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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-812-1 | CAS number: 1189052-95-6
- 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 / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Arrival of the Test Item: 16 June 2011 Date of Draft Study Plan: 27 June 2011 Date of Final Study Plan: 28 June 2011 Start of Experiment: 29 June 2011 End of Experiment: 01 July 2011 Date of Draft Report: 08 July 2011 Date of Final Report: 21 July 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Principles of method if other than guideline:
- Regulation 440/2008, Method 1140: “Skin Corrosion”, May 30, 2008 (1).
OECD (2002). OECD Guideline for the Testing of Chemicals. No. 431: In Vitro Skin Corrosion: Human Skin Model Test. 13 April 2004 (2).
(1) Council Regulation (EC) No. 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Communities L142, 394-399.
(2) OECD (2002). OECD Guideline for the Testing of Chemicals. No. 431: In Vitro Skin Corrosion: Human Skin Model Test. 13 April 2004. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- sodium hydrogen (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)phosphonate
- EC Number:
- 700-812-1
- Cas Number:
- 1189052-95-6
- Molecular formula:
- C8H5F13O3PNa
- IUPAC Name:
- sodium hydrogen (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)phosphonate
- Details on test material:
- - Name: FHP-OHS
- Batch No.: Z1601
Component 1:
- Chemical Name: 3,3,4,4,5,5,6,6,7,7,8,8,8-Tridecafluorooctyl-
phosphonic acid sodium salt (1:1)
- CAS No.: 1189052-95-6
- Formula: C8H5F13O3P*Na
- Purity: 93%
Component 2:
- Chemical Name: 3,3,4,4,5,5,6,6,7,7,8,8,8-Tridecafluorooctyl-
phosphonic acid
- CAS No.: 252237-40-4
- Formula: C8H6F13O3P
- Purity: 7%
- Date of Manufacture: 9 June 2011
- Expiration Date: 3 years
- Colour: white to yellow
- Storage Conditions: at room temperature
- Date of Analysis: 10 June 2011
- Safety Precautions: Routine hygienic procedures were
- sufficient to assure personnel health and
safety
Constituent 1
Test animals
- Species:
- other: EpiDermTM Skin Model was used
- Strain:
- other: in vitor study so N/A
- Details on test animals or test system and environmental conditions:
- N/A
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: invitro so no requirement
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- Dose Groups:
1. Negative control 50 µL distilled water
2. Positive control 50 µL 8 N KOH
3. Test Item 25mg + 25 µL H20
The test was performed on a total of 4 tissues per dose group, 2 replicates for each treatment period (3 min. and 60 min. exposure time). - Duration of treatment / exposure:
- The test was performed on a total of 4 tissues per dose group, 2 replicates for each treatment period (3 min. and 60 min. exposure time)
- Observation period:
- 60 mins
- Number of animals:
- N/A
- Details on study design:
- Test System: The test was carried out with the reconstituted three-dimensional human skin model EpiDermTM (MatTek). This skin model consists of normal (non-cancerous), human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell®). The EpiDermTM skin model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous, granular and cornified layers analogous to those found in vivo.
Pre-Experiment: To check the MTT-reducing capability of the test item 30 mg of the test item were mixed with 1 mL MTT medium and incubated for 1 h at room temperature. If the mixture turns blue/purple, the test item is presumed to have reduced MTT. This check can only be used to explain unexpected results, but it can not be used for quantitative correction of results.
Experimental Procedure: Upon receipt of the EpiDermTM - kit, the tissues were transferred into 6-well plates containing 900 µL prewarmed assay medium per well. The 6-well plates were pre-incubated in a humidified incubator at 37 ± 1°C, 5.0% CO2 / 95% air for at least 1 h. Then the medium was replaced by 900 RL fresh assay medium. The 6-well plate used for the 3 mm. experiment was placed back into the incubator. The other plate was used for the 60 mi treatment. About 1 h before the end of the first treatment period the MTT solution was prepared by mixing the MTT concentrate with the MTT diluent and pre-warmed in the incubator.
