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Registration Dossier
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EC number: 700-376-2 | CAS number: 1015689-48-1
- 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
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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:
- 2008-10-02 to 2008-11-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study report
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 429 (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:
- Reaction mass of (3R,3aS,6R,6aS)-6-[(4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoyl)oxy]hexahydrofuro[3,2-b]furane-3-yl 4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoate and (3R,3aR,6R,6aR)-6-(4-(4-(acryloyloxy)benzoyloxy)-3-methoxybenzoyloxy)hexahydrofuro[3,2-b]furan-3-yl 4-(4-(4-(acryloyloxy)benzoyloxy)benzoyloxy)-3-methoxybenzoate + Isomers and (3R,3aR,6R,6aR)-6-(4-(4-(4-(acryloyloxy)benzoyloxy)-3- methoxybenzoyloxy)-3-methoxybenzoyloxy)hexahydrofuro[3,2-b]furan-3-yl 4-(4-(acryloyloxy)benzoyloxy)-3-methoxybenzoate + Isomers
- IUPAC Name:
- Reaction mass of (3R,3aS,6R,6aS)-6-[(4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoyl)oxy]hexahydrofuro[3,2-b]furane-3-yl 4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoate and (3R,3aR,6R,6aR)-6-(4-(4-(acryloyloxy)benzoyloxy)-3-methoxybenzoyloxy)hexahydrofuro[3,2-b]furan-3-yl 4-(4-(4-(acryloyloxy)benzoyloxy)benzoyloxy)-3-methoxybenzoate + Isomers and (3R,3aR,6R,6aR)-6-(4-(4-(4-(acryloyloxy)benzoyloxy)-3- methoxybenzoyloxy)-3-methoxybenzoyloxy)hexahydrofuro[3,2-b]furan-3-yl 4-(4-(acryloyloxy)benzoyloxy)-3-methoxybenzoate + Isomers
- Details on test material:
- Name: 2MeO3-Im4KA2
Batch no.: AC425/428/429/430
Chemical name: (3R,3aS, 6R,6aS)-6-[(4-{[4-(acryloyloxy) benzoyl]oxy}-3-methoxybenzoyl)oxy] hexahydrofuro[3,2-b]furan-3-yl 4-{[4-
(acryloyloxy)benzoyl]oxy}-3- methoxybenzoate
Purpose: industrial chemical
Colour: beige
Physical state: powder
Stability in solution
or suspension: probably stable
Special procedures
for dose preparation: prepare freshly
Storage: at room temperature, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Healthy CBA/J Rj mice, female, age 8 – 12 weeks, 5 mice per test group.
The animals will be derived from a controlled full barrier maintained breeding system (SPF).
Source: Janvier, F - 53940 Le Genest-Saint-Isle
The animals will be barrier maintained (semi-barrier) in an air conditioned room
- Temperature: 22 3 °C
- Rel. humidity: 55 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice - maintenance
- Free access to acidified tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- The animals were kept in IVC cages, type II L, Polysulphone cages on Altromin saw fiber bedding
- Certificates of food, water and bedding are filed at testing facility
- Adequate acclimatisation period (at least 5 days)
Study design: in vivo (LLNA)
- Vehicle:
- other: acetone/olive oil (3:1 v/v)
- Concentration:
- 12,5; 25 and 50%
- No. of animals per dose:
- 5 per group
- Details on study design:
- Topical Application
Each mouse was treated by topical application of 25 μL of the selected solution to the entire dorsal surface of each ear. Topical applications were performed once daily over three consecutive days. Administration of 3H-methyl thymidine Five days after the first topical application treatment all mice were dosed with 20 μCi 3H-methyl thymidine by intravenous injection (tail vein) of 250μL of 3H-methyl thymidine, diluted to a working concentration of 80μCi/mL.
