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EC number: 811-484-5 | CAS number: 680972-33-2
- 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
There are 6 acute oral, 4 acute dermal and one acute inhalation studies, a number of which are guideline GLP studies, for different hydrotrope substances. By EU criteria these hydrotrope substance are deemed "practically non-toxic" for oral, dermal and inhalation exposure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 7 000 mg/kg bw
- Quality of whole database:
- Sufficient to meet requirements
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 6 410 mg/m³ air
- Quality of whole database:
- Sufficient to meet requirements
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to meet requirements
Additional information
There are a total of 11 acute toxicity studies on the hydrotrope category substances, six by the oral route, four by the dermal route and one by inhalation.
The key acute oral study is a 1982 study with sodium cumene sulphonate which follows OECD 401 guideline but not GLP. It is a limit test of 5 males and 5 females exposed at 7000 mg/kg bw . Two female rats died. There were some clinical signs of stress following dosing but all animals were free of clinical symptoms at 24 hours. There were no effects on body weights and no pathological changes at the 14 day necropsy. The LD50 was recorded as greater than 7000 mg/kg bw and per EU criteria the test substance was deemed "practically non-toxic". The other 5 oral studies show comparable results.
The key acute dermal toxicity is a 1968 study with sodium cumene sulphonate which is generally equivalent to OECD 402. It was a limit test. Six rabbits (3 with shaved and abraded skin and 3 with intact shaved skin) were exposed to 2000 mg/kg bw. There were no deaths but primary irritation was reported at the site of exposure. Body weights were normal at 14 days and there were no gross pathology or histopathology noted at sacrifice. The dermal LD50 is reported as >2000 mg/kg bw. The other three acute dermal studies reported comparable results.
The key acute inhalation study is a 1980 (non-GLP) study with ammonium xylene sulphonate. This is a 232-minute, limit test, involving exposure of male and female rats with no vehicle and a 14-day post exposure observation period. There were no deaths at the 6.41 mg/L dose. Aerosolization was done by a DeVilbiss Nebulizer and exposures were in glass chambers. One of the 10 animals demonstrated clinical signs (soft stool), 2 of the 10 had slight weight gains at days 7 and 14, and 5 of the 10 showed slight mottling or a moderate congestion of lungs at necropsy. The conclusion was reported as "practically nontoxic".
Justification for classification or non-classification
The available studies with oral, dermal and inhalation exposure demonstrate that the members of the hydrotrope category are of low acute toxicity. No classification is warranted.
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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