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EC number: 940-803-1 | 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2020 - 25 March 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate
- EC Number:
- 940-803-1
- Molecular formula:
- This is a multi-constituent susbstance there is no molecular formula or molecular weight range available
- IUPAC Name:
- Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch number W19011506 JAN 18, 2019
Expiry date 15 January 2021
Purity ~30% active in water
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Healthy nulliparous and non-pregnant female RccHan™:WIST albino rats were obtained from Envigo RMS (UK) Ltd.
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals were housed inside a limited access rodent facility (Building F21, Room 044/045).
The facility was designed and operated to minimize the entry of external biological and
chemical agents and to minimize the transference of such agents between rooms.
The animal room was kept at positive pressure with respect to the outside by its own supply
of filtered fresh air, which was passed to atmosphere and not re-circulated. The temperature
and relative humidity controls were set to maintain the range of 20 to 24C and 40 to 70%
respectively. Any minor deviations from these ranges would not have had an adverse effect
on the animals and would not affect the integrity or validity of the study. Artificial lighting
was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per
24 hours. Environmental parameters are archived with the departmental raw data.
Periodic checks were made on the number of air changes in the animal rooms. Temperature
and humidity were monitored daily.
Alarms were activated if there was any failure of the ventilation system, or temperature limits
were exceeded. A stand-by electricity supply was available to be automatically brought into
operation should the public supply fail.
The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Each
cage contained a quantity of autoclaved softwood bark-free fiber bedding. Cages, food
hoppers, water bottles and bedding were changed at appropriate intervals.
The animals were allowed free access to a standard rodent diet (Teklad 2014C Diet). This
diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
Potable water taken from the public supply was freely available via polycarbonate bottles
fitted with sipper tubes.
Each cage of animals was provided with Aspen chew blocks or balls for environmental
enrichment. Chew blocks or balls were provided throughout the study and were replaced
when necessary. Each cage of animals was provided with a plastic shelter for environmental
enrichment, which was replaced at the same time as the cages.
Each batch of diet was analyzed routinely by the supplier for various nutritional components
and chemical and microbiological contaminants. Supplier’s analytical certificates were
scrutinized and approved before any batch of diet was released for use. The quality of the
water supply is governed by regulations published by the Department for Environment, Food
and Rural Affairs. Certificates of analysis were received routinely from the water supplier.
Certificates of analysis were received routinely from the supplier of the chew blocks or balls.
Since the results of these various analyses did not provide evidence of contamination that
might have prejudiced the study, they are not presented.
No other specific contaminants that were likely to have been present in the diet or water were
analyzed, as none that may have interfered with or prejudiced the outcome of the study was
known.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- One day prior to treatment, hair was removed from the dorso-lumbar region of each rat with
electric clippers taking care to avoid damaging the skin, exposing an area equivalent to
approximately 10% of the total body surface area.
The test item was applied by spreading it evenly over the prepared skin. The treatment area
was covered with porous gauze held in place with semi-occluded surgical tape encircled
firmly around the trunk of the animal.
Treatment in this manner was performed on Day 1 (day of dosing) of the study only.
At the end of the 24 hours exposure period the dressing was carefully removed and the
treated area of skin was washed with warm water (30 to 40°C), to remove any residual test
item.
A record of the weight of the formulation dispensed and the amount remaining after dosing
was made. The balance of these two weights was compared with the predicted usage as a
check that the doses had been administered correctly.
Formulations were stirred before and throughout the dosing procedure. - Duration of exposure:
- 24h
- No. of animals per sex per dose:
- 1 or 2
- Control animals:
- not required
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths and no systemic response to treatment in any animal.
- Other findings:
- Bandage reactions were seen in animals 71 and 72 from Day 2, these reactions had resolved
by Day 7 and 4, respectively. No other dermal irritation was seen in any animals.
Applicant's summary and conclusion
- Conclusions:
- The acute median lethal dermal dose (LD50) to rats of Thetawet FS-8250 was demonstrated to
be greater than 2000 mg/kg body weight.
Thetawet FS-8250 is included in Category 5/Unclassified, according to the Globally
Harmonised System (GHS).
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.
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