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EC number: 241-602-5 | CAS number: 17625-03-5
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted on 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium hydrogen m-sulphonatobenzoate
- EC Number:
- 241-602-5
- EC Name:
- Sodium hydrogen m-sulphonatobenzoate
- Cas Number:
- 17625-03-5
- Molecular formula:
- C7H6O5S.Na
- IUPAC Name:
- sodium 3-sulfobenzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- White crystalline powder.
Constituent 1
- Specific details on test material used for the study:
- Identity Sodium 3-sulfobenzoate
Alternative names 3-Sulpho Benzoic AcidMono Sodium Salt
SBA (3-Sodiosulfobenzoic Acid)
Sodium hydrogen m-sulphonatobenzoate
Label name 3-Sodiosulfobenzoic Acid
Batch no. 170103
Retest date 14 February 2019
Storage conditions Room temperature
RTC number 15432
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal supply and acclimatisation
Species and strain: Rat, Hsd:Sprague Dawley SD
Sex Females (nulliparous and non-pregnant)
Age 6 to 7 weeks old
Supplier Envigo RMS s.r.l., San Pietro al Natisone (UD), Italy
Breeder Envigo RMS B.V., Kreuzelweg 53, 5961 NM Horst, Netherlands
Date of arrival 19 July 2017
Weight range at arrival 169.8-173.5 grams
Acclimatisation period At least 5 days
Veterinary health check During acclimatisation period
Animal husbandry
Animals per cage Up to 4 during the study; up to 5 during acclimatisation
Housing Polisulfone solid bottomed cages measuring 59.5×38×20 cm with nesting material provided into suitable bedding bags
Cage control Daily inspected and changed as necessary (at least 2 times/week)
Water drinking water supplied to each cage via a water bottle
Water supply ad libitum
Diet 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)
Diet supply ad libitum throughout the study except for the dosing procedure
Room lighting Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes Approximately 15 to 20 air changes per hour
Temperature range 22 °C ± 2 °C
Relative humidity range 55% ± 15%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% aqueous solution of carboxymethylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5 % aquueous solution
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: According to the properties of the test item, it may be dissolved/suspended in a 0.5% aqueous solution of carboxymethylcellulose or in other vehicles (i.e. distilled water, a vegetable or mineral oil).
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Initial sighting study: one female for 2000 mg/kg
Main study: four females for 2000 mg/kg - Control animals:
- no
- Details on study design:
- Mortality and morbidity
Throughout the study all animals were checked twice daily.
Clinical signs
Animals were observed for clinical signs as indicated below:
– Day of dosing
· Session 1: on dosing
· Session 2: approximately 0.5 hour after dosing
· Session 3: approximately 2 hours after dosing
· Session 4: approximately 4 hours after dosing
– Daily thereafter for a total of 14 days (Session 1).
Body weight
All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15.
Body weight change calculated for Days 2, 8 and 15 of the dosing phase was relevant to Day 1 of the phase.
Termination
All animals were sacrificed on Day 15.
Euthanasia method
All animals were sacrificed on Day 15.
Necropsy procedure
Necropsy was carried out on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the gastro-intestinal tract).
Results and discussion
- Preliminary study:
- An initial sighting study was performed on a single female animal which was dosed at 2000 mg/kg. No mortality occurred and the animal was observed for a period of 14 days.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs were noted during the observation period in all animals treated.
- Gross pathology:
- No abnormalities were observed at the necropsy examination performed on termination of the observation period in the sighting study animal and in all animals of the main study.
- Other findings:
- No other findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The lack of mortality demonstrates that the LD50 of the substance is greater than 2000 mg/kg body weight.
- Executive summary:
The acute toxicity of Sodium 3-sulfobenzoate was investigated, according to OECD Guideline 420, following a single oral administration (10 mL/kg of an aqueous solution containing sodium 3-sulfobenzoate, 200 mg/mL and carboxymethylcellulose 0.5%, corresponding to 2000 mg/kg of Sodium 3-sulfobenzoate) to the Sprague Dawley rat followed by a 14-day observation period.
Mortality did not occur and no clinical signs considered related to the treatment were observed in the animals following dosing at 2000 mg/kg.
These results indicate that the test item, Sodium 3-sulfobenzoate, has no toxic effect on the rat following oral administration of a single dose at 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.
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