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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-550-0 | CAS number: 825-90-1
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Assessment based on available physicochemical properties and toxicological data
- Adequacy of study:
- weight of evidence
- Study period:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Assessment based on available physicochemical properties and toxicological data as per ECHA guidance R7.c
- Justification for type of information:
- None
- Objective of study:
- other: Assessment of basic toxicokinetic properties
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA Guidance R7.c
- Deviations:
- not applicable
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Radiolabelling:
- no
- Conclusions:
- Sodium 4-hydroxybenzenesulfonate would be absorbed primarily in gastrointestinal tract, while poor absorption via dermal and inhalation exposure is expected. Systemic distribution would most likely be restricted owing to the hydrophilic nature, while metabolism would be limited and it will be predominantly excreted via urine.
- Executive summary:
Sodium 4-hydroxybenzenesulfonate would be absorbed primarily in gastrointestinal tract, while poor absorption via dermal and inhalation exposure is expected. Systemic distribution would most likely be restricted owing to the hydrophilic nature, while metabolism would be limited and it will be predominantly excreted via urine.
Reference
Absorption
Oral/gastrointestinal absorption:
Based on the molecular weight of 196.2g/mol, Sodium 4-hydroxybenzenesulfonate, is expected to favour oral absorption. With the high water solubility of 92.4 g/L, Sodium 4-hydroxybenzenesulfonate may readily dissolve into the gastrointestinal fluids and be absorbed via passive diffusion.
Sodium 4-hydroxybenzenesulfonate and structurally similar sodium xylenesulfonate were found to be of low acute oral toxicity. toluene-4-sulfonic acid did not lead to test substance related adverse effects, as NOAEL was adjudged to be >500 mg/kg bw/day, the highest tested dose in the 28-day oral toxicity study. However, sodium xylenesulfonate was determined to have a NOAEL of 763 mg a.i./kg bw/day in a 90-day oral feeding study conducted in rats, as the LOAEL was determined to be 4092 mg a.i./kg bw/day (next and highest dose tested) on the basis of relative spleen weight loss in males seen at this dose level.
The findings from the repeated dose toxicity study with sodium xylenesulfonate were indicative of absorption taking place from the gastrointestinal tract, which can be considered to be the case with Sodium 4-hydroxybenzenesulfonate as well. Hence, on the basis of hydrophilic nature and the findings of the toxicological studies as discussed above, Sodium 4-hydroxybenzenesulfonate is expected to be absorbed by the gastrointestinal tract when administered orally.
Dermal absorption:
Sodium 4-hydroxybenzenesulfonate has a molecular weight of 196.2 g/mol, which does not favour dermal absorption. With high degree of solubility in water (92.4 g/L) and low partition coefficient (Log Pow -2.79), dermal uptake is expected to be low as Sodium 4-hydroxybenzenesulfonate can be considered to be too hydrophilic in nature to cross the lipid rich environment of the stratum corneum.The surface tension of 72.41 mN/m for Sodium 4-hydroxybenzenesulfonate also suggests a low dermal uptake from skin surfaces.
Sodium 4-hydroxybenzenesulfonate is neither corrosive nor irritating to the skin. However, it did lead to slight irritation on the skin of exposed rabbits which was reversed (within 72 hours in one animal and within 24 hours in remaining two animals). Toluene-4-sulfonic acid was not sensitising to the skin of guinea pigs. sodium xylenesulfonate was found to induce epidermal hyperplasia in a 90-day dermal toxicity study conducted in mice, however, no systemic toxic effects were reported in the study (NIH, 1998). Hence, taking into consideration the hydrophilic nature and absence of systemic signs in the dermal toxicity studies, Sodium 4-hydroxybenzenesulfonate is expected to have minimal absorption potential via dermal route.
Respiratory absorption:
Sodium 4-hydroxybenzenesulfonate exists as a solid and expected to have low volatility based on high melting point of >350°C, and hence may not be available in inhalable forms. Further, the high water solubility (92.4 g/L), indicates that the dust will be trapped in the mucus if it happens to enter the respiratory tract, thereby further limiting the absorption. No toxicity studies via inhalation route are available for Sodium 4-hydroxybenzenesulfonate or structurally similar substances. Nonetheless, taking into account the physicochemical properties, respiratory absorption potential of Sodium 4-hydroxybenzenesulfonate is considered to be poor.
Distribution
The available toxicological information does not provide any clear indication of a mechanism for distribution. However, being a hydrophilic substance, systemic distribution of Sodium 4-hydroxybenzenesulfonate will be limited by the rate at which it crosses cell membranes. Access to the central nervous system (CNS) or testes is likely to be restricted by the blood-brain and blood-testes barriers. Accumulation in body fat is unlikely to occur.
Metabolism
In the available toxicity and/or genetic toxicity studies with Sodium 4-hydroxybenzenesulfonate, there was no evidence to suggest that the test substance may be metabolised. Further, the high water solubility of Sodium 4-hydroxybenzenesulfonate suggests that metabolism would be limited and not required to facilitate renal excretion.
