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EC number: 917-631-0 | 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26-MAR-1999 to 30-OCT-2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The concentrations of substance in the atmosphere were not determined (nominal concentrations).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was not designed to be in compliance with any particular guideline. The data were initially generated for internal use. However the method is consistent with standardised methods.
- GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- [2-Chloro-1,2,2-trifluoro-1-(trifluoromethyl)ethoxy] difluoroacetyl fluoride
- EC Number:
- 917-631-0
- Molecular formula:
- C5ClF9O2 and C5F10O2
- IUPAC Name:
- [2-Chloro-1,2,2-trifluoro-1-(trifluoromethyl)ethoxy] difluoroacetyl fluoride
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited (Margate, Kent / ENGLAND)
- Age at study initiation: 7 and 8 weeks old for males and females, respectively
- Weight at study initiation, fasting period before study: no data available
- Housing: by sex in groups of 5, in holding cages (size 35 cm x 53 cm x 25 cm height)
- Diet: ad libitum (except during the 4-h exposure), excess amount of SDS rat and mouse diet (RM1)
- Water: ad libitum (except during the 4-h exposure), tap water
- Acclimation period: at least 5 days before the day of exposure
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 26°C
- Humidity: 45 to 63%
- Air changes: 12 to 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light (artificial light between 07:30 - 19:30 daily)
IN-LIFE DATES: from 15-APR-1999 to 22-Jul-1999
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the vapour generator was designed to produce an atmosphere containing vapour by evaporation of the test substance from a fritted glass disc with a countercurrent of air. All parts of the generator in contact with the test substance were made of glass. The test substance was delivered to the generator at a constant flow rate from a syringe driven by a syringe pump and the air supplied to the generator was dried, filtered and oil free. The snout-only exposure chamber used for the exposures was of cylindrical form (30 cm i.d., 45 cm height) and made of aluminium alloy. The rats were held for exposure in (separate) moulded polycarbonate restraining tubes which were attached at evenly spaced ports in the cylindrical section of the chamber. The conditioned test atmosphere entered through a port at the top centre of the chamber and passed out through a port at the base section below the level of the rats.
- Exposure chamber volume: the chambers have an enclosed volume of approximately 30 litres.
- Method of holding animals in test chamber: each rat was restrained in a forward position by an adjustable foamed plastic stopper.
- Source and rate of air: clean dried air at a flow rate of 20 L/min
- Method of conditioning air: no data available
- System of generating test atmosphere: a syringe filled with the test substance was fitted to the syringe pump and connected to the generator with Teflon tubing. The syringe was switched on and the exposure timed for 4 h, following a 5-min equilibration period. The syringe was replaced with a filled syringe as required during the exposure. After 4 h, the syringe pump was switched off and the exposure chamber allowed to clear before rats were removed for examination.
- Treatment of exhaust air: no data available
- Temperature in air chamber: 19.6 to 20.8°C
- Humidity, pressure in air chamber: no data available
TEST ATMOSPHERE
The nominal concentration of the test substance was calculated from the amount of test item delivered to the vapouriser and the total volume of air flowing through the exposure system during the period of generation.
VEHICLE
Not applicable - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- Target concentrations: 1, 5, and 2.5 mg/L for groups 1, 2 and 3, respectively
- No. of animals per sex per dose:
- 5 per sex and per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rats were observed continuously fir signs of reaction to the test substance during exposure and at least twice daily throughout the observation period. The clinical signs were recorded prior to the end of the chamber equilibration period, 0.25, 0.5 and 1 h into exposure, then at hourly intervals during the remainder of the exposure. Signs were also recorded immediately after exposure and at 1 and 2 h after exposure. During the 14-d observation period, the clinical signs were recorded once in the morning and then as necessary following later check for clinical signs. All rats were weighed twice during the week prior to exposure, at time 0 (immediately before exposure) and weekly during the observation period.
- Necropsy of survivors performed: yes; all rats were subjected to a detailed macroscopic examination. The lungs (including the larynx and trachea), liver and kidneys were dissected free of surrounding tissue, weighed and the weights recorded. The heads from group 2 rats and one decedent group 3 rat were preserved in neutral buffered formalin. The remaining tissues were then discarded.
- Other examinations performed: the amount of food consumed by each cage of rats was measured from weighday to weighday throughout the study. Moreover, a visual inspection of water bottles was conducted daily. - Statistics:
- LD50 was not calculated.
