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EC number: 500-537-5 | CAS number: 161075-00-9
- 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:
- 25 March 1992 to 9 April 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline-conform study conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Hexafluoropropene, oxidized, oligomers, reduced, fluorinated
- EC Number:
- 500-537-5
- EC Name:
- Hexafluoropropene, oxidized, oligomers, reduced, fluorinated
- Cas Number:
- 161075-00-9
- Molecular formula:
- R-O(C3F6O)m-R with R= - CF3, - C2F5, -CF2H
- IUPAC Name:
- 1,1,1,2,3,3-hexafluoro-2,3-bis(1,1,2,2,2-pentafluoroethoxy)propane; 1,1,1,2,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)-3-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)-2-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-{[1,1,1,2,3,3-hexafluoro-3-(trifluoromethoxy)propan-2-yl]oxy}-2-(trifluoromethoxy)propane; 1,1,1,3,3,4,6,6,7,9,9,10,12,12,12-pentadecafluoro-4,7,10-tris(trifluoromethyl)-2,5,8,11-tetraoxadodecane; 1-(difluoromethoxy)-1,1,2,3,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)propane; 2,2,3,5,5,6-hexafluoro-3,6-bis(trifluoromethyl)-1,4-dioxane; 2-(difluoromethoxy)-1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)propane
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Galden HT 70
- Substance type: Pure substance
- Physical state: liquid
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: G 30
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: far from heating sources (volatile)
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: livestock farming
- Age at study initiation: about 7-9 weeks
- Weight at study initiation: males: 225-250 g, females: 200-225 g
- Fasting period before study: 16 hours. Feed was returned to rats three hours after the administration of the test article.
- Housing: 5 animals/sex/cage in air-conditioned rooms. Grill cages. Cage size (cm):40.5 x 38.5 x 18
- Diet (e.g. ad libitum): Certificated pelleted diet, supplied with vitamins and trace elements. Available ad libitum
- Water (e.g. ad libitum): from municipal water main system, filtered and disrtibuted ad libitum.
- Acclimation period: at least 5 days before the strat of the test. Animals were observed daily to ascertain their fitness for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +-2
- Humidity (%): 55 % +- 10
- Air changes (per hr): about 20 hour filtered on HEPA 99.97%.
- Photoperiod (hrs dark / hrs light): 12 hour cicle (7 a.m.-7 p.m.)
IN-LIFE DATES: From: 25-MAR-1992 To: 9-APR-1992
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% methylcellulose 400 cps water solution, containing 0.4% Polysorbate 80.
- Details on oral exposure:
- VEHICLE: no details
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg - Doses:
- 2000 mg/kg
5000 mg/kg - No. of animals per sex per dose:
- 10 (5 males + 5 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observation of clinical signs and mortality were performed after 30 minutes, 2, 4 and 6 hours on the first day after the administration and then twice a day up to the termination of the observastion period.
Body weight was detected twice pre-trial (at randomization and on day 1 just before treatment) and on days 3, 8 and 14.
On day 1 the animals were weighted after a 16-hour fasting.
Volume of administration was based on day 1 body weight.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight, gross pathology at post mortem examination. - Statistics:
- Calculation of LD 50 was not possible.
Results and discussion
- Preliminary study:
- not relevant
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No animals died during the observation period.
- Clinical signs:
- other: Only piloerection was observed in some treated animals starting from 30 minutes and lasting up to 6 hours. Recovery of all animals was achieved within day 2 of the study.
- Gross pathology:
- The autoptic examination performed on animals killed at the end of the study did not show any change.
- Other findings:
- none
Any other information on results incl. tables
CLINICAL SIGNS FREQUENCY (Cumulative)
Table a
No. Rats treated:5 males + 5 females |
|||
Dose: 2000 mg/kg |
|||
Clinical signs |
Number of rats affected |
Signs observed (time) |
|
from |
to |
||
Piloerection |
4 |
30 minutes |
4 hours |
Recovery |
4 |
6 hours |
|
Table b
No. Rats treated:5 males + 5 females |
|||
Dose: 5000 mg/kg |
|||
Clinical signs |
Number of rats affected |
Signs observed (time) |
|
from |
to |
||
Piloerection |
4 |
30 minutes |
6 hours |
Recovery |
4 |
day 2 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental consitions applied in this study, GALDEN LMW showed an LD50 higher than 5000 mg/kg when administered by oral route to rats. Only transient piloerection was noted in some treated animals.
- Executive summary:
The purpose of the study was to evaluate the acute toxicity of the test article GALDEN LMW and to determine the LD 50, its statistical limits and slope, if possible.
The test method was in accordance with OECD guideline 401 (Paris, 1981) and subsequent revisions.
The test article was suspended in 0.5% Methylcellulose 400 cps water solution plus 0.4% Polysorbate 80.
The animals were weighed twice before the trial (at randomization and on day 1 just before treatment) and on day 3, 8 and 14. They were clinically observed for 14 days following administration and killed at the end of the study by excision of the femoral arteries after i.p. overdosage injection of 5% sodium pentobarbital.
A throughout autoptic examination was performed on animals killed at the end of the observation period.
No deaths occurred as consequence of GALDEN LMW oral administration at the dosages applied in this study.
Only piloerection was observed in some animals treated with both dose levels starting from 30 minutes and lasting up to 6 hours.
Recovery of all animals was achieved within 24 hours from treatment.
The body weight gain appeared normal.
At the gross pathology examination no drug-related changes were seen.
In conclusion the test test article GALDEN LMW when administered by oral route to rats under the experimental conditions applied in this study, showed an LD50 higher than 5000 mg/kg.
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