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EC number: 812-028-8 | CAS number: 612543-60-9
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-12-14 to 2017-02-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010-07-22
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2012-07-06
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-butoxy-4'-(4-ethylphenyl)-2,3,3'-trifluoro-1,1'-biphenyl
- EC Number:
- 812-028-8
- Cas Number:
- 612543-60-9
- Molecular formula:
- C24H23F3O
- IUPAC Name:
- 4-butoxy-4'-(4-ethylphenyl)-2,3,3'-trifluoro-1,1'-biphenyl
- Test material form:
- solid: bulk
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-Source: Envigo RMS B.V., AD Horst, The Netherlands
-Age (beginning of treatment): Pre-test: 8 - 9 weeks, Main study: 9 - 10 weeks
-Weight at study initiation: 17.7 - 21.7 g
-Housing: groupwise in Makrolon Type II/III cages
-Diet: ad libitum
-Water: ad libitum
-Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 22 +/- 2
-Humidity (%): 45 - 65
Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Pre-test for signs of irritation: 5 and 10 % (v/v)
Main study: 0, 2.5, 5 and 10 % (v/v) - No. of animals per dose:
- Pre-test: 2 f
Main study: 5 f per group - Details on study design:
- RANGE FINDING TEST
A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which can be technically used, was a 10% solution in acetone/olive oil (4+1 v/v).
To determine the highest non-irritant test concentration that at the same time did not induce signs of systemic toxicity, a pre-test was performed in two animals. The mice were treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 5 and 10% once daily each on three consecutive days. Prior to the first application of the test item and before sacrifice the body weight was determined. Clinical signs were recorded at least once daily. Eventual signs of local irritation were documented and a score was used to grade a possible erythema of the ear skin. Furthermore, prior to the first application of the test item (day 1), on day 3 and before sacrifice (day 6) the ear thickness was determined using a micrometer. Additionally, for both animals, the ears were punched after sacrifice (day 6) at the apical area using a biopsy punch (Ø 8 mm corresponding to 0.5 cm2) and were immediately pooled per animal and weighed using an analytical balance. Eventual ear irritation was considered to be excessive if an erythema of the ear skin of a score value >= 3 was observed at any observation time and/or if an increase in ear thickness of >= 25 % was recorded on day 3 or day 6.
At the tested concentrations the animals did not show any signs of systemic toxicity. From day 2 to 5, the animals showed an erythema of the ear skin (Score 1). Additionally, the animals showed a slight erythema on the scalp on days 3 and 4 and the animal treated with 10% showed scaly ears on days 5 and 6. No signs of exuberant local skin irritation were observed.
Thus, the test item in the main study was assayed at 2.5, 5, and 10%. The highest concentration tested was the highest level that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed in the pre-experiment.
MAIN STUDYANIMAL ASSIGNMENT AND TREATMENT
-Name of test method: OECD GL 429
-Criteria used to consider a positive response: 3-fold greater response at one concentration in SI than control animals.
TREATMENT PREPARATION AND ADMINISTRATION
Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 2.5, 5, and 10% in acetone/olive oil (4+1 v/v). The application volume (25 μL/ear/day) was spread over the entire dorsal surface of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone.
Determination of Ear Thickness: Prior to the first and third application of the test item (study days 1 and 3) and prior to treatment with 3HTdR (study day 6), the ear thickness was determined using a micrometer.
Administration of 3H-methyl-thymidine: Five days after the first topical application (day 6), 3H-methyl thymidine was injected into each test and control mouse via the tail vein.
Determination of incorporated 3HTdR: Approximately five hours after treatment with 3HTdR all mice were euthanized and the lymph nodes were harvested. The draining lymph nodes were rapidly excised, pooled per animal (2 nodes per animal) and further processed. The level of 3HTdR incorporation was measured in a β-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Standard statistical methods were applied.
Results and discussion
- Positive control results:
- Concentration S.I.
0 % 1.0
5 % 1.5
10 % 3.84
25 % 11.76
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 2.4
- Test group / Remarks:
- 2.5 %
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 5 %
- Key result
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 10 %
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From the data it can be concluded that the test item is not a skin sensitiser under the conditions of this assay.
- Executive summary:
Study Design
In this GLP study performed according to OECD TG 429, three groups each of five female mice were treated once daily with the test item at concentrations of 2.5, 5, and 10% in acetone/olive oil (4+1 v/v) by topical application to the dorsum of each ear for three consecutive days. The highest concentration tested was the highest concentration that could technically be achieved. A control group of five mice was treated with the vehicle (acetone/olive oil (4+1 v/v)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per animal. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.
Results
All treated animals survived the scheduled study period and no signs of systemic toxicity were observed. On day 3 (1h after the third application), an erythema of ear skin was observed (score 1) in the mid and high dose group. On day 4, the high dose group continued to show an erythema of ear skin (score 1). The low dose group did not show any signs of skin irritation. A relevant increase in ear thickness was not observed in any dose group.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Indices of 2.4, 1.8, and 1.6 were determined with the test item at concentrations of 2.5, 5, and 10% in acetone/olive oil (4+1 v/v). The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
Conclusion
The test item was not a skin sensitiser under the test conditions of this study.
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