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EC number: 614-396-3 | CAS number: 68298-12-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- No deviations ocurred that impacted the integrity of the study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N-methylbutane-1-sulfonamide
- EC Number:
- 614-396-3
- Cas Number:
- 68298-12-4
- Molecular formula:
- C5H4F9NO2S
- IUPAC Name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N-methylbutane-1-sulfonamide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
3M Company, Lot 3
- Expiration date of the lot/batch:
06 August, 2002
- Purity test date:
30 January, 2002
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature in the dark.
- Stability under storage conditions:
Stable
- Stability under test conditions:
Stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
The test article was tested neat.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The test article was uniformly ground into a powder using a mortar and pestle prior to weighing and dosing.
- Final preparation of a solid:
Dosed as a powder.
FORM AS APPLIED IN THE TEST: The test article was dosed as a powder.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: 7-9 weeks old
- Weight at study initiation: 1.58-1.62 kg
- Housing: Individually in labelled cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day.
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 06 November, 2001, To: 09 November, 2001
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with deionized water.
VEHICLE : Deionized water
- Amount(s) applied (volume or weight with unit): Enough to slightly moisten the solid.
NEGATIVE CONTROL : None
POSITIVE CONTROL : None - Duration of treatment / exposure:
- The test article was kept in contact with the skin for 4 hours with a semi-occlusive patch.
- Observation period:
- Observations were made at 1, 24, 48, and 72 hours.
- Number of animals:
- 3 males.
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal (10 x 15 cm)
- % coverage: Approximately 10%.
- Type of wrap if used: A 2 x 3 cm metalline patch mounted with micropore tape and secured around the abdomen with a coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was washed with water to clear residual test article.
- Time after start of exposure: 4 hours.
OBSERVATION TIME POINTS
1, 24, 48, and 72 hours
SCORING SYSTEM:
- Method of calculation:
Erythema and eschar formation:
0 - No erythema
1 - Very slight erythema
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness)
Edema Formation
0 - No edema
1 - Very slight edema
2 - Slight edema
3 - Moderate edema (raised approximately 1 mm)
4 - Severe edema (raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no abnormal clinical signs or changes in body weight. No erythema was observed in any animal throughout the study. Edema (scores: 1) was observed in 2/3 animals at 1 hour postdose and resolved by 24 hours postdose. The PII was 0.0/8.0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study (PII = 0.0/8.0), the test article is not a dermal irritant.
- Executive summary:
The primary skin irritation potential of T-7601 (off white solid, Lot 3) was evaluated in New Zealand White rabbits. This study was performed in accordance with OECD GLP. The study design was based on OECD 404 (1992) and Commission Directive 92/69/EEC B.4 (1992). The hair was clipped from the dorsal skin of three male rabbits. The test material (0.5 g) was moistened with deionized water and placed under a metalline patch on the back of each animal and secured with micropore tape. The torso was wrapped with a coban bandage in a semi-occlusive manner for a 4-hour exposure. Observations for skin irritation (erythema and edema) were recorded at 1, 24, 48 and 72 hours after unwrapping. The Primary Irritation Index (PII) was calculated. There were no abnormal clinical signs or changes in body weight. No erythema was observed in any animal throughout the study. Edema (scores: 1) was observed in 2/3 animals at 1-hour post dose and resolved by 24 hours post dose. The PII was 0.0/8.0. Based on the results of the study (PII = 0.0/8.0), the test article is not a dermal irritant.
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