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EC number: 215-671-7 | CAS number: 1340-06-3
- 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:
- November to December 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- In the study report no reference to the above mentioned guideline is made.
- Deviations:
- not specified
- Remarks:
- LD50 was determined to be > 10000 mg/kg b.w. (males and females)
- Principles of method if other than guideline:
- The test substance was administered orally by gavage in graduated doses to three groups
of experimental animals (rats), one dose being used per group. Subsequently observations of effects were made as long as four weeks after administration of the test substance. Although the testing guideline is not mentioned in the study report, it is obvious that the principles of OECD guideline 401 were followed. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ichthyolic acid, sodium salt
- EC Number:
- 215-671-7
- EC Name:
- Ichthyolic acid, sodium salt
- Cas Number:
- 1340-06-3
- IUPAC Name:
- Identification of the UVCB substance by "Chemcial Abstracts Index Name", among others: Ichthyolic Acid, Sodium Salt. No IUPAC name known.
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- The test substance named "ICHTHYOL Natrium hell" with batch number 4 - 5/72 in the study report originated from regular production by ÖSTERREICHISCHE ICHTHYOL (applicant/registrant). Its identity corresponds to the one of ICHTHYOL PALE. At the time of conduct of the study it has been in clinical use in dermatology for several decades.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Sprague-Dawley rats originated from breeder S.IVANOVAS, 7967 Kißlegg/Württ., Germany. Their weight was between 100 and 105 g and their age was 38 days for male animals and 42 days for female animals at the begin of the study. The animals were kept singly in Makrolon cages (type II) at room temperature (24.0 +- 0.5°C) and a relative humidity of 60% +- 3%.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Feeding was discontinued 15-16 hours before administration of the test substance which was diluted with distilled water and administered once by gavage at a volume of 20 ml/kg b.w. Water was available to the animals ad libitum.
- Doses:
- 6,300/7,900/10,000 mg/kg b.w. (male and female)
- No. of animals per sex per dose:
- Five male and five female animals per dose.
- Control animals:
- no
- Details on study design:
- Mortality: no interval specified
Clinical signs: determined during the post-observation time of 4 weeks
General behaviour: determined during the post-observation time of 4 weeks
Body weights: determined during the post-observation time of 4 weeks
Food intake: determined during the post-observation time of 4 weeks
Necropsy: performed immediately after death of animals and at the end of the observation period on surviving animals - Statistics:
- Study was without statistical evaluation due to the fact that no lasting effects could be observed and the LD50 could not be determined (LD50 > 10000 mg/kg b.w. (males and females). Higher dosages could not be applied because corresponding volumina were too large.
Results and discussion
- Preliminary study:
- No preliminary study indicated in available study report.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Volumina higher than 10000 mg/kg b.w. could not be applied.
- Mortality:
- No mortalities
- Clinical signs:
- Signs of slight sedation after administration of 7900 mg/kg b.w.; after 10000 mg/kg b.w. slight sedation and ataxia was observable. Total recovery within 24 hours, no lasting effects.
- Body weight:
- No changes in body weight development and food intake was observable.
- Gross pathology:
- On necropsy no specific pathological findings were evident (number and kind of organs not specified).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of Ichthyolic Acid, Sodium Salt (ICHTHYOL PALE) in rats was found to be above 10000 mg/kg b.w.
- Executive summary:
The acute oral toxicity in rats was determined according to a method comparable to procedures described in OECD guideline 401 "Acute Oral Toxicity" (adopted 24 Feb 1987).
All animals survived the treatment and showed only slight signs of sedation after administration of 7900 mg/kg b.w. and slight sedation and ataxia after 10000 mg/kg b.w. All animals recovered within 24 hours. On necropsy no specific pathological findings were evident.
Under the experimental conditions described in this report, the oral LD50 of ICHTHYOL Natrium hell (identity corresponding to ICHTHYOL PALE as a synonym of Ichthyolic Acid, Sodium Salt) in rats was found to be above 10000 mg/kg b.w.
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