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Diss Factsheets
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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 November 2001 to 27 December 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:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: EC Council Directive 67/548/EEC, Annex V, Part B
- Qualifier:
- according to guideline
- Guideline:
- other: "Allergic Contact Dermatitis in the Guinea-Pig: Identification of Contact Allergens" Magnusson B. Kligman A.M., 1970 published by C.C. Thomas, Springfield, Illinois USA
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was conducted prior to the requirement for the local lymph node assay.
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-5799
- Substance type: White powder
- Analytical purity: >99.9% 1-Butanesulfonamide, 1, 1, 2, 2, 3, 3, 4, 4, 4-Nonafluoro-n(2-Hydroxyethyl)-N-Methyl-; <0.1% Methylamine
- Lot/batch no.: Lot 6
- Expiration date of the lot/batch: 07 August 2002
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: Approx. 4 weeks old
- Weight at study initiation: 290-321g ( mean 312g in control group); 302-346 g (mean 320g in experiemental group)
- Housing: Group housing of 5 animals per labelled metal cage with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 fluorescent light/12 dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction exposures: 5%
Epidermal challenge: 20%
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction exposures: 5%
Epidermal challenge: 20%
- No. of animals per dose:
- 10 experimental animals, 5 control animals.
- Details on study design:
- RANGE FINDING TESTS:
100%, 50%, 20%, 10%, 5%, 2%, 1% test concentrations were administered via intradermal and epidermal application using 4 animals. This test procedure was identical to the procedure used in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:Two
- Exposure period: 48 hours
- Test groups: 2 animals
- Site: clipped scapular region
- Frequency of applications: Single
- Duration: 48 hours
- Concentrations: 20%, 10%, 5%, 2%
B. CHALLENGE EXPOSURE
- No. of exposures:2 per animal
- Day(s) of challenge: 2 days
- Exposure period: 48 hours
- Test groups: 4 animals
- Site: clipped scapular region
- Concentrations:2%, 5%, 10% and 20%
- Evaluation (hr after challenge): 48 hours - Challenge controls:
- alpha-hexylcinnamic aldehyde
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamic aldehyde
Results and discussion
- Positive control results:
- Female guinea pig of the albino Dunkin Hartley strain is an appropriate model for the performance of studies designed to evaluate the sensitising potential of a substance in a Maximisation test.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormal clinical signs were observed upon challenge.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormal clinical signs observed upon challenge.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There was no evidence that the test article had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of zero percent. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test article does not have to be classifed and has no obligatory labelling requirement for sensitisation by skin contact.
- Executive summary:
This study was carried out based on the guidelines in the EC Commission Directive 96/54/EC, Part B.6 and OECD number 406 and EPA OPPTS 870.2600. The test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 20% concentration of the test substance. Five control animals were similarly treated with the vehicle (polyethylene glycol) alone. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application, all animals were challenged with a 20% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence that the test article had caused skin hypersensitivity in the guinea pig, since no response were observed in the experimental animals in the challenge phase. This result indicates a sensitization rate of zero percent. Based on these results and according to the EC criteria for classification and labeling requirements for dangerous substances and preparations, the test article does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact.
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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