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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 482-280-8 | 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:
- Experimental Phase: 20 February 2019 to 20 March 2019.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- The relative humidity in the animal room was for a few hours between approximately 13 - 45 % instead of 45 - 65% as stated in the study plan. This deviation to the study plan is not considered to affect the validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 482-280-8
- EC Name:
- -
- Cas Number:
- 449177-94-0
- Molecular formula:
- C8H11F5O2
- IUPAC Name:
- 3-methyl-3-[(2,2,3,3,3-pentafluoropropoxy)methyl]oxetane
- Test material form:
- liquid
- Details on test material:
- Lot No: 2231AM-68E
Expiry date: 01 January 2019
Storage conditions: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Female CBA/Ca (CBA/CaOlaHsd) strain mice were supplied by Envigo RMS B.V, Inc., Postbus 6174, 5960 AD Horst, The Netherlands.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Pre-test: 11 to 12 weeks; Main Test: 9 to 10 weeks
- Weight at study initiation: Not Stated
- Housing: Caged by group in cages with granulated soft wood bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 2°C
- Humidity (%): 45 to 65%
- Photoperiod (hrs dark / hrs light): 12 hours in light, 12 hours in darkness
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Control = vehicle only
Low dose = 25% v/v
Mid dose = 50% v/v
High dose = 100% v/v - No. of animals per dose:
- Four per dose (Plus four for the control)
- Details on study design:
- PRELIMINARY TEST
The systemic toxicity and irritancy potential of the test item was assessed in a preliminary screening test performed using two mice at 50 or 100% v/v test substance respectively. No signs of systemic toxicity were observed; however, very slight erythema of the ear skin was observed in both animals. Additionally, the animal treated with 100% test item concentration showed scaly ears on day 6. No signs of excessive local skin erythema were present in both animals.
Based on this information the undiluted test item and the test item at concentrations of 50% and 25% v/v in acetone/olive oil 4:1 were selected for the main test.
MAIN TEST
Test Item Administration
Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 25% v/v and 50% v/v, in acetone/olive oil (4+1 v/v), and 100% (undiluted). The application volume, 25 µL/ear/day, was spread over the entire dorsal surface (approximately 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals).
Administration of 3H-methyl-thymidine
Five days after the first topical application (day 6) 250 µL of phosphate-buffered saline containing 19.98 µCi of 3H-methyl thymidine (equivalent to 79.9 µCi/mL 3HTdR) were injected into each test and control mouse via the tail vein.
Terminal Procedure
Approximately five hours after treatment with 3HTdR all mice were euthanized by using CO2, which was, after harvesting of the lymph nodes, followed by cervical dislocation to ensure death.
Preparation of Single Cell Suspensions
The draining lymph nodes were rapidly excised and pooled for each experimental group (8 nodes per group). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 µm mesh size). After washing two times 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.
Determination of cellular proliferation (incorporation of 3HTdR)
The precipitates were resuspended in 5 % trichloroacetic acid (1 mL) and transferred to scintillation vials with 10 mL of scintillation liquid and thoroughly mixed. The level of 3HTdR incorporation was then measured in a β-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1 mL aliquots of 5 % trichloroacetic acid. The β-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
OBSERVATIONS
Clinical Observations
All animals were observed on a daily basis, including pre- and post-dose observations on days 1, 2 and 3. Any clinical signs of systemic toxicity, local skin irritation or signs of ill health during the study were recorded.
Determination of Ear Thickness
In the pre-test, the ear thickness was determined prior to the first application of the test item (day 1), on day 3, and on day 6 prior to sacrifice using a micrometre.
Determination of ear weights
In the pre-test, after the lymph nodes have been excised, both ears of mice were punched at the apical area using a biopsy punch (Ø 8 mm corresponding to 0.5 cm2). For each animal both punches were immediately weighed per animal using an analytical balance. The values obtained were taken down manually.
Determination of Body Weights
The body weights were recorded on day 1 (prior to dosing) and prior to sacrifice (pre-test) or prior to treatment with 3HTdR (main experiment). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The postive control (run as a separate study) responded as expected and confirmed the responsiveness of the test system in the laboratory.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.93
- Test group / Remarks:
- 25% v/v test substance
- Key result
- Parameter:
- SI
- Value:
- 0.76
- Test group / Remarks:
- 50% v/v test substance
- Key result
- Parameter:
- SI
- Value:
- 0.66
- Test group / Remarks:
- 100% v/v test substance
Any other information on results incl. tables
There were no deaths on the study. No signs of systemic toxicity were observed during the study period. On day 3, animals treated at all test item concentrations showed a very slight erythema of the ear skin.
Body weight change of the test 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:
- The test item 3-methyl-3-(2,2,3,3,3-pentafluoropropoxy)methyl oxetane was not a skin sensitiser under the test conditions of this study.
- Executive summary:
Introduction
The study was performed to assess the skin sensitisation potential of the test substance in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following guidelines:
-
OECD Guideline for the Testing of
Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay"
(adopted 22 July 2010)
- Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008 (updated 06 July 2012)
Method
Following preliminary screening test animals showed a very slight erythema of the ear skin. No clinical signs of toxicity were noted at a concentration of 100% and this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay.
Three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the test item at 25% and 50%, in acetone/olive oil (4 +1 v/v), and 100% (undiluted). A further group of four animals was treated with acetone/olive oil 4:1 alone.
Results
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. On day 3, animals treated at all test item concentrations showed a very slight erythema of the ear skin.
The Stimulation Indices expressed as the mean radioactive incoporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (%v/v) Stimulation Index Result 25 0.93 Negative 50 0.76 Negative 100 0.66 Negative Conclusion
The test item 3-methyl-3-(2,2,3,3,3-pentafluoropropoxy)methyl oxetane was not a skin sensitiser under the test conditions of this study.
-
OECD Guideline for the Testing of
Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay"
(adopted 22 July 2010)
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.