Registration Dossier
Registration Dossier
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: 204-317-7 | CAS number: 119-36-8
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- data not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well described following scientific principles. No GLP. No data on purity.
Data source
Reference
- Reference Type:
- publication
- Title:
- Bio-distribution in rats of some salicylates with low gastric ulcerogenicity.
- Author:
- Rainsford KD, Schweitzer A, Green P et al
- Year:
- 1 980
- Bibliographic source:
- Agents and Actions, 10(5), 457-464.
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The distribution and metabolism of radioactively labelled test substance was investigated using whole body autoradiography and chemical analyses following oral administration.
- GLP compliance:
- no
Test material
- Reference substance name:
- Salicylic acid
- EC Number:
- 200-712-3
- EC Name:
- Salicylic acid
- Cas Number:
- 69-72-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- 2-Hydroxybenzoic acid
- Details on test material:
- Test substance: salicylic acid (SA)
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tierfarm, Tuttlingen, FRG
- Age at study initiation: no data
- Weight at study initiation: 100-130 g
- Fasting period before study: no data
- Housing: no data
- Individual metabolism cages: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sterile saline
- Details on exposure:
- Male Sprague-Dawley rats were inoculated with 0.05 ml 2% W/v carrageenan in sterile saline in the left rear paws to elicit an acute (local) inflammatory reaction. An injection of 0.05 ml sterile saline into the right rear paw served as control. The animals were then dosed orally with 1 ml aqueous fine suspensions of the radioactively labelled salicylic acid which were prepared immediately beforehand to minimize degradation.
- Duration and frequency of treatment / exposure:
- 180 minute(s)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Males: 10 and 100 mg/kg
- No. of animals per sex per dose / concentration:
- no data
- Control animals:
- not specified
- Positive control reference chemical:
- no data
- Details on study design:
- - Dose selection rationale: no data
- Details on dosing and sampling:
- Blood samples (50-100 µl) were collected from one of the tail veins at 10 and 60 min after dosing and finally (on termination under ether anaesthesia at 180 min) from one of the carotid arteries or veins. The blood samples were assayed for total radioactive content following total combustion. After collection of the final blood sample the rats were bled as nearly as possible to completion, the carcasses shaved and rapidly frozen in a hexane-dry ice mixture. Whole body autoradiography was then prepared.
- Statistics:
- Nostatistics were performed
Results and discussion
- Preliminary studies:
- No preliminary studies were performed.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Following oral administration of radioactively labelled salicylic acid, the test substance was found in blood. The results are essentially qualitative because the varying dose levels employed were adjusted to account for the specific activity of the substance.
- Details on distribution in tissues:
- Salicylic acid was found in the stomach, liver, kidney lungs, bone marrow, intestine, inflamed paws and spleen.
- Details on excretion:
- not examined
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Small quantities of salicylic acid and 2,5-dihydroxybenzoic acid were present in the blood of rats dosed with salicylic acid.
Any other information on results incl. tables
The methyl ester of ASA (AME) was distributed in vivo very similarly to that observed with ASA and salicylic acid.AMEis rapidly demethylated following absorption from the stomach and is subsequently converted to ASA and salicylate. Salicylate is the main metabolite produced from both AMEand ASA, which specifically accumulates in inflamed tissues.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
Under the conditions of this test, after oral administration salicylic acid passed into the blood and was distributed into several organs of the body. - Executive summary:
In this study (Rainsford et al., 1980), bio-distribution in rats of salicylic acid with low gastric ulcerogenicity was examined. The distribution and metabolism of the radioactively labelled salicylic acid (SA) was evaluated after oral gavage administration using whole body autoradiography and chemical analyses. Results show that salicylic acid is absorbed as it was rapidly found in blood. Moreover, salicylic acid is distributed in several organs in the body. Qualitative organ distribution of radioactivity : ASA (100 mg/kg): Non glandular mucosa of stomach = kidneys = inflamed paws > lungs > glandular mucosa of stomach = liver = bone marrow = intestine. SA (10 and 100 mg/kg): Non glandular mucosa of stomach = inflamed paws > lungs > liver >= glandular mucosa of stomach = kidneys = bone marrow = intestine.
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.
