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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 June 2018 - 10 July 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females; nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 167-191 g
- Fasting period before study: Overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing
- Housing: Housed in groups of four in suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet and water: Free access to mains drinking water and food (2014C Teklad Global Rodent diet) was allowed throughout the study.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours of continuous dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
For the purpose of the study, the test item was freshly prepared as a solution in DMSO. DMSO was used because the test item did not dissolve/suspend in distilled water or arachis oil. No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. - Doses:
- In the absence of data relating to the toxicity of the test item, 300 mg/kg was chosen as the starting dose. A single animal was treated at 300 mg/kg which resulted in mortalilty. An additional animal was therefore treated at 50 mg/kg. In the absence of toxicity at a dose level of 50 mg/kg, an additional group of animals were treated.
- No. of animals per sex per dose:
- A total of 5 animals were therefore treated at a dose level of 50 mg/kg.
- Control animals:
- no
- Details on study design:
- - Clinical observations were made 30 minutes, 1, 2 and 4 hours after dosing and then daily for up to 14 days.
- Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
- Morbidity and mortality checks were made twice daily, early and late during normal working days and once daily at weekends and public holidays.
All animals were dosed once by gavage with the volume administered to each animal calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Suffcient time was allowed between each dose group to confirm the survival of the previously dosed animals.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At a dose level of 300 mg/kg, the animal was found dead two days after dosing.
At a dose level of 50 mg/kg, there were no deaths. - Clinical signs:
- other: At a dose level of 300 mg/kg, signs of systemic toxicity noted were hunched posture, pilo-erection and noisy respiration. At a dose level of 50 mg/kg, no signs pf systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities detected in 4 females dosed at 50 mg/kg. In one female at 50 mg/kg, the kidneys were noted as dark.
At the dose level of 300 mg/kg, the macroscopic observations were as follows;
Liver: dark
Kidneys: dark
Stomach: gaseous
Gastric mucosa: hemorrhagic
Non-glandular region: henmorrhagic
Small and large intestine: clear colourless test item present
Any other information on results incl. tables
Table 1 Individual Clinical Observations and Mortality Data - 300 mg/kg
Dose Level (mg/kg) |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
1/2 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
1-0 Female |
H |
H |
H |
0 |
HP Rn |
X |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
H= Hunched posture; P = Pilo-erection; Rn = Noisy respiration; 0= No signs of systemic toxicity; X = Animal found dead; - = No data, animal dead
Table 2 Individual Clinical Observations and Mortality Data - 50 mg/kg
Dose Level (mg/kg) |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
1/2 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
50 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range 50-300 mg/kg body weight (Globally Harmonized Classification System - Category 3).
- Executive summary:
A study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. Following an initial test at dose levels of 300 mg/kg and 50 mg/kg, a further four fasted females was given a single oral dose of test item, as a solution in dimethyl sulfoxide at a dose level of 50 mg/kg body weight. Clinical signs and body weight development were monitored during the study.
The animal treated at a dose level of 300 mg/kg was found dead two days after dosing. No mortality and no signs of systemic toxicity were noted in the animals treated at a dose level of 50 mg/kg.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range 50-300 mg/kg body weight (Globally Harmonized Classification System - Category 3).
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.