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EC number: 620-097-9 | CAS number: 54299-17-1
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 December 2013 - 05 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- [4-(4-phenoxybenzoyl)phenyl](4-phenoxyphenyl)methanone
- EC Number:
- 620-097-9
- Cas Number:
- 54299-17-1
- Molecular formula:
- C32H22O4
- IUPAC Name:
- [4-(4-phenoxybenzoyl)phenyl](4-phenoxyphenyl)methanone
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: the animals of the preliminary test had a mean body weight of 18.4 g (range: 18.2 g to 18.6 g) and the animals of the main test had a mean body weight of 20.4 g (range: 18.8 g to 22.5 g).
- Fasting period before study: no
- Housing: polycarbonate cages
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: for a period of 6 days before the beginning of the treatment period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: 22 January 2014 to 03 February 2014
Study design: in vivo (LLNA)
- Vehicle:
- other: dimethylformamide (DMF)
- Concentration:
- The maximum concentration tested in the main test was selected according to the criteria specified in the OECD Guidelines and on the basis of the data that was obtained in the preliminary test:
- the vehicle was selected on the basis of producing a homogeneous preparation suitable for application of the test item,
- the concentrations were selected from the concentration series 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5%, etc,
- the maximum concentration of the test item was selected to avoid overt systemic toxicity and excessive local skin irritation the latter being defined by an = 25% increase of the ear thickness. - No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
The maximum concentration tested in the main test was selected according to the criteria specified in the OECD Guidelines and on the basis of the data that was obtained in the preliminary test:
- the vehicle was selected on the basis of producing a homogeneous preparation suitable for application of the test item,
- the concentrations were selected from the concentration series 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5%, etc,
- the maximum concentration of the test item was selected to avoid overt systemic toxicity and excessive local skin irritation the latter being defined by an = 25% increase of the ear thickness.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine Local Lymph Node Assay
- Criteria used to consider a positive response: stimulation Index SI >= 3 and dose-relationship; additional consideration of ear thickness and radioactivity levels.
TREATMENT PREPARATION AND ADMINISTRATION:
- Treatment preparation: The test item was prepared at the chosen concentrations in the vehicle.
The positive control was dissolved in AOO at the concentration of 25% (v/v).
- Administration:
On days 1, 2 and 3, at approximately the same time each day, a dose-volume of 25 µL of the control or dose formulation preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip.
In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration.
No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed. - Positive control substance(s):
- other: a-hexyl cinnamaldehyde (HCA)
Results and discussion
- Positive control results:
- SI = 7.42
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- 50 % EKKE
- Value:
- 1.64
- Key result
- Parameter:
- SI
- Remarks:
- 25% EEKE
- Value:
- 1.15
- Test group / Remarks:
- EKKE
- Key result
- Parameter:
- SI
- Remarks:
- 10% EKKE
- Value:
- 2.05
- Key result
- Parameter:
- SI
- Remarks:
- 5% EKKE
- Value:
- 1.5
- Key result
- Parameter:
- SI
- Remarks:
- 2.5 % EKKE
- Value:
- 1.33
- Key result
- Parameter:
- SI
- Value:
- 7.42
- Test group / Remarks:
- Positive control
Any other information on results incl. tables
The results are presented in the following table:
Treatment |
Concentration (%) |
Irritation level |
Stimulation Index (SI) |
Test item |
2.5 |
I |
1.33 |
Test item |
5 |
I |
1.50 |
Test item |
10 |
I |
2.05 |
Test item |
25 |
I |
1.15 |
Test item |
50 |
I |
1.64 |
HCA |
25 |
- |
7.42 |
-: not recorded.
I: non-irritant (increase in ear thickness < 10%).
HCA: a-hexyl cinnamaldehyde.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- EKKE, tested as a homogeneous suspension at concentrations of 2.5, 5, 10, 25 and 50% in dimethylformamide, gave a negative result in the murine Local Lymph Node Assay, indicative of the absence of skin sensitization properties.
Therefore, the test item should not be classified as a skin sensitizer according to the criteria of CLP Regulation. - Executive summary:
The potential of EKKE to induce contact hypersensitivity was evaluated using the murine Local Lymph Node Assay (LLNA). This study was conducted in compliance with OECD Guideline No. 429 and the principles of Good Laboratory Practices. To assess the irritant potential of the test item (through ear thickness measurement), a preliminary test was first performed in order to define the test item concentrations to be used in the main test. Two groups of two female mice received the test item by topical route to the dorsal surface of both ears (one concentration per ear) on days 1, 2 and 3 at concentrations of 5, 10, 25 or 50% under a dose-volume of 25 µL. From day 1 to day 3 then on day 6, the thickness of both ears of each animal was measured and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6. On completion of the observation period, the animals were sacrificed then discarded without macroscopicpost-mortemexamination. In the main test, five groups of four female mice received the test item by topical route to the dorsal surface of both ears on days 1, 2 and 3 at concentrations of 2.5, 5, 10, 25 or 50% under a dose-volume of 25 µL. One negative control group of four females received the vehicle dimethylformamide (DMF) under the same experimental conditions. Additionally, one positive control group of four females received the positive control,a-hexylcinnamaldehyde (HCA), at 25%in a mixture Acetone/Olive Oil (4/1; v/v)under the same experimental conditions.From day 1 to day 3 then on day 6, the thickness of the left ear of each animal was measured, except in animals of the positive control group, and the local reactions were recorded. Each animal was observed once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6. After 2 days of resting, on day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3H-TdR). Approximately 5 hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of3H-TdR. The results are expressed as disintegrations per minute (dpm) per group and as dpm/node. The obtained values were used to calculate Stimulation Indices (SI).
No unscheduled deaths and no clinical signs were observed during the observation period. Body weight of animals was unaffected by the test item treatment. No local reactions were observed in any animals. In all test item-treated groups, the increase in ear thickness was below 10%. The threshold positive value of 3 for the SI was reached in the positive control group (SI = 7.42). The experiment was therefore considered valid. No significant lymphoproliferation was noted with the test item at any tested concentrations as all SI values were below the cut-off value of 3.
Treatment
Concentration
(%)
Irritation level
Stimulation Index
(SI)
EKKE
2.5
I
1.33
EKKE
5
I
1.50
EKKE
10
I
2.05
EKKE
25
I
1.15
EKKE
50
I
1.64
HCA
25
-
7.42
-: not recorded.
I: non-irritant (increase in ear thickness < 10%).
EKKE gave a negative result in the murine Local Lymph Node Assay, indicative of the absence of skin sensitization properties. Therefore, EKKE not be classified as a skin sensitizer according to the CLP and GHS criteria.
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