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EC number: 206-596-0 | CAS number: 355-93-1
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 October 2007 to 14 January 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- Only 8% of the body surface was covered
- GLP compliance:
- no
- Remarks:
- The study was not commissioned with compliance with REACH as a goal, rather the study was commissioned during early product development.
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2,3,3,4,4,5,5-octafluoropentyl methacrylate
- EC Number:
- 206-596-0
- EC Name:
- 2,2,3,3,4,4,5,5-octafluoropentyl methacrylate
- Cas Number:
- 355-93-1
- Molecular formula:
- C9H8F8O2
- IUPAC Name:
- 2,2,3,3,4,4,5,5-octafluoropentyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Q14A-14
- Purity: 99%
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Details on species / strain selection:
- The Sprague-Dawley rat was used because it is a widely used strain for which significant historical control data are available.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina
- Females nulliparous and non-pregnant: yes
- Age at study initiation: The animals were approximately 58 days old at the initiation of dose administration.
- Weight at study initiation: individual body weights ranged from 260 g to 298 g for males and from 190 g to 220 g for females.
- Housing: housed individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68.2°F to 70.6°F (20.1°C to 21.4°C)
- Humidity (%): 33.6% to 52.2%
- Air changes (per hr): minimum of 10 fresh air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 10 October 2007 To: 9 November 2007
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The test was conducted as non-GLP study. The test substance at the level of 0.91 mL/kg bw (equivalent to 1,300 mg/kg bw based on the density of 1.432 g/mL) was dosed to individual animals via dermal application to clipped dorsum under occlusive conditions once daily for a minimum of 6 hours per day for 28 consecutive days.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples were typically within 4% of expected concentration. Examination of the HPLC chromatograms showed OFPMA eluting near 1.55 minutes as expected, and revealed no incipient peaks.
- Duration of treatment / exposure:
- A minimum of 6 hours per day for 28 consecutive days.
- Frequency of treatment:
- 28 consecutive days
Doses / concentrations
- Dose / conc.:
- 1 300 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- All animals were observed twice daily for mortality and moribundity. Clinical examinations were performed daily. Detailed clinical examinations were performed weekly.
- Sacrifice and pathology:
- Pathology evaluations were performed on all animals on the day of scheduled necropsy (Day 28 of the study). Complete necropsies were conducted on all animals.
- Other examinations:
- Application sites were examined once per week at the time of the detailed physical examination and treated and untreated skin was examined macroscopically and microscopically. Individual body weights and food consumption were recorded weekly. Ophthalmic examinations were performed during study weeks -2 and 3. Blood and urine samples for clinical pathology evaluations (hematology, coagulation, serum chemistry and urinalysis) were collected from all animals on the day of the scheduled necropsy (study day 28).
- Statistics:
- All statistical tests were performed using appropriate computing devices or programs.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test substance-related effects noted on clinical findings, including dermal observations.
- Dermal irritation:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test substance-related effects noted on clinical findings, including dermal observations.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One male in test group was found dead on Day 13 of the study. The cause of the death was undetermined. Due to lack of significant indication of toxicity in the treated animals, this death was considered by the study authors to be likely not test substance related
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test substance-related effects noted on body weights.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test substance-related effects noted in haematology or coagulation parameters.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower total protein (-5%) and globulin (-9%) levels were recorded as treatment related alterations in serum chemistry parameters in the test substance treated males. The values for the total protein and globulin were within historical control ranges for the laboratory and hence study authors considered the alterations as non-adverse.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- There were no test substance-related effects noted in urinalysis parameters.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One statistically significant difference was observed when the vehicle control and test article-treated groups were compared. Mean thymus relative to final body weight was lower (13.4%) than the vehicle control group in the treated group males but was within the WIL historical control range (version 2.4) for male rats 9-12 and 13-15 weeks of age. This alteration was a function of a slightly lower (but also within the historical control ranges) mean absolute thymus weight and slightly higher mean final body weight in the treated group males and not an effect of test article administration.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- White area(s) were seen in the liver from 1 of 10 males and females in the treated group compared to none in the vehicle control group. These foci correlated to areas of hepatocellular necrosis seen histologically. However, smaller foci of necrosis, that went undetected at necropsy, were seen microscopically in vehicle control group rats, indicating that the white areas and hepatocellular necrosis were incidental changes unrelated to test article administration.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test substance related effects noted in selected organs and microscopic tissue samples. Minimal to mild acute inflammation of the urinary bladder was observed in 2 of 10 test substance treated females and was considered by the study authors to be related to the administration of the test substance and to be non-adverse. No test substance related microscopic findings were noted on treated skin tissues.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects noted at the dose level of 1300 mg/kg bw/day via dermal route
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Repeated dermal application of test substance to rats for 6 hours daily for 28 consecutive days was well-tolerated with no physical observations of toxicity. Evidence of systemic, non-adverse effects attributable to the test article was limited to lower total protein and lower globulin in treated males on study day 28. Although, the microscopic finding of minimal or mild acute inflammation of the urinary bladder observed in 2 treated females is considered to be related to test article administration, it does not appear to be adverse.
- Executive summary:
The test article was administered via dermal application to clipped dorsum (approximately 8% of total body surface area) once daily for a minimum of 6 hours per day for 28 consecutive days to 1 group (Group 2) of rats. The application site for each animal was covered with 8-ply gauze, covered with an occluded non-porous latex bandage and held in place with non-irritating tape. Elizabethan collars were applied to restrict access to the wrapped dosing site. The dosage level was 1300 mg/kg/day. A concurrent vehicle control group (Group 1) received the vehicle on a comparable regimen. The dose volume was 1.3 mL/kg for Group 1 and 0.91 mL/kg for Group 2. Each group consisted of 10 animals/sex. Following 28 days of dose administration, all animals were euthanized and necropsied.
All animals were observed twice daily for mortality and moribundity. Clinical examinations were performed daily, and detailed physical examinations were performed weekly. Application sites were examined once per week at the time of the detailed physical examination and treated and untreated skin was examined macroscopically and microscopically. Individual body weights and food consumption were recorded weekly. Ophthalmic examinations were performed during study weeks -2 and 3. Clinical pathology evaluations (hematology, coagulation, serum chemistry and urinalysis) were performed on all animals on the day of the scheduled necropsy (study day 28). Complete necropsies were conducted on all animals, and selected organs were weighed at the scheduled necropsy. Selected tissues were examined microscopically from all animals.
In the test article-treated group, one male was found dead on study day 13. While the cause of death was undetermined, due to overall lack of significant indications of toxicity in the treated animals, this death was probably not test article-related. There were no test article-related effects on clinical findings, including dermal observations, nor any test article-related effects on body weights, food consumption, hematology, coagulation or urinalysis parameters or organ weights were noted. There were no test article-related macroscopic findings. There were no test article-related microscopic findings on treated skin.
Test article-related non-adverse alterations in serum chemistry parameters included lower total protein and glucose levels in the treated males when compared to the vehicle control group. A test article-related but non-adverse microscopic finding was minimal or mild acute inflammation of the urinary bladder observed in 2 treated females.
Repeated dermal application of test substance to rats for 6 hours daily for 28 consecutive days was well-tolerated with no physical observations of toxicity. Evidence of systemic, non-adverse effects attributable to the test article was limited to lower total protein and lower globulin in the treated males on study day 28. Although, the microscopic finding of minimal or mild acute inflammation of the urinary bladder observed in 2 treated females is considered to be related to test article administration, it does not appear to be adverse.
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