Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 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
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- start of study: 28 June 1993
termination of study: 2 July 1993 - Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- OECD Method No. 203 dated April 4th, 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- Test substance originated from a regular production batch R 92/0541. The description "sulfonated shale oil, pale" for the test substance (as mentioned in the study title) is a common general expression/identifier for ICHTHYOL PALE.
Sampling and analysis
- Analytical monitoring:
- not required
- Remarks:
- No analysis of samples was conducted as ICHTHYOL PALE (sulfonated shale oil, pale) is known to be stable as an aqueous solution.
- Details on sampling:
- Samples were taken both at the start and the end of the study (after 4 days exposure period) from the tanks of all the concentrations and the control and were stored at LPT (testing facility) at -20°C or colder. However, no analysis of the samples was conducted as ICHTHYOL PALE (sulfonated shale oil, pale) is known to be stable as an aqueous solution.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test substance was used as supplied. The following concentrations of ICHTHYOL PALE were employed in the exposure medium: 2.37 mg, 4.21 mg, 7.48 mg, 13.30 mg and 23.70 mg per litre. The concentration interval factor was 1.78. The concentrations chosen were based on a preliminary test.
Test organisms
- Test organisms (species):
- Leuciscus idus
- Details on test organisms:
- Gold orfe/Leuciscus idus (fry of about 6.0 +- 2.0 cm were selected)
breeder: Fischzucht EGGERS, Martensweg 18, D-24594 Hohenwestedt, Germany
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- Concentration of minerals:
CCaCl2: 2 mmol/l
MgSO4: 0.50 mmol/l
NaHCO3: 0.77 mmol/l
KCl: 0.077 mmol/l
The sum of calcium and magnesium ions was 2.5 mmol/l, the proportion of Ca:Mg ions was 4:1 and of Na:K ions 10:1.
The acid capacity was about 0.8 mmol/l.
The total hardness was equivalent to 250 mg CaCO3/l.
The total alkalinity was about 0.8 mmol/l. - Test temperature:
- 21.1°C - 21.4°C (measured daily)
- pH:
- 7.50 - 8.04 (measured daily)
- Dissolved oxygen:
- O2-concentration: 80.7% - 99.4% of the air saturation value.
- Salinity:
- not applicable
- Conductivity:
- not measured
- Nominal and measured concentrations:
- The substance is readily soluble and stable in water. Nominal concentrations, therefore, can be assumed to be in line with actual concentrations.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass tank
- Material, size, headspace, fill volume: 10 l (l x w x h = 290 mm x 190 mm x 195 mm)
- Aeration: by Pasteur pipettes (Kroll, 22525 Hamburg) at a rate of 2 to 3 air bubbles per second
- Renewal rate of test solution (frequency/flow rate): water changed after 48 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Total organic carbon: n.d.
- Particulate matter: n.d.
- Metals: n.d.
- Pesticides: not applicable
- Chlorine: not indicated
- Alkalinity: ca. 0.8 mmol/l
- Ca/Mg ratio: 4:1
- Culture medium different from test medium: not applicable
- Intervals of water quality measurement: not indicated
OTHER TEST CONDITIONS
- Adjustment of pH: daily measurement of pH
- Photoperiod: 16 h photoperiod daily
- Light intensity: not indicated
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Assessment of the behaviour, appearance and mortality of the fish was carried out at the beginning of the study, after 5, 15 and 30 minutes and 1, 3, 6, 24, 48, 72 and 96 hours after start of the exposure.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.78
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study: preliminary test with 0 to 376 mg/l exposure medium
- Test concentrations: 2.37/4.21/7.48/13.30/23.70 mg/l exposure medium - Reference substance (positive control):
- no
Results and discussion
Effect concentrations
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Remarks:
- The nominal LC50 (50% mortality of the fish after 96 hours) was calculated by linear regression analysis.
- Effect conc.:
- 7.58 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mortality (fish)
- Details on results:
- No toxic effects by Ichthyol Pale were observed at a concentration of 2.37 mg/l exposure medium (NOEC). First intolerance reactions were observed at a concentration of 4.21 mg/l exposure medium; two animals remained predominantly at the water surface with a marked oblique position and markedly increased gill breathing in a third animal out of 10 animals 24 hours after start of exposur, after 72 hours 2 animals and after 96 hours 1 animal were predominantly at the water surface. At this concentration 1 out of 10 animals died after 96 hours exposure.
The lowest lethal concentration for fish was 4.21 mg Ichthyol Pale/l exposure medium. The LC50 (96 h) was calculated as 7.58 mg Ichthyol Pale/l exposure medium.
Tested animals showed no change in the length and body weight at termination of the study compared to the 10 untreated animals. - Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- The nominal LC50 (50% mortality of the fish after 96 hours) was calculated by linear regression analysis. The 95%confidence limits were determined according to FINNEY.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of Ichthyolic Acid, Sodium Salt in fish (Leuciscus idus) was tested by means of trademark substance ICHTHYOL PALE in a semistatic test system according to OECD Method No. 203 (dated April 4th, 1984) in a test period of 96 hours.The threshold level of observed as well as lethal effects was determined to be 4.21 mg test substance/l exposure medium. The NOEC was determined to be at a concentration of 2.37 mg/l exposure medium. The LC50 was calculated by linear regression to be 7.58 mg/l exposure medium.
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.