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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Skin irritation/corrosion
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 May 1992 to 22 May 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: livestock farming
- Age at study initiation: about 2-3 months
- Weight at study initiation: about 2.5 - 3 kg
- Housing: individual caging in air-conditioned rooms. Metal cages measuring 62 x 47.5 x 38 cm.
- 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: about 2 months. Animals were observed daily to ascertain their fitness for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +-2
- Humidity (%): 50 % +- 15
- Air changes (per hr): about 15/ hour
- Photoperiod (hrs dark / hrs light): 12 hour cicle (7 a.m.-7 p.m.)
IN-LIFE DATES: From: To: not reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml /animal
- Concentration (if solution): not applicable
VEHICLE
Test material was applied as supplied by the sponsor. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- Firstly one rabbit was used and three treatment sites were prepared. On the first site the test article was applied for an exposure period of 3 minutes. No serious gross skin reactions are noted and the test article was applied for an exposure period of 1 hour on the second site. The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non.irritant, hypoallergenic tape. No serious gross reactions are observed after the one-hour exposure period and the test article was appliedfor an exposure period of 4 hours on the third skin site. This area was covered with a gauze patch as above. The test was completed using two additional animals with a 4 hour exposure period.
TEST SITE
- Area of exposure: about 6 cm2
- % coverage: occlusive
- Type of wrap if used: gauze patch loosely held in contact with the skin by an impermeable, non.irritant, hypoallergenic tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: the skin reaction was scored according to the following scale:
VALUE ERYTHEMA AND ESCHAR FORMATION
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formatioon (injuries in deoth)
VALUE EDEMA FORMATION
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- same result in all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- same result in all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No dermal modifications were observed in any animal.
- Other effects:
- No animals died.
No clinical signs or behavioral alterations were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions adopted, GALDEN LMW is to be considered "NON IRRITANT" for the skin when administered by dermal route to rabbits.
- Executive summary:
The purpose of the study was to evaluate the acute dermal irritation and/or corrosive effects on skin following the application of the test article GALDEN LMW.
The test method was in accordance with the EEC Guidelines B.4 and with OECD guidelines 404 (Paris 1981, and subsequent revisions).
Three New Zeland White female rabbits were treated with a single application of 0.5 ml of the test article.
Approximately 24 hours before the test, fur was clipped from the trunk of the animals. Care was taken not to abrade the skin. Only animals with intact skin were used.
The test article was applied to a small area (approximately 6 cm2) of skin. Firstly one rabbit was used and three treatment sites of the skin were prepared. On the first site the test article was applied for an exposure period of 3 minutes. No serious gross skin reactions were noted and the test article was applied for an exposure period of 1 hour on the second site. The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape. No serious gross reaction were observed after the one-hour exposure period and the test article was applied for an exposure period of 4 hours on the third skin site. This area was covered with a gauze patch as above. The test was completed using two additional animals with a 4 hour exposure period. At the end of the exposure period, residual test substance was removed, without altering the existing response of the integrity of the epidermis.
Neither deaths occurred as a result of treatment, nor clinical signs or behavioral alterations were observed untoward.
At the application site, no dermal reactions were detected in any rabbit.
The test article GALDEN LMW when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered "NON IRRITANT" for the skin.
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