Excretion
Route of excretion for Sodium 4-hydroxybenzenesulfonate has not been investigated. However owing to the hydrophilic nature of the substance, it is expected to be predominantly excreted via urine.
Description of key information
Sodium 4-hydroxybenzensulfonate would be absorbed primarily in gastrointestinal tract, while poor absorption via dermal and inhalation exposure is expected. Systemic distribution would most likely be restricted owing to the hydrophilic nature, while metabolism would be limited and it will be predominantly excreted via urine.
Key value for chemical safety assessment
Additional information
Absorption
Oral/gastrointestinal absorption:
Based on the molecular weight of 196.2g/mol, Sodium 4-hydroxybenzensulfonate, is expected to favour oral absorption. With the high water solubility of 92.4 g/L, Sodium 4-hydroxybenzensulfonate may readily dissolve into the gastrointestinal fluids and be absorbed via passive diffusion.
Sodium 4-hydroxybenzensulfonate and structurally similar sodium xylenesulfonate were found to be of low acute oral toxicity. Toluene-4-sulfonic acid did not lead to test substance related adverse effects, as NOAEL was adjudged to be >500 mg/kg bw/day, the highest tested dose in the 28-day oral toxicity study. However, sodium xylenesulfonate was determined to have a NOAEL of 763 mg a.i./kg bw/day in a 90-day oral feeding study conducted in rats, as the LOAEL was determined to be 4092 mg a.i./kg bw/day (next and highest dose tested) on the basis of relative spleen weight loss in males seen at this dose level.
The findings from the repeated dose toxicity study with sodium xylenesulfonate were indicative of absorption taking place from the gastrointestinal tract, which can be considered to be the case with Sodium 4-hydroxybenzensulfonate as well.Hence, on the basis of hydrophilic nature and the findings of the toxicological studies as discussed above, Sodium 4-hydroxybenzensulfonate is expected to be absorbed by the gastrointestinal tract when administered orally.
Dermal absorption:
Sodium 4-hydroxybenzensulfonate has a molecular weight of 196.2 g/mol, which does not favour dermal absorption. With high degree of solubility in water (92.4 g/L) and low partition coefficient (Log Pow -2.79), dermal uptake is expected to be low as Sodium 4-hydroxybenzensulfonate can be considered to be too hydrophilic in nature to cross the lipid rich environment of the stratum corneum. The surface tension of 72.41 mN/m for Sodium 4-hydroxybenzensulfonate also suggests a low dermal uptake from skin surfaces.
Sodium 4-hydroxybenzensulfonate is neither corrosive nor irritating to the skin. However, it did lead to slight irritation on the skin of exposed rabbits which was reversed (within 72 hours in one animal and within 24 hours in remaining two animals). Toluene-4-sulfonic acid was not sensitising to the skin of guinea pigs. Sodium xylenesulfonate was found to induce epidermal hyperplasia in a 90-day dermal toxicity study conducted in mice, however, no systemic toxic effects were reported in the study (NIH, 1998). Hence, taking into consideration the hydrophilic nature and absence of systemic signs in the dermal toxicity studies, Sodium 4-hydroxybenzensulfonate is expected to have minimal absorption potential via dermal route.
Respiratory absorption:
Sodium 4-hydroxybenzensulfonate exists as a solid and expected to have low volatility based on high melting point of >350 °C, and hence may not be available in inhalable forms. Further, the high water solubility (92.4 g/L), indicates that the dust will be trapped in the mucus if it happens to enter the respiratory tract, thereby further limiting the absorption. No toxicity studies via inhalation route are available for Sodium 4-hydroxybenzensulfonate or structurally similar substances. Nonetheless, taking into account the physicochemical properties, respiratory absorption potential of Sodium 4-hydroxybenzensulfonate is considered to be poor.
Distribution
The available toxicological information does not provide any clear indication of a mechanism for distribution. However, being a hydrophilic substance, systemic distribution of Sodium 4-hydroxybenzensulfonate will be limited by the rate at which it crosses cell membranes. Access to the central nervous system (CNS) or testes is likely to be restricted by the blood-brain and blood-testes barriers. Accumulation in body fat is unlikely to occur.
Metabolism
In the available toxicity and/or genetic toxicity studies with Sodium 4-hydroxybenzensulfonate, there was no evidence to suggest that the test substance may be metabolised. Further, the high water solubility of Sodium 4-hydroxybenzensulfonate suggests that metabolism would be limited and not required to facilitate renal excretion.
Excretion
Route of excretion for Sodium 4-hydroxybenzensulfonate has not been investigated. However owing to the hydrophilic nature of the substance, it is expected to be predominantly excreted via urine.
CONCLUSION
Based on the above discussion, it can be concluded that Sodium 4-hydroxybenzensulfonate would be absorbed primarily in gastrointestinal tract, while poor absorption via dermal and inhalation exposure is expected. Systemic distribution would most likely be restricted owing to the hydrophilic nature, while metabolism would be limited and it will be predominantly excreted via urine.
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.