Preparation of cell suspension
Approximately 5 hours after 3H-methyl thymidine-injection all mice were sacrificed. The draining “auricular lymph nodes” were excised and individually pooled for each animal (2 lymph nodes per animal) and collected in phosphate buffered saline (PBS). A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through polyamide gauze (200 mesh size). After washing the gauze with PBS the cell suspension was pelleted in a centrifuge. The supernatant was discarded and the pellets were resuspended with PBS. This washing procedure was repeated. After the final wash each pellet was resuspended in approx. 1 mL 5% TCA at approx. 4 °C overnight for precipitation of macromolecules. Each precipitate was once washed again, resuspended in 1 mL 5% TCA and 5 mL scintillation fluid was added. Then this solution was transferred into scintillation vials and stored at room temperature overnight.
Determination of incorporated 3H-methyl thymidine The 3H-methyl thymidine – incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM). Similarly, background 3H-methyl thymidine levels were also measured (5% TCA). Determination of radioactivity was performed individually for each animal. - Positive control substance(s):
- other: p-Phenylenediamine
- Statistics:
- The proliferative response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (DPM/NODE) and as the ratio of 3H-methyl thymidine - incorporation into lymph node cells of test group animals relative to that recorded for control group animals (STIMULATION INDEX). Before DPM/NODE values were determined, background values were subtracted. EC3 values, calculated concentrations which induce stimulation indices of three, are determined by linear interpolation {EC3=c+[(3-d)/(b-d)]x(a-c)}, between two points of the stimulation indices axis, one above (a,b) and one below (c,d) the stimulation index of three. If all measured points are above or below the stimulation index of three, no EC3 value can be stated. A substance is regarded as a 'sensitizer' in the LLNA if at least one concentration of the test item results in a 3 fold or greater increase in 3H-methyl thymidine - incorporation into lymph node cells of the lymph nodes of the test group animals, relative to that recorded for the lymph nodes of control group animals (Stimulation Index equal to or greater than 3.0).
Results and discussion
- Positive control results:
- The positive test substance worked as expected, the DPM was 10868.8, the stimulation index was 7.0.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index at a concentration of 12.5% was 5.1. The stimulation index at a concentration of 25% was 8.5. The stimulation index at a concentration of 50% was 2.4.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Disintegrations per minute at a concentration of 12.5% were 5728.2. Disintegrations per minute at a concentration of 25% were 9551.4. Disintegrations per minute at a concentration of 50% were 2732.2
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is sensitizing to the skin under the conditions used in this LLNA test.
- Executive summary:
2MeO3 -Im4KA2 wasexamined for beeing a skin sensitizer by means of theLocal Lymph Node Assay (LLNA) according to OECD Guideline 429 on groups of 5 female CBA/J Rj mice. Based on the results of the preliminary test the test item 2MeO3 -Im4KA2
was assayed for sensitising properties at concentrations of 12.5%, 25% and 50% (v/v). The vehicle used was Acetone/Olive Oil (AOO). Each mouse was treated by topical application of the prepared test item to the entire dorsal surface of each ear once daily over three consecutive days. Five days after the first topical application all mice were injected intravenously with 3H-methyl thymidine. Approximately 5 hours after the 3H-methyl thymidine injection all mice were sacrificed. The draining “auricular lymph nodes” were excised. A single cell suspension of the lymph node cells for each animal was prepared. The 3H-methyl thymidine incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM). Determination of radioactivity was performed individually for each animal. The proliferative response of lymph node cells was calculated as the ratio of 3H-methyl thymidine incorporation into lymph node cells of test group animals relative to that recorded for control group animals. A stimulation index, ratio of test item / negative control, was calculated for each concentration. None of the three tested concentrations of the test item reached the stimulation index of 3. The stimulation index at a concentration of 12.5% was 1.0 at a concentration of 25% it was 0.7 and at a concentration of 50% it was 0.6. Weight development of all animals was within the expected range (with the exception of one animal, which lost 3 g), which includes a weight loss of up to 2 g throughout the study. At the daily clinical observation the animals did not show any visible clinical symptoms.The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 4.78 %. Considering the reported data of this sensitisation test it can be stated that the test item 2MeO3 -Im4KA2 causes reactions identified as sensitisation at concentrations of more than 4.78% as they are onsidered to have a stimulation index above 3.0 and are therefore considered to be dermal sensitizers
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