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EC number: 252-044-7 | CAS number: 34455-00-0
- 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
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- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines including the most recent partial revisions
- Version / remarks:
- 2011
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-bis(2-hydroxyethyl)butane-1-sulphonamide
- EC Number:
- 252-044-7
- EC Name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-bis(2-hydroxyethyl)butane-1-sulphonamide
- Cas Number:
- 34455-00-0
- Molecular formula:
- C8H10F9NO4S
- IUPAC Name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-bis(2-hydroxyethyl)butane-1-sulfonamide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: F-12676, PDC lot 20
- Expiration date of the lot/batch: 03 September 2013 (allocated by WIL Research Europe B.V., 1 year after receipt of the test substance)
- Purity test date: 99.96%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The powdery test substance was moistened with water (Elix, Millipore S.A.S., Molsheim, France), immediately before application, to ensure close contact with the animal's skin. No corrections were made for the purity/composition of the test substance, since the guidelines requires a fixed amounts that has to be dosed.
FORM AS APPLIED IN THE TEST (if different from that of starting material): The powdery test substance was moistened with water (Elix, Millipore S.A.S., Molsheim, France) immediately before application
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: 1638.3 g (average)
- Housing: Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm)
- Diet (e.g. ad libitum): Diet Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40-70%
- Air changes (per hr): Approximately 15 room air changes/hour
- Photoperiod (hrs dark / hrs light): 12:12 light:dark cycle
IN-LIFE DATES: From: 13 November 2012 To: 22 November 2012
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened with 0.5 mL water) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2 x 3 cm using a metalline patch
- Type of wrap if used: The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin cleaned of residual test substance using tap water
- Time after start of exposure: 4 hours post application
OBSERVATION TIME POINTS
Skin reactions were assessed at approximately 1, 24, 48, and 72 hours after removal of the dressings and test substance
SCORING SYSTEM:
Erythema and eschar formation:
No erythema .......................................................................................................................... 0
Very slight erythema (barely perceptible) ............................................................................... 1
Well-defined erythema ........................................................................................................... 2
Moderate to severe erythema ................................................................................................. 3
Severe erythema (beet redness) * .......................................................................................... 4
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.
Oedema formation:
No oedema ............................................................................................................................ 0
Very slight oedema (barely perceptible) ................................................................................. 1
Slight oedema (edges of area well-defined by definite raising) ............................................... 2
Moderate oedema (raised approximately 1 millimeter) ........................................................... 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin irritation (erythema or edema) was caused by 4 hours exposure to the test article.
- Other effects:
- No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study (all scores 0, PII=0.0/8.0), the test article is not a skin irritant.
- Executive summary:
The skin irritation potential of the test article was evaluated in albino rabbits. The test was conducted under OECD GLP (1997) conditions. The test method was based on OECD No. 404 (2002), EC No. 440 (2008), US EPA, OPPTS 870.2500 (1998), and JMAFF Guidelines (2011). Three male rabbits were exposed to 0.5 grams of the test article moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Sites were cleaned of residual test substance using tap water after 4 hours of exposure. Animals were observed twice daily for mortality/viability, at least once daily for toxicity, and body weight was taken on the day of treatment (prior to application) and after the final observation. The exposed sites were examined at 1, 24, 48, and 72 hours and scored for erythema and edema. Erythema and edema scores of zero were reported at all time points for all animals (PII=0.0/8.0). Based on the results of the study (all scores 0, PII=0.0/8.0), the test article is not a skin irritant.
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