 cm)
- Diet : granules 106 (supplied by SAFE (89290 Augy, France))
- Water : ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): RH : 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 60% of the test material in olive oil
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 60% of the test material in olive oil
- No. of animals per dose:
- 20 for the test group
10 for the control group
And 2 animals for determining the maximum non-irritating concentration - Details on study design:
- RANGE FINDING TESTS:
2 animals were used.
Maximal irritating concentration was determined to be 60 % in olive oil
Maximum Non-irritating Concentration was determined to be 60 % in olive oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 29 days
- Test groups: 20
- Control group: 10
- Site: scapular area
- Duration: 6 hours
- Concentrations: 60 %
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on the 29th day
- Exposure period:2 days
- Site: lombar dorsal area
- Test groups: 0.50 mL of the test item at the maximum non-irritating concentration (60%) et at half maximum non-irritating concentration (30%)
- Control group: 0.50 mL of the vehicle
- Concentrations:30% and 60%
- Evaluation (hr after challenge): 1 day and 2 days after - Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylcinnamaldehyde (CAS # 101-86-0)
Results and discussion
- Positive control results:
- 50% of animals were positive with hexylcinnamaldehyde
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 and 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- na
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 and 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: na.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- negative control, no test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- na
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: na.
Any other information on results incl. tables
Maximal irritating concentration was determined to be 60 % in olive oil
Maximum Non-irritating Concentration was determined to be 60 % in olive oil
vehicle : olive oil
Animal’s number |
Skin reaction as a function of time and concentration |
|||||
60% |
30% |
15% |
7.5% |
Vehicle |
||
3824 |
1h |
0 |
0 |
0 |
0 |
0 |
24h |
0 |
0 |
0 |
0 |
0 |
|
48h |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
3859 |
1h |
0 |
0 |
0 |
0 |
0 |
24h |
0 |
0 |
0 |
0 |
0 |
|
48h |
0 |
0 |
0 |
0 |
0 |
0: no visible modification
Weight of a animals were recorded for controls and tested groups. No difference was noticed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test element at the concentration of 60 % in olive oil was not classified among the chemicals which may cause sensitization by skin contact.
- Executive summary:
The aim of the study was to assess, in 30 guinea-pigs, the sensitisation potential of the test element under occlusive patch.
The assay has been performed according to the OECD guideline N° 406.
The 20 treated animals were exposed 3 times to the test element by epidermal application at the concentration of 60% with olive oil.
Concurrently, the 10 control animals received olive oil by epidermal application. Following a rest period of 14 days ending the induction period, all the animals were exposed to the non irritant challenge of 60 % with olive oil.
The extent, degree and duration of skin reaction to the challenge exposure in the test animals were compared with those demonstrated by control animals.
The percentage of reactive control and treated animals was of 0%.
The test element at the concentration of 60 % in olive oil was not classified among the chemicals which may cause sensitization by skin contact.
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