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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 9th, 1993 to March 21st, 1993 (end of experimental phase)
- 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:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- The study was performed according to the EEC guidelines L 251: part B: Methods for the Determination of Toxicity - Mutagnicity (Salmonella typhimurium - reverse mutation assay), dated September 19th, 1984, vol. 27, p. 143 and of the OECD Guidelines for Testing of Chemicals (No. 471, adopted 26 May 1983).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
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
Method
- Test concentrations with justification for top dose:
- In a preliminary experiment using strain TA 100 a cytotoxic effect was observed at 31.6 microliters and 100.0 microliters/plate. Hence it was decided to use 100.0 microliters test substance as the top concentration in the main study.
- Vehicle / solvent:
- Aqua ad iniectabilia served as solvent (negative) control.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Aqua ad iniectabilia served as solvent (negative) control.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Aqua ad iniectabilia served as solvent (negative) control.
- True negative controls:
- yes
- Remarks:
- Aqua ad iniectabilia served as solvent (negative) control.
- Positive controls:
- yes
- Remarks:
- with metabolic activation: sodium azide (in H2O), 2-nitrofluorene (in DMSO) and 9-aminoacridine (in ethanol) without metabolic activation: 2-aminoanthracene (in DMSO)
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene in DMSO (with metabolic activation)
- Details on test system and experimental conditions:
- The Salmonella typhimurium histidine (his) reversion system is a microbial essay which measures his- -> his+ reversion induced by chemicals which cause base changes or frameshift mutations in the genome of this organism.
- Evaluation criteria:
- A test chemical is considered to show a positive response if (i) the number of revertants is significantly increased (p <= 0.05, U-test) compared to the solvent control to at least 2-fold of the solvent control for TA 98 and TA 100 and 3-fold of the solvent control for TA 1535, TA 1537 and TA 1538 in both experiments, (ii) a significant (p <= 0.05) dose (log value)-related effect is observed, (iii) positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
- Statistics:
- A test chemical is considered to show a positive response if (i) the number of revertants is significantly increased (p <= 0.05, U-test according to MANN and WHITNEY see reference below) compared to the solvent control to at least 2-fold of the solvent control for TA 98 and TA 100 and 3-fold of the solvent control for TA 1535, TA 1537 and TA 1538 in both experiments, (ii) a significant (p <= 0.05) dose (log value)-related effect (Spearman's rank correlation coefficient, see reference below) is observed, (iii) positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
reference given for statistical evaluation (as mentioned above): COLQUHOUN, D., Lectures on Biostatistics, Clarendon Press, Oxford (1971)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight cytotoxic effect was observed at 31.6 microliter and 100.0 microliter/plate in a preliminary test. Hence 100.0 microliter/plate was chosen as top concentration for the main study.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight cytotoxic effect was observed at 31.6 microliters and 100.0 microliters/plate. Hence 100.0 microliters/plate was chosen as top concentration for the main study.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight cytotoxic effect was observed at 31.6 microliter and 100.0 microliter/plate in a preliminary test. Hence 100.0 microliter/plate was chosen as top concentration for the main study.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight cytotoxic effect was observed at 31.6 microliter and 100.0 microliter/plate in a preliminary test. Hence 100.0 microliter/plate was chosen as top concentration for the main study.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight cytotoxic effect was observed at 31.6 microliter and 100.0 microliter/plate in a preliminary test. Hence 100.0 microliter/plate was chosen as top concentration for the main study.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- No mutagenic effect was observed for ICHTHYOL PALE tested up to 100.0 microliter/plate in any of the tester strains in two independent experiments with and without metabolic activation.
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