60 min. experiment: the tissues were treated with each dose group in duplicate, starting with the negative control. Start time was recorded with dosing of the first tissue. Then the 6-well plate was incubated at 37 ± 1°C, 5.0% CO2 / 95% air.
3 min. experiment: the tissues were treated with each dose group in duplicate, starting with the negative control. Start time was recorded with dosing of the first tissue. A constant time interval of 20 sec. was kept between dosing. After 3 mm. of application, with foreceps, the first insert was removed from the 6-well plate. Using a wash bottle the tissue was gently rinsed about 20 times with PBS (phospate buffered saline) to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper. The insert was placed in a prepared 24-well “holding plate” containing 300 RL prewarmed assay medium per well. All inserts were treated in the same manner. Then the inserts were transferred into a prepared 24-well “MTT assay plate” containing 300 µL prewarmed MTT solution, The plate was incubated for 3 h at 37 ± 1 °C, 5.0% CO2 / 95% air.
60 min. experiment: after 60 min. application, with foreceps, the first insert was removed from the 6-well plate. Using a wash bottle the tissue was gently rinsed about 20 times with PBS to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper. The insert was placed in a prepared 24-well “holding plate” containing 300 µL prewarmed assay medium per well. All inserts were treated in the same manner. Then the inserts were transferred into a prepared 24-well “MTT assay plate” containing 300 µL prewarmed MTT solution. The plate was incubated for 3 h at 37 ± 1°C, 5.0% CO2 / 95% air.
3 min. and 60 min. experiment: after the 3 h MTT incubation period the MTT solution was aspirated. The wells were refilled with PBS and the PBS was aspirated. The rinsing was repeated twice and the tissues were dried. Then the inserts were transferred into new 24-well “extraction plates”. 2 mL of isopropanol were pipetted into each insert, thus the insert was covered from both sides. The extraction plates were sealed in zip-bags to inhibit isopropanol evaporation. Extraction was carried out over night without shaking at room temperature.
After the extraction period the inserts were pierced with an injection needle to allow the extracts to run through the tissues into the corresponding wells. Then the inserts were discarded and the extraction plates were placed on a shaker for 15 min.
Per each tissue 3 x 200 µL aliquots of the extract were transferred into a 96-well plate and OD was measured at 550 nm without reference wavelength in a plate spectrophotometer.
Results and discussion
In vivo
- Irritant / corrosive response data:
- See Attahced repot
- Other effects:
- none
Any other information on results incl. tables
Pre-Experiment:The mixture of 100 µL / 30mg test item per 1 ml MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. For table see attached report * mean OD550≥ 0.8 ** mean relative tissue viability of the 3 min. positive control ≤30% *** inter tissue viability difference ≤ 30% for table see attaced report * mean OD550≥ 0.8 *** inter tissue viability difference ≤ 30%
Historical data:
For table see attached report
The potential of the test item to induce skin corrosion was analysed by using the three-dimensional human skin model EpiDermTM, comprising a reconstructed epidermis with a functional stratum corneum.
In the present study FHP-OHS was applied topically to the EpiDermTMtissue for 3 min. and 60 min. followed by immediate determination of cytotoxic effects via MTT reduction assay.
Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods compared to the corresponding negative control tissues concurrently treated with A. dest.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥ 50% (88%) after 3 mm. treatment and ≥ 15% (83%) after 60 min. treatment.
The controls confirmed the validity of the study. The mean 0D550of the two negative control tissues was ≥ 0.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was ≤ 30% (12%) after 3 min. treatment. The maximum inter tissue difference of replicate tissues of all dose groups was ≤ 30% (1.3% - 14.8%). |
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non corrosive”.
- Executive summary:
In the present study the skin corrosivity potential of FHP-OHS was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDermTM, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min. and 60 min. exposure period and compared to those of the concurrent negative controls.
In this study under the given conditions the test item showed no corrosive effects. The relative mean tissue viability after 3 min. treatment was ≥ 50% and after 60 min. treatment ≥ 15%. The test item is therefore classified as “non corrosive”.
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.