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Diss Factsheets
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EC number: 939-154-7 | CAS number: -
- 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
Description of key information
LD50 oral > 2000 mg/kg bw
LD50 dermal > 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study under GLP condition
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Vehicle:
- other: distilled water
- Doses:
- 0, 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Interpretation of results:
- practically nontoxic
- Remarks:
- Criteria used for interpretation of results: EU
Reference
[Mortality / Clinical signs]
No deaths occurred during the study.Diarrhea was observed for both sexes in the 2000 mg/kg bw groups.
[Body weight]
There were no treatment-related changes in body weight in either sex.
[Necropsy]
No macroscopic abnormalities were observed at autopsy in either sex.
LD50 in male and female rats were greater than 2000 mg/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The datatbase contains good studies on sodium sulphate, two studies on the acid form of hydroxybenzenesuphonate of very low reliability, several studies on acid and salt form of analogues substances. All studies are consistent and reveal a low toxicity for all components.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Clinical signs:
- other:
Reference
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:
- weight of evidence
- Study period:
- April 7-21, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline test; GLP compliance, full documentation
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products, Michigan
- Age at study initiation: 5 months
- Weight at study initiation: nakes 2944-3091g and females 2915-3155g
- Fasting period before study: no data
- Housing: individually in hanging stainless steel wire mesh cages
- Diet: up to 125 g/day
- Water: ad libitum
- Acclimation period: minimum of 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but no values reported
- Humidity (%): controlled but no values reported
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- other: The animals were maintained in accordance with the recommendations contained in the D.H.H.S. Publication "Guuide for the Care and Use of Laboratory Animals".
IN-LIFE DATES: From: April 7 To: April 21 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day prior to dosing, the hair was removed from the back of each rabbit with an electric clipper. The skin was left intact. The test material was applied once, as received, at a dose of 2000 mg/kg then spread evenly to cover 100% of the test site which was approximately 10% of the body surface. The test site was covered with a 1 x 1 inch gauze pad, wrapped with a gauze bandage, overwrapped with plastic wrap and then sealed with elastoplast tape. A collar was placed on each animal. The test site was washed 24 hours later with water and towel dried.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/Kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 1,2 and 4 hours on day one then twice daily for the next 13 days. weighing prior to dosing, on day 8 and at study termination.
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacotoxic signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- none
- Clinical signs:
- other: 4 of the 10 animals displayed no visible abnormal signs. Erythema was noted on day 3 in six animals with desquamation additionally obsserved on day 9 in one animal.
- Gross pathology:
- No visible abnormalities in 6 of the 10 animals. The remaining 4 displayed focal or multifocal red discoloration of the treated skin with one animal additionally displaying desquamation of the same site.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The dermal LD50 is > 2000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The database is constituted by consistent tests whith different sample, different date and methods, therefore in the whole the quality is good
Additional information
Acute Oral toxicity
The database contains good studies on sodium sulphate, two studies on the acid form of hydroxybenzenesuphonate of very low reliability, several studies on acid and salt form of analogues substances. All studies are consistent and reveal a low toxicity for all components. The studies with the acid form reveal some effects due to the corrosive nature of the substance and not to the intrinsic systematic acute toxicity, therefore the results are taken into account just as indicative values.
Acute inhalatory toxicity
No specific and reliable studies are available. A waiving justification is reported. Some indication of very low toxicity is given by literature studies with low reliability.
Dermal toxicity
There are acute dermal toxicity studies for closely related hyrotropes, salt form of the sulphonic acids. The LD50 for the salts is >2000 mg/kg bw.
Justification for selection of acute toxicity – dermal endpoint
The study is the only GLP study and the better reported
Justification for classification or non-classification
No basis for acute toxicity classification is found.
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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