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Diss Factsheets
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EC number: 206-792-6 | CAS number: 375-72-4
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 January and 23 February
- 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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Remarks:
- The bodyweight of a number of animals used was above the upper protocol weight range of 500 g at the start of the study, however, this was not considered to have affected the validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- not specified
- Remarks:
- The bodyweight of a number of animals used was above the upper protocol weight range of 500 g at the start of the study, however, this was not considered to have affected the validity or integrity of the study.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- T-7499
- IUPAC Name:
- T-7499
- Details on test material:
- - Name of test material (as cited in study report: T-7499; Perfluorobutanesulfonyl fluoride
- Physical state: liquid/gas
- Analytical purity: 98%
- Lot/batch no.: not advised
- Expiration date of the lot/batch: April 26 2001
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkin-Hartley , Albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:D.Hall, Newchurch,Staffs, UK.
- Age at study initiation: four to seven weeks of age on arrival
- Weight at study initiation: 441 - 580 g
- Housing: housed in groups of five in suspended metal cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum to a vitamin C enriched guinea-pig diet.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 degrees C.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal injection and topical application.
- Vehicle:
- other: Alembiocol D ( a coconut oil product, supplied by Alemic Products, Salthney, Chester, England
- Concentration / amount:
- 10% v/v Alembicol D
Challengeopen allclose all
- Route:
- other: topical application
- Vehicle:
- other: Alembiocol D ( a coconut oil product, supplied by Alemic Products, Salthney, Chester, England
- Concentration / amount:
- 10% v/v Alembicol D
- Details on study design:
- RANGE FINDING TESTS:Intradermal injections (0.1ml/site) were made into the clipped and shaved flank of two guinea pigs, using a range of concentrations (0.1 to 10% v/v) of the test article in a suitable vehicle (Alemibicol D). The resulting dermal responses were assessed approximately 24 and 72 houus later. Topical application occured by saturated patches of Whatman No.3 paper with 25% v/v to as supplied of the test article in the vehicle and applied to the clipped and shaved flanks of each of four guinea pigs. Patches were semiocclusive and dressings were removed after 24 hours of exposure. The reaction sites were assessed for erythema and edema. Further examination of the sites was carried out approximatly 24 and 48 hours after removal of the dressing.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs (intradermal)
- Exposure period: 48 hours
- Test groups: test animals 10 animals
- Control group: 5 control animals
- Site: Intradermal injections in the dorsal skin fo the scapular region
- Concentrations: 1% v/v in Alembicol D
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after topical induction
- Exposure period: 24 hours
- Test groups: 10 animals
- Control group: 5 control animals
- Site: left flank of each guinea pig
- Concentrations: 50% v/v test substance in Alembicol D and as supplied. .
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- HCA produced evidence of skin sensitisation in all of the ten animals, confirming the sensitivity of the strain of animals and reliability of the expoerimental techinique
In vivo (non-LLNA)
Results
- Reading:
- other: The induction exposure caused slight irritation in test animals at sites receiveing the test article, 1% v/v in Alembicol D and slight irritaiton in control animals recieving Alembicol D after intradermal injection. After topical appliaction, slight eryth
- Group:
- other: all groups tested
- Dose level:
- 1% v/v in Alembicol D for intradermal injection, as supplied for the topical application and as supplied and at 50% v/v in Alembicol D.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- The above number of animals are those that had a positive response after the challenge application of the test article. 7 of the 10 test animals showed slight erythema after topical application in the indu
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: The induction exposure caused slight irritation in test animals at sites receiveing the test article, 1% v/v in Alembicol D and slight irritaiton in control animals recieving Alembicol D after intradermal injection. After topical appliaction, slight eryth. Group: other: all groups tested. Dose level: 1% v/v in Alembicol D for intradermal injection, as supplied for the topical application and as supplied and at 50% v/v in Alembicol D. . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: The above number of animals are those that had a positive response after the challenge application of the test article. 7 of the 10 test animals showed slight erythema after topical application in the indu.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test article did not produce evidence of skin sensitization in any of the ten test animals. The test article is not considered to have to potential to cause skin sensitization. As all of the animals have negative responses, the test article does not require labelling with the risk phrase R43 "May cause sensitization by skin contact" in accordance with Commission Directive 93/21/EEC
- Executive summary:
This study was performed to assess the skin sensitization potential of the test article using the guinea-pig (OECD 406, EPA OPPTS 870.2600, EEC Annex to Directive 96/54/EC, Part B, Method B.6.). The guinea pigs were dosed by intradermal injection and topical application, as these are the routes of exposure required by the test guidelines and method. Based on results of a preliminary study and in compliance with the guidelines, the following dose levels were selected: 1% v/v in Alembicol D for the intradermal injection route; as supplied for the topic application; as supplied and 50% v/v in Alembicol D. Ten test and five-control guinea-pigs were used in this study. In this study, the test article did not produce evidence of skin sensitization in any way of the ten test animals. The test article does not require labelling with the risk phrase R43 "May cause sensitization by skin contact" in accordance with Commission Directive 93/21/EEC.
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