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EC number: 443-930-6 | 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-03-01 to 2006-03-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 443-930-6
- EC Name:
- -
- Cas Number:
- 866594-60-7
- Molecular formula:
- C7H10O4
- IUPAC Name:
- (3AS,4S,6AR)-4-METHOXYTETRAHYDROFURO[3,4- B]FURAN-2(3H)-ONE
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TIC2782 (T002907)
- Substance type: white solid
- Physical state: solid
- Analytical purity: 99.9%
- Purity test date: no data
- Lot/batch No.: 00467090 ( = charge 05C0836)
- Expiration date of the lot/batch: 2006-05-04
- Stability of test item: stable under storage conditions
- Storage condition of test material: at room temperature (range of 20 +/- 5 °C), light protected
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Remarks:
- CaHsdRcc(SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: 16 female (+ 3 females for pretest (non-GLP)) mice, CBA/CaHsdRcc (SPF) (nulliparous and non-pregnant); RCC Ltd, Laboratory Animal Servive, CH-4414 Füllinsdorf, Switzerland
- Age at beginning of acclimatization: 8-12 weeks
- Weight at treatment (day 1): 17.0 -21.3 grams
- Housing: Standard Laboratory Conditions; individual in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum):ad libitum, pelleted standard Kliba 3433, batch no. 76/05 mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst).
- Water (e.g. ad libitum): ad libitum, community tap water from Itingen
- Acclimation period: at least 6 days, under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light/12 hour dark cycle with at least 8 hours music during the light period
IN-LIFE DATES: From: 2006-03-08 To: 2006-03-13
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0, 10, 25 and 50% (w/v)
- No. of animals per dose:
- 4 females per group; 3 test groups and 1 negative control group
- Details on study design:
- RANGE FINDING TESTS:
- In non-GLP solubility pretest, the test item was tested in different vehicles: acetone/olive oil (4/1, v/v), ethanol/water (7/3, v/v) and N,N-dimethylformamide (DMF). N,N-dimethylformamide (DMF) was found to be a suitable vehicle and was selected and used in the main test. 50 % was the highest technically applicable concentration in the chosen vehicle.
- A non-GLP local toxicity pre-test was performed for determination of concentrations for the main test. Three single animals were each treated with one of three different concentrations: 10 %, 25 % and 50 %, in both ears on three consecutive days. No clinical signs were observed at these concentrations one day after each single application. One day after the third topical application, the residual test item was found at the dosing sites of 50 %.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with the test item at concentrations of 10 %, 25 % and 50 % in DMF. The application volume, 25 μl, was spread over the entire dorsal surface (diameter ~ 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
- Criteria used to consider a positive response: a test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled: first, exposure to at least one concentration of the test item resulted in an incorporation of ³HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the S.I.; second, the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
ADMINISTRATION OF ³HTdR
- Five days after the first topical application, all mice were administered with 250 μl of PBS (phosphate buffered saline) containing 78.37 μCi/ml 3HTdR (equal to 19.6 μCi 3HTdR) by intravenous injection via a tail vein.
DETERMINATION OF INCORPORATED ³HTdR
- Approximately five hours after treatment with 3HTdR all mice were euthanized by inhalation of CO2 (dry ice).
- The draining lymph nodes were rapidly excised and pooled for each experimental group (8 nodes per group). Single cell suspensions (phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 μm mesh size). After washing twice with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to glass scintillation vials with 10 ml of ‘Irga-Safe Plus’ scintillation liquid and thoroughly mixed.
- The level of 3HTdR incorporation was then measured on a β-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1ml-aliquots of 5 % trichloroacetic acid. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated for the body weights.
Results and discussion
- Positive control results:
- Stimulation indices of 1.8, 2.9 and 6.2 were determined with the test item at concentrations of 5%, 10% and 25%, respectively, in acetone:olive oil, 4:1 (v/v).
Alpha-hexylcinnamaldehyde was therefore found to be a skin sensitizer in the LLNA test and an EC3 value of 10.5% was derived.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 10% w/v group (based on results of 4 animals)
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 25% w/v group (based on results of 4 animals)
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 50% w/v group (based on results of 4 animals)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
control group: 351 dpm per node (8 lymph nodes in total)
10% w/v group: 257 dpm per node (8 lymph nodes in total)
25% w/v group: 441 dpm per node (8 lymph nodes in total)
50% w/v group: 322 dpm per node (8 lymph nodes in total)
DETAILS ON STIMULATION INDEX CALCULATION
see Results
EC3 CALCULATION : no EC3 value could be calculated as the SI values for all groups were below 3
CLINICAL OBSERVATIONS:
No deaths occurred during the study period.
Neither clinical/local signs nor other findings were observed in any animals of the control group or Group 2 (10%). On the second application day, the residual test item was found at all the dosing sites in all mice of Groups 3-4, persisting for a total of two days.
No findings were observed on the size of the draining lymph nodes.
BODY WEIGHTS
The body weight of the animals, recorded prior to the first application and prior to necropsy, was within the range commonly recorded for animals of the strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study S.I. of 0.7, 1.3 and 0.9 were determined with the test item at concentrations of 10 %, 25 % and 50 %, respectively, in DMF.
TIC2782 (T002907) was therefore found to be a non-sensitizer when tested up to the highest applicable concentration of 50 % in DMF.
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