Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-535-6 | CAS number: 1190931-34-0
- 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 (non-LLNA)
- Remarks:
- Buehler assay
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-11-17 to 2010-03-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler method is a scientifically well-established OECD guideline method and the results revealed by the Bühler test eventually provide a high level of safety relevant to the workers under realistic conditions (LLNA in some cases tends to give false positive results).
Second, the registrant has always been using the Bühler method for skin sensitization testing for similar substances. Therefore, in this particular case the registrant chose to apply the Bühler test for reasons of comparability of the test results with historical testing data obtained for other substances. Finally, as the test item is registered as an intermediate only, there was no regulatory requirement for testing.
Test material
- Reference substance name:
- 2-{[(4R,5R)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4R,5S)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4S,5R)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4S,5S)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol
- EC Number:
- 700-535-6
- Cas Number:
- 1190931-34-0
- Molecular formula:
- C6F6H6O5
- IUPAC Name:
- 2-{[(4R,5R)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4R,5S)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4S,5R)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4S,5S)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): DIOX alcohol
- Substance type: organic mono constituent
- Physical state: Colourless liquid
- Analytical purity: no data
- Lot/batch No.: 107-31
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: Ambient temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco (Lecco), Italy
- Age at study initiation: 4 to 5 weeks old
- Weight at study initiation: 284 to 321 grams
- Housing: Stainless steel cages measuring, with grid floor.
- Diet (e.g. ad libitum): 8GP17, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 15 - 25
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 2009-12-16 To: 2010-01-20
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test item concentration for induction and challenge
- Day(s)/duration:
- 6-hr exposure, once a week for 3 weeks
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test item concentration for induction and challenge
- Day(s)/duration:
- exposure: 6 hours; 1st reading 24h after removal of the dressing; 2nd reading 24h later
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 20
Control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Five animals were used in the preliminary assay to determine the suitable test item concentration; each received 2 concentrations on either flank. The test item was applied at 100, 50, 20, 10 and 5% v/v in sterile water.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: On the day of dosing (Day 1) the hair was clipped from the inductuion site of each animal. Animals of the test group were treated with the undiluted test item. A gauze patch measuring 20x20 mm was soaked with 0.4 ml of the test item and placed onto the selected skin site. All animals of the test group were treated with the test item in this manner and animals of the control group were similarly treated with the selected vehicle (sterile water).
- Control group: see above
- Site: anterior region of the left flank
- Frequency of applications: once weekly
- Duration: 3 weeks
- Concentrations: 100% test item concentration
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 29
- Exposure period: 6 hours
- Test groups: On Day 29, the hair was removed with electric clippers from both the challenge exposure sites of all animals of both test and control groups. A 0.4 ml aliquot of the undiluted test item was spread evenly over an absorbent patch measuring approximately 20x20 mm. This was placed onto the skin of the posterior region of the prepared site on the right flank. A similar patch, containing 0.4 ml of the vehicle selected for the challenge (sterile water), was placed onto the anterior region of the prepared site. All animals of the test and control groups were treated with both the test
item and vehicle in this manner. After an exposure period of approximately 6 hours the dressings were removed and the treated sites cleaned of the remaining test item by washing with lukewarm water.
- Control group: see above
- Site: anterior and posterior regions of the right flank
- Concentrations: 100% test item concentration
- Evaluation (hr after challenge): Approximately 24 hours after removal of the dressing, the treated sites were examined for any signs of reaction to treatment. Skin reaction on the treated sites was again assessed approximately 24 hours after the first examination (approximately 48 hours after removal of the patches). - Challenge controls:
- The undiluted test item was selected for the challenge as no irritation was noted in all main phase animals.
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde in April 2009 was acceptable; 2-Mercaptobenzothiazole in December 2009/January 2010 was not acceptable (0% response); 2-Mercaptobenzothiazole in February 2010 was acceptable (65% response).
Results and discussion
- Positive control results:
- Periodical System Reliability check:
A positive control check using alpha-Hexylcinnamaldehyde was performed on April 2009 and the incidence at challenge was acceptable.
A positive control check using 2-Mercaptobenzothiazole (protocol deviation) was performed on December 2009 to January 2010 and the incidence at challenge (0%) was not acceptable. A second positive control check was performed using 2-Mercaptobenzothiazole on February 2010. The incidence at this third positive control was acceptable (65%).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Negative control valid
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Negative control valid
- Reading:
- other: Periodical test system response check
- Group:
- positive control
- Dose level:
- Induction: 70% alpha-hexylcinnamaldehyde (HCA) in DMSO; challenge: 15% HCA in acetone
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 20% response in test group; 0% in control group. Test system valid.
- Reading:
- other: Periodical test system response check
- Group:
- positive control
- Dose level:
- Induction: 50% 2-mercaptobenzothiazole in DMSO; challenge: 50% 2-mercaptobenzothiazole in corn oil
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 0% response in both test and copntrol groups. Test system regarded as invalid. The assay was repeated.
- Reading:
- other: Periodical test system response check
- Group:
- positive control
- Dose level:
- Induction: 50% 2-mercaptobenzothiazole in DMSO; challenge: 50% 2-mercaptobenzothiazole in corn oil
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 65% response in test group; 0% response in control group at challenge. Test system is valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- These results indicate that the test item does not elicit a sensitisation response in the guinea pig, being there no evidence of response at challenge following a period of induction exposure to the test item, DIOX alcohol.
- Executive summary:
The potential of the test item, DIOX alcohol, to induce and elicit delayed dermal sensitisation was assessed by a guinea pig model using the methods of Buehler. The concentrations of the test item used in the main study were determined on the basis of the results obtained from a preliminary screening test carried out on DIOX alcohol (maximum concentration tested: 100%). The main sensitisation test was undertaken using a test group of 20 animals and a control group of 10 animals. In an attempt to induce sensitisation, test animals were treated by topical application of the undiluted test item. This was repeated at weekly intervals for a total of 3 weeks. Animals of the control group were treated in the same manner but the vehicle alone (sterile water) was used in place of the test item. Two weeks after the third and final induction exposure, animals of the test and control groups were challenged by topical application of both the vehicle alone (sterile water) and the test item at the same concentration used for induction. At challenge no response was observed to the test item, at the selected concentration, in either test or control group animals. No reaction was observed to the vehicle alone (sterile water). These results indicate that the test item does not elicit a sensitisation response in the guinea pig, being there no evidence of response at challenge following a period of induction exposure to the test item, DIOX alcohol.
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.