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EC number: 252-043-1 | CAS number: 34454-97-2
- 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:
- 30 October 2001 to 02 November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- T-7599
- IUPAC Name:
- T-7599
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):T-5499
- Physical state: White powder
- Analytical purity: >99.9 percent 1-Butanesulfonamine, 1, 1, 2, 2, 3, 3, 4, 4, 4,-Nonafluoro-n-(2-Hydroxyethyl)-N-Methyl- and <0.1 percent Methylamine
- Lot/batch no.: Lot 6
- Expiration date of the lot/batch: 7 August 2002
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature in the dark
Constituent 1
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
- Sex: male
- Weight at study initiation: 1435-1571 grams
- Fasting period before study: none
- Housing:- Diet (e.g. ad libitum): Standard laboratory rabbit diet approx. 100 g. per day.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/- 3 degrees C
- Humidity (%): 30-70 percent
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour artificial fluorescent light/12 hours dark
IN-LIFE DATES: From: 30 October 2001 To: 02 November 2001
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test substance moistened with 0.5 ml water
VEHICLE
- Amount(s) applied (volume or weight with unit): moistened with 0.5 ml water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after exposure period.
- Number of animals:
- 3 males.
- Details on study design:
- TEST SITE
- Area of exposure: 150 square centimeters
- Type of wrap if used: Coban elastic bandage
- A 2x3 cm metalline patch mounted on Micropore tape (secured with a coban bandage) were used to apply the test substance to the skin of the animal
- The test substance was moistened with Milli-U water immediately before application to ensure close contact with animal's skin
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed clean with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Erythema and eschar formation numerical scoring and edema numerical scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All animals have scores of zero at all measured time points during the study.
Any other information on results incl. tables
No evidence of a corrosive effects, coloration, systemic toxicity or mortality were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article does not have to be classified and has no obligatory labeling requirements for skin irritation based on EC criteria.
- Executive summary:
A primary skin irritation/corrosion study was performed with the test article according to OECD Study Guideline no. 404 (2002). Three New Zealand White albino male rabbits were exposed to 0.5 grams (slightly moistened) of the test article by application onto clipped skin using a semi-occlusive dressing. The exposure period lasted for 4 hours, and then skin reactions were assessed at 1, 24,48 and 72 hours after exposure. Irritation scores of zero were given to all animals (no erythema or oedema were formed). No evidence of a corrosive effects, coloration, systemic toxicity or mortality were observed at any time during the observation period. Therefore, the test article does not have to be classified and has no obligatory labeling requirements for skin irritation based on the EC criteria.
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