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EC number: 223-810-8 | CAS number: 4083-64-1
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From October 2012 to December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is performed in accordance with GLP and OECD guideline 402.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Toluene-4-sulphonamide
- EC Number:
- 200-741-1
- EC Name:
- Toluene-4-sulphonamide
- Cas Number:
- 70-55-3
- Molecular formula:
- C7H9NO2S
- IUPAC Name:
- 4-methylbenzenesulfonamide
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): p-Toluenesulphonamide (PTSA)
- Substance type: White crystalline
- Physical state: Solid
- Lot/batch No.: Confidential
- Expiration date of the lot/batch: Confidential
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study:
- Housing: animals were housed in suspended solid floor polypropene cages furnished with woodflakes. Animals were housed individually during the 24-hour exposure period and in groups of 4, by sex, for the remainder of the study
- Diet (e.g. ad libitum): ad libitum (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From: 07 November 2012 To: 28 November 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Distilled water and dimethyl sulphoxide (DMSO)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed by wiping the treated skin and surrounding hair with cotton wool moistened with distilled water and dimethyl sulphoxide (DMSO)
- Time after start of exposure: 24 hours after application of test substance
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
- Concentration (if solution): no information available
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): no information available
- Concentration (if solution): no information available
- Lot/batch no. (if required): no information available
- Purity: no information available - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual bodyweights prior to dosing and 7 and 14 days after treatment. Mortality and clinical observations at 0.5, 1, 2, and 4 hours after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not relevant
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 0/10 deaths
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No signs of systemic toxicity were observed
- Gross pathology:
- One male showed thickened non-glandular epithelium of the stomach at necropsy. No abnormalities were noted at necropsy of the other animals.
- Other findings:
- There were no signs of dermal irritation
Any other information on results incl. tables
Not relevant
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, the acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater then 2000 mg/kg bw. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with according to the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).
- Executive summary:
An acute dermal toxicity test (limit test) was performed with p-Toluenesulphonamide as testing material. The test was performed according to OECD guideline 402 (Acute dermal toxicity) in a group of 10 rats (5 males, 5 females). The rats were dermally exposed to the substance at 2000 mg/kg bw for 24 hours. The substance was applied to a shorn skin (approximately 10% of body surface). A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
No mortality was observed in the 14 days period after exposure. No signs of systemic toxicity were observed during clinical observation. No signs of dermal irritation were noted in the animals. One male showed thickened non-glandular epithelium of the stomach at necropsy. No abnormalities were noted at necropsy of the other animals. Overall body weight of all animals increased during study.
The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat, was found to be >2000 mg/kg bw. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).
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