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EC number: 232-439-0 | CAS number: 8029-68-3 A complex product obtained by the sulfonation and ammoniation of the distillation product from bituminous schists. It may contain saturated and unsaturated hydrocarbons, nitrogen bases and thiophene derivatives.
- 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
Toxicity to microorganisms
Administrative data
- Endpoint:
- toxicity to microorganisms, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of study: March 22nd, 1995
Termination of study: March 23rd, 1995 - Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- DIN 38412-8 (Pseudomonas Zellvermehrungshemmtest)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ichthammol
- EC Number:
- 232-439-0
- EC Name:
- Ichthammol
- Cas Number:
- 8029-68-3
- Molecular formula:
- unspecified
- IUPAC Name:
- Ichthammol (UVCB substance)
- Test material form:
- liquid: viscous
- Details on test material:
- sample from a batch from regular production released for use as an active pharmaceutical ingredient in medicinal products.
1
- Specific details on test material used for the study:
- The test substance was taken from a regular production batch of the registrant's manufacturing site (Ichthyol batch no. R 954623). Ichthyol is a trademark name for Ichthammol. A certificate of analysis is part of the study report. Release of raw material was done according to provisions of different pharmacopoeias (ÖAB, PH.EUR and DAB 10, respectively).
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Test solutions consisted of inoculation medium, stock solutions and test substance solution. For preparation of the different solutions aqua dest. was used.
Test organisms
- Test organisms (species):
- Pseudomonas putida
- Details on inoculum:
- One day old stock cultures of Pseudomonas putida served as inocula for preliminary cultures. Using aseptic techniques, suspensions of bacteria in preliminary culture medium (stock solution I, III, IV; 2.5 ml stock solution I, 2.5 ml stock solution III, 5.0 ml stock solution IV; see below) were diluted to a concentration corresponding a turbidity value of TU/F = 10 (turbidity units formazin).
Stock solution I
10.0 g sodium nitrate, NaNO3;
2.4 g dipotassium hydrogen phosphate, K2HPO4
1.2 g potassium dihydrogen phosphate, KH2PO4
1.0 g yeast extract
in 500 ml aqua dest.
Stock solution II
10.0 g sodium nitrate
2.4 g dipotassium hydrogen phosphate
1.2 g potassium dihydrogen phosphate
in 500 ml aqua dest.
Stock solution III
44.0 g D(+)-glucose-monohydrate
in 500 ml aqua dest.
Stock solution IV
0.01 g ferrous citrate, w(Fe) = 19%
4.0 g magnesium sulphate, heptahydrate
in 1000 ml aqua dest.
250-ml Erlenmeyer flasks were each filled with 100 ml of suspension. The bacteria were incubated at 20°C - 21°C for about 7 hours. Thereafter the cultures were mixed and adjusted with further preliminary culture medium to an extinction value of 0.168 (TU/F = 50 ± 1). This suspension served as inoculation medium for the test.
Four parallel dilution series in 250-ml Erlenmeyer flasks with sterile stoppers were prepared with a final volume of 100 ml test medium each. Three series were inoculated with bacteria. The fourth series was not inoculated and served as a blank.
The final volume consisted of 10 ml of the inoculation medium (or 10 ml of preliminary culture medium for the fourth series which was not inoculated), 10 ml of stock solutions (2.5 ml stock solution II, 2.5 ml stock solution III, 5.0 ml stock solution IV; cf Appendix 1) and 80 ml of the test substance solution. The dilution factor was 2.0. The bacterial concentration at start corresponded to a turbidity value of TU/F = 5. The pH was 6.88 to 6.95.
Four control culture flasks with 80 ml sterile water, 2.5 ml stock solution II, 2.5 ml of stock solution III, 5 ml of stock solution IV and 10 ml of the prepared bacterial solution (3 flasks) or 10 ml of preliminary culture medium (1 flask) were also included.
Both inoculated and non-inoculated (see above) dilution series as well as the control culture flasks were left at 20°C - 21°C in the dark for 16 ± 1 hours (shaker; 75 - 85 rpm).
After termination of the test period the extinction of the monochromatic light at 436 nm was measured in a 10-mm cell with samples from the four test substance flasks per concentration and the control flasks. Since turbidity occurred in the dilution series for chemical-physical reasons, the analogous steps of dilution of the non-inoculated series were used as photometric blank values for the turbidity of the inoculated dilution series.
In a preliminary test the bacteria culture was exposed to concentrations of 100, 316, 1000 and 3160 mg/ml. No growth inhibition was seen up to a concentration of 316 mg/l, distinct and increasing growth inhibition was observed at concentrations of 1000 and 3160 mg/ml. Hence concentrations of 313, 625, 1250, 2500, 5000 and 10000 mg/l were used for the main test.
Study design
- Test type:
- static
- Water media type:
- other: The water media type follows the provisions of the method: surface, ground, or waste water to be tested
- Limit test:
- no
- Total exposure duration:
- 16 h
Test conditions
- Hardness:
- not applicable
- Test temperature:
- 20°C - 21°C
- pH:
- Initial pH of all test compound solutions and the control solution: 6.88 - 6.94
- Dissolved oxygen:
- not applicable
- Salinity:
- not applicable
- Conductivity:
- not applicable
- Nominal and measured concentrations:
- Nominal concentrations apply according to study report information. Preparation of the inoculation medium is described accordingly.
- Details on test conditions:
- Both inoculated and non-inoculated (see above) dilution series as well as the control culture flasks were left at 20°C - 21°C in the dark for 16 ± 1 hours (shaker; 75 - 85 rpm).
- Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 16 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1 824 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 16 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3 520 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 16 h
- Dose descriptor:
- EC100
- Effect conc.:
- 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Details on results:
- After termination of the test period the extinction of the monochromatic light at 436 nm was measured in a 10-mm cell with samples from the four test substance flasks per concentration and the control flasks. Since turbidity occurred in the dilution series for chemical-physical reasons, the analogous steps of dilution of the non-inoculated series were used as photometric blank values for the turbidity of the inoculated dilution series.
- Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- The following values were calculated
(i) mean extinction value of the control cultures
(ii) mean extinction values of each concentration of the inoculated dilution series
The mean extinction values of each dilution step were plotted against the logarithm of the values of the concentration of the test substance. The extinction values were measured against the non-inoculated series.
The inhibitory effect on cell multiplication (H) was calculated as follows for each tested concentration:
H = (