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Diss Factsheets
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EC number: 203-560-6 | CAS number: 108-20-3
- 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:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- -reliability scoring based on 2002 guideline
- Deviations:
- yes
- Remarks:
- During the acclimation period, relative humidity in the animal room was between approximately 20-65% for a maximum of 15 hours.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- During the acclimation period, relative humidity in the animal room was between approximately 20-65% for a maximum of 15 hours.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): diisopropyl ether
- Analytical purity: 99.5%
- Lot/batch No.: 09062392
- Expiration date of the lot/batch: June 2010
- Stability under test conditions: Not reported
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst/The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 17.6 to 22.1 g
- Housing: Single caging in Makrolon Type II with wire mesh top and granulated soft wood bedding
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum (from Harlan Laboratories B.V., 5960 AD Horst/The Netherlands)
- Water (e.g. ad libitum): tap water, ad libitum (Gemeindewerke, 64380 Rossdorf, Germany)
- Acclimation period: at least 5 days prior to the start of the dosing under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 20-65%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, or 100%
- No. of animals per dose:
- 4 females per group
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The highest test item concentration, which can be technically used was 100% of the undiluted test item.
- Irritation: To determine the highest non-irritant test concentration, a pre-test was performed in two animals. Two mice were treated with concentrations of 50 and 100% each on three consecutive days. Clinical signs were recorded within 1 hour and 24 ± 4 hours after each application, as well as on Day 7. At the tested concentrations, the animals did not show any signs of irritation or systemic toxicity.
- Lymph node proliferation response: Not reported.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: a test item is regarded as a sensitizer if (1) the exposure to at least one concentration of the test item resulted in an incorporation of 3-Hmethyl thymidine (3HTdR) at least 3-fold or greater than that recorded in control mice, as indication by the stimulation index, and (2) that the data are comparable with a conventional dose response
TREATMENT PREPARATION AND ADMINISTRATION:
Topical Application - Each test group of mice was treated by a topical (epidermal) application to the dorsal surface of each ear (left and right) with different test item concentrations of 25, 50, or 100% in acetone:olive oil (4:1). The application volume, 25 µl, was spread over the entire dorsal surface of each ear once daily for three consecutive days. A further group was treated with the vehicle alone.
Five days after the first topical application, all mice were administered with 250 µl of 78.3 microCi/ml 3HTdR (corresponds to 19.6 µCi 3HTdR per mouse) by intravenous injection via a tail vein. Approximately 5 hours after treatment with 3HTdR all mice were euthanized buy intraperitonal injection of Pentobarbial-Natrium. The draining lymph nodes were excised and pooled. Single-cell suspensions were prepared and washed with phosphate buffered saline twice and then suspended in 5% tricholoracetic acid. Then the cells were incubated at approximately 4 ºC for 18 hours and the precipatates were resuspended in 5% tricholoracetic acid and transfered to plastic scintillation vials and mixed. The level of 3HtdR incorporation was measured on a beta-scintillation counter as disintegrations per minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- See attached Annex II of study report for positive control results
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 25% group - 0.75 50% group - 0.71 100% group - 0.80
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Control group - 5932 25% group - 4442 50% group - 4242 100% group - 4753
Any other information on results incl. tables
No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. The body weights of animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, Stimulation Indices of 0.75, 0.71, and 0.80 were determined with the test item at concentrations of 25, 50, and 100% in acetone:olive oil (4 +1), respectively. The test item diisopropyl ether was not a skin sensitizer under the test conditions.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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