Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECDTG 404): not irritant
Eye irritation (OECDTG 405): not irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 12 May 1981)
- GLP compliance:
- yes
- 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 - 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. - 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) - 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).
- 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).
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 August 1985 - 22 August 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 12 May 1981
- GLP compliance:
- yes
- 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 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: 3378, 3165 and 3044 g
- Housing : In metal cages with perforated floors (RUCO, Valkenswaard).
- 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 - 22
- Humidity (%): Relative humidity 60-70
- Photoperiod (hrs dark / hrs light): The artificial light sequence was 12 hours light, 12 hours dark. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of the test substance
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Prior to dose administration, both eyes of the animals were inspected in order to detect any eye defect. Immediately after instillation of the test substance, the animals were observed and abnormalities were recorded. In addition, the eyes were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Grading of ocular lesions based on OECD 405 (1981)
TOOL USED TO ASSESS SCORE: fluorescein treatment
- a solution of 2% fluorescein in water (pH adjusted to 7.0) was applied to both eyes of each animal to examine quantitatively the potential for corneal injury - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- animal #1
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Remarks:
- Redness
- Basis:
- animal #2
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Mean Value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- One hour after instillation of the test substance swelling of the conjunctivae above normal was observed in all three animals. At the same time conjunctival redness was scored as grade 2 for two animals and grade 1 for the remaining animal. These signs were reversible since by the following day swelling had completely disappeared in all animals and redness was decreased to grade 1 in the remaining animal. 48 hours after instillations no more abnormal conjunctival redness or swelling was observed. No effects of the cornea and iris were observed in any of the animals. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage in any of the animals.
- 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, no effects of the cornea and iris were observed in any of the animals.
- Executive summary:
To investigate the potential eye irritating effects of Ketjenflex 8, a study was conducted according to OECD 405 (adopted in 1981). 0.1 ml of the test substance was applied by instillation into one eye of, in total three female New Zealand White rabbits. No effects of the cornea and iris were observed in any of the animals. One hour after instillation moderate redness and mild was temporarily observed, however effects were reversible after 24 to 48 hours. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage in any of the animals. Based on these results, it can be concluded that Ketjenflex 8 does not need to be classified as an eye irritant according to the EU classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion (OECD TG 405)
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.
Eye irritation (OECD TG 405)
To investigate the potential eye irritating effects of Ketjenflex 8, a study was conducted according to OECD 405 (adopted in 1981). 0.1 ml of the test substance was applied by instillation into one eye of, in total three female New Zealand White rabbits. No effects of the cornea and iris were observed in any of the animals. One hour after instillation moderate redness and mild was temporarily observed, however effects were reversible after 24 to 48 hours. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage in any of the animals. Based on these results, it can be concluded that Ketjenflex 8 does not need to be classified as an eye irritant.
Justification for classification or non-classification
Based on the available information, the substance N-Ethyl-o (or p)-toluenesulfonamide (NETSA) does not need to be classified for skin irritation and eye irritation, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.