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EC number: 232-465-2 | CAS number: 8047-99-2
- 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:
- 13 Aug 1985 - 16 Aug 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 12 May 1981)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-ethyl-o(or p)-toluenesulphonamide
- EC Number:
- 232-465-2
- EC Name:
- N-ethyl-o(or p)-toluenesulphonamide
- Cas Number:
- 8047-99-2
- Molecular formula:
- C9H13NO2S
- IUPAC Name:
- N-ethyl-4-methylbenzene-1-sulfonamide
- Test material form:
- liquid: viscous
- Remarks:
- Colour: light yellow
- Details on test material:
- Ketjenflex 8 (NETSA)
Chemical name in report: N-ethyl-o/p-toluenesulfonamide (or N-substituted toluene sulphonamide)
Description: light yellow viscous liquid
Purity 100% (or 90%)
Test substance storage: at room temperature in the dark
Stability under storage conditions: stable
Constituent 1
- Specific details on test material used for the study:
- - Chemical name: N-substituted toulene sulphonamide
- Trade name/code: Ketjenflex 8
- Impurity: Approx. 10% o/p toulene sulfonamide
- Specific gravity: Approx. 1200 kg/m3 (at 25 ̊ C)
- Solubility: Organic solvents except petroleum hydrocarbons
- Flash point: 224 ̊ C
- Boiling point: > 340 ̊ C
- Vapour pressure: < 1mm Hg at 150 ̊ C
- Appearance: Light yellow, viscous liquid
- Storage: At ambient temperature in the dark
- Stability: Practically unlimited
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF quality
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Obtained from The Broekman Institute, Someren,The Netherlands.
- Age at study initiation: Approximately 15 weeks old
- Weight at study initiation: 2750, 2701 and 2865 g
- Housing: In metal cages with perforated floors
- Diet (e.g. ad libitum): They were fed standard laboratory animal diet (100 g per day), obtained from Hope Farms, woerden (LK-01, pellet diameter 4mm)
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: Quarantine period was 7 days followed by an acclimation period of approximately 2.5 months
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): Relative humidity 50-70
- Photoperiod (hrs dark / hrs light): The artificial light sequence was 12 hours light, 12 hours dark.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): Undiluted
- Duration of treatment / exposure:
- Exposure duration was 4 hours
- Observation period:
- The exposed skin areas were examined for signs of erythema and oedema, and the responses were scored at 60 minutes, and approximately 24, 48 and 72 hours after removal of the dressing. For reference, the control site on the contralateral flank was used.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Test substance was applied to the right flank of each animal, the left flank being covered with the same dressing without test substance
- Coverage: approximately 10cm x 10 cm
- Type of wrap if used: gauze patch
- Administration: 0.5ml of the test substance was applied to a 6cm^2 gauze patch, which was attached with a drop of petrolatum to aluminum foil and mounted on permeable tape (Micropore, #M, St Paul, USA). This was then wrapped with flexible bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining test substance was removed using a tissue moistened with tap water after exposure duration of 4 hours.
OBSERVATION TIME POINTS
- 60 minutes, 24 hours, 28 hours and 72 hours after removal of the dressing
SCORING SYSTEM:
- Method of calculation: Skin irritation grading system based on OECDTG 404 (1981)
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
- Remarks on result:
- other: Mean value
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Mean value
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Mean value
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Mean value
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Mean value
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Mean value
- Irritant / corrosive response data:
- The skin of all three animals showed no reactions. The primary irritation index was 0 ( total of 24 and 72 hours scores for erythema and oedema, divided by 6).
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- according to the EU classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Conclusions:
- Under the conditions of this test the skin of all three animals showed no reactions. The primary irritation index was 0.
- Executive summary:
A skin irritation study was conducted according to OECD guideline 404, 1981, using the test material Ketjenflex 8 on the flank skin of 3 female New Zealand white strain rabbits. Each test site was treated with 0.5 ml of the undiluted test material for 4 hours using semiocclusive dressing. Observations for dermal irritation were made at 1, 24, 48 and 72 hours after removal of the patch. No significant test substance related effect was observed. The primary skin irritation index amounted to 0. Ketjenflex 8 can therefore be considered as non irritating to skin under the conditions of this study and does not have to be classified according to the EU classification criteria outlined in Annex I of 1272/2008/EC (CLP).
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