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EC number: 244-584-7 | CAS number: 21799-87-1
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 November 2017 to 31 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down 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:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Potassium 2,5-dihydroxybenzenesulphonate
- EC Number:
- 244-584-7
- EC Name:
- Potassium 2,5-dihydroxybenzenesulphonate
- Cas Number:
- 21799-87-1
- Molecular formula:
- (HO)2C6H3SO3K
- IUPAC Name:
- potassium 2,5-dihydroxybenzenesulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: The Dow Chemical Company, Midland, Michigan (United States)
- Lot No.of test material: YY00G7P285
- Expiration date of the lot/batch: 17 December 2017
- Purity test date: Not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature
- Stability under test conditions: Not determined, assumed stable for the duration of the study
- Solubility and stability of the test substance in the solvent: soluble on Reverse Osmosis water at 200 mg/L. Stability, uniformity of mixture and verification of concentration of the test item in its carrier, was not determined.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: None
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Adminstered undiluted, as received. Test item pre-mixed with Reverse Osmosis water to a concentrstion of 200 mg/mL.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- (RCCHan:WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: Minimum: 189.4 - 213.7g
- Fasting period before study: yes, fasted overnight prior to dosing and until three hours post-dosing.
- Housing: Rats were housed individually in standard polypropylene solid bottom cages which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). These cages have stainless steel top grills with steam sterilized corn cob bedding material. Rack units were rotated once a week.
- Diet (e.g. ad libitum): Teklad certified global high fiber rat pellet feed manufactured by Envigo, USA
- Water (e.g. ad libitum): UV sterilized water filtered through Reverse Osmosis water filtration system
- Acclimation period: 6 to 16 days prior to commencement of dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23 °C
- Humidity (%): 49 to 66% relative humidity
- Air changes (per hr): 17 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h which was maintained through an automatic timer.
IN-LIFE DATES: From: To: 1 December 2017 to 31 December 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Reverse Osmosis
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): Dose volume (10 mL/kg body weight).
- Justification for choice of vehicle: Based on solubility to 200 mg/mL in RO water to acheive a limit concentration of 2000 mg K-Salt/kg body weight when dosed at 10 ml/kg bw
- Lot/batch no. (if required): Not specifed
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- The study was performed as a limit test at a dose level of 2000 mg K-Salt/kg body weight.
- No. of animals per sex per dose:
- Total Number of Animals Used: Five females (nulliparous and non-pregnant)
The first rat was given a single dose of 2000 mg K-Salt/kg bw. No mortality was observed at this dose level up to 48 hours post dose. Therefore, rat No's 2, 3, 4 and 5 were treated with the same dose level of 2000 mg K-Salt/kg bw, one at a time, separated by minimum of 48 hours post dosing intervals. All rats survived at the dose level of 2000 mg K-Salt/kg bw. As the end point was achieved, no further testing was required. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days following oral dosing
- Frequency of observations and weighing: Rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 6 hours post-administration on the day of dosing. Subsequently, rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing.
- Necropsy of survivors performed: yes, at study termination all rats were humanely euthanised by carbon dioxide asphyxiation and subject to a gross pathological examination consisting of an external examination and opening of abdominal and thoracic cavities. The stomach of each rat was opened, the contents rinsed/removed, and the mucosal surface was examined for signs of irritation, erosions, ulcers or any other findings.
- Other examinations performed: Clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 1, and on days 8 and 15. - Statistics:
- The LD50 was calculated using the Dixon’s maximum likelihood method using software (AOT 425 StatPgm) and was estimated to be greater than 2000 mg K-Salt/kg body weight in female Wistar rats.
ref: AOT 425 StatPgm (OECD), Acute Oral Toxicity (Guideline 425) Statistical Program, Version 1.0, May 2001.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in any rat after a single dose of 2000 mg K-Salt/kg body weight and observed for 14 days
- Clinical signs:
- other: No signs of toxicity were observed in rats treated with K-Salt at 2000 mg/kg body weight and observed for 14 days
- Gross pathology:
- External and visceral examination of terminally sacrificed rats did not reveal any lesions of pathological significance. In absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose level used in the present study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral estimated LD50 of the K-Salt was estimated to be greater than 2000 mg/kg body weight in female Wistar rats.
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