Results and discussion
- Preliminary study:
- Prior to the exposure of group 1, single rats were exposed to nominal concentrations of 0.088, 0.62 and 1.17 mg/L in order to confirm the survivability of rats up to concentrations of approximately 1 mg/L which is the LC50 for hydrofluoric acid.
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 1.17 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: approximate LC50
- Effect level:
- > 2.66 - < 5.37 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- Four males and one female from group 2 were found dead in the cage on day 1 of the observation period. Two further females from group 2 were found dead in the holding cage, one each on days 2 and 3 of the observation period. Severe lung congestion was seen in all of these animals. One male of group 3 was found in a moribund condition on day 4 of the observation period (see in Table 2).
- Clinical signs:
- other: During the exposure, exaggerated breathing was seen in all groups. During the observation period, treatment-related observations included signs of respiratory distress in all groups, lethargy, hunched posture and staggering in rats of groups 2 and 3 and p
- Body weight:
- A treatment-related reduction in bodyweight gain was seen in surviving rats over the observation period (see in Table 3).
- Gross pathology:
- At the end of the 14-d observation period, pale areas and minimal or moderate congestion was seen in the lungs from surviving rats.
- Other findings:
- - Organ weights: at the end of the 14-d observation period, no treatment-related effect was seen in surviving rats.
- Food and water consumption: food consumption was reduced concomitant with reduced weight gain. Measurement of water consumption by group 2 was commenced on the day after exposure following gross observation of low consumption. From day 3 of the observation period, water consumption was considered to be normal.
Any other information on results incl. tables
Table 2: Mortality
Group (nominal concentration - mg/L) |
Mortality |
|
|
|
Males |
Females |
Total |
1 (1.17) |
0/5 |
0/5 |
0/10 |
2 (5.37) |
4/5 |
3/5 |
7/10 |
3 (2.66) |
1/5 |
0/5 |
1/10 |
Table 3: Group mean bodyweights (g)
Group (nominal concentration - mg/L) |
Day of observation |
|
|
|
|
|
|
|
-6 |
-5 |
-3 |
-2 |
0 |
7 |
14 |
1 (1.17) Males Females |
228 198 |
|
255 204 |
|
273 209 |
300 228 |
338 242 |
2 (5.37) Males Females |
|
230 198 |
|
256 209 |
274 212 |
285 195 |
Death 236 |
3 (2.66) Males Females |
278 213 |
|
293 216 |
|
310 224 |
306 229 |
354 244 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- In this study, the non-lethal exposure level was a nominal concentration of 1.17 mg/L.
- Executive summary:
The acute inhalation toxicity of the test item was investigated in compliance with GLP.
Groups of 5 male and 5 female albino rats (Sprague-Dawley in origin) were exposed by nose-only inhalation to a vapour of the test substance in clean dried air at the (calculated) nominal concentrations of 1.17, 2.66 and 5.37 mg/L for a single 4-hour period. Concentrations of test substance in the test atmospheres were not determined. The exposure levels were estimated from test substance usage and were nominal concentrations only. Following exposure, animals were retained without treatment for 14 days. Clinical observations and body weights were recorded throughout the study and at the end of the 14-d observation period. Animals were then killed and given a gross examination post-mortem.
Four males and one female from group 2 (i.e., 5.37 mg/L) were found dead in the cage on day 1 of the observation period. Two further females from group 2 were found dead in the holding cage, one each on days 2 and 3 of the observation period. Severe lung congestion was seen in all of these animals. One male of group 3 (i.e., 2.66 mg/L) was found in a moribund condition on day 4 of the observation period. No death occurred in the group 1 (i.e., 1.17 mg/L).
During the exposure, exaggerated breathing was seen in all groups. During the observation period, treatment-related observations included signs of respiratory distress in all groups, lethargy, hunched posture and staggering in rats of groups 2 and 3 and partially closed eyes and whole-body tremors in group 2 only.
Moreover, a treatment-related reduction in bodyweight gain was seen in surviving rats over the observation period.
At the end of the 14-d observation period, pale areas and minimal or moderate congestion was seen in the lungs from surviving rats but no treatment-related effect on organ weight was seen in surviving rats.
Under the conditions of this study, the non-lethal exposure level (LC0) was a nominal concentration of 1.17 mg/L for male and female rats. Given the number of deaths observed at the concentrations tested (from 1/10 to 7/10), the LC50 of the test substance should be between 2.66 and 5.37 mg/L and therefore the test substance is classified as Acute Toxicity Category 3 (H331) according to the classification criteria of Regulation (EC) No. 1272/2008 (CLP / EU GHS) and UN GHS.
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