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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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity (males and female rats): LD50 = 2330 mg/kg bw
Acute dermal toxicity (male and female rats): LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A 2 page study report is available. The study was performed pre-GLP. The study was performed according to a method similar to OECD401. No data on substance identity or composition.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Very high dose volume. Animals were only observed for signs of intoxication and necropsy was performed on surviving animals.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Doses:
- 8.3, 10.0, 12.0, 14.4, 17.3 ml/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 330 mg/kg bw
- 95% CL:
- 2 080 - 2 600
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- From the mortality-figures the LD50 of para-toluene sulphonamide was calculated to be 2.33 g per kg body weight, with 2.08 and 2.60 as the 95% confidence limits. Therefore, the test substance does not need to be classified for Acute Oral Toxicity in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
- Executive summary:
An acute oral toxicity study was performed according to a method similar to OECD401 and pre-GLP. 5 male and 5 female rats were dosed with 8.3, 10.0, 1.20, 14.4 or 17.3 ml/kg bw. The animals were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors. Within a few hours after dosing the rats showed sluggishness, followed by loss of consciousness. Death occurred between 4 and 50 hours after dosing. Later on the survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors at autopsy revealed dark discolouration of the liver in the rats of all dose groups. Some of the rats showed mottled kidneys. No other signs of treatment-related gross alterations were seen. From the mortality-figures the LD50 of para-toluene sulphonamide was calculated to be 2.33 g per kg body weight, with 2.08 and 2.60 as the 95% confidence limits. Therefore, the test substance does not need to be classified for Acute Oral Toxicity in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
Reference
Results:
Within a few hours after dosing the rats showed sluggishness, followed by loss of consciousness. Death occurred between 4 and 50 hours after dosing. Later on the survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors at autopsy revealed dark discolouration of the liver in the rats of all dose groups. Some of the rats showed mottled kidneys. No other signs of treatment-related gross alterations were seen.
Dose |
Mortality |
|||
Suspension ml/kg |
Test substance g/kg |
males |
females |
% |
8.3 |
2.08 |
1/5 |
3/5 |
40 |
10.0 |
2.50 |
1/5 |
4/5 |
50 |
12.0 |
3.00 |
4/5 |
5/5 |
90 |
14.4 |
3.60 |
3/5 |
5/5 |
80 |
17.3 |
4.33 |
5/5 |
5/5 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 330 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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
- 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 - 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
- Preliminary study:
- Not applicable
- 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
- 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).
Reference
Not relevant
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
The results of PTSA are read across to PTSI. This is considered justified because PTSI is extremely reactive with water and reacts instantaneously into the source substance PTSA.This will occur on the skin and also inside the body. Thus, in practice, exposure will be to PTSA and not PTSI. Due to this extreme reactivity it is considered ethically not appropriate to perform the acute toxicity studies with PTSI.
An acute oral toxicity study with PTSA was performed according to a method similar to OECD401 and pre-GLP. 5 male and 5 female rats were dosed with 8.3, 10.0, 1.20, 14.4 or 17.3 ml/kg bw. The animals were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors. Sluggishness and loss of conscience were observed. Mortality was observed between 4 and 50 hours after dosing. The LD50 of PTSA was calculated to be 2.33 g per kg body weight, with 2.08 and 2.60 as the 95% confidence limits.
An acute dermal toxicity test (limit test) was performed with PTSA as testing material. The test was performed according to OECD guideline 402 (Acute dermal toxicity). 5 male and 5 female rats were dermally exposed to the substance at 2000 mg/kg bw for 24 hours. 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. Overall body weight of all animals increased during study. In conclusion, the acute dermal median lethal dose (LD50) was found to be >2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
One pre-GLP study available which was performed similar to the OECD guideline 401.
Justification for selection of acute toxicity – dermal endpoint
Reliable GLP study according to OECD Guideline 402
Justification for classification or non-classification
The test material does not meet the criteria for classification and will not require labelling for acute toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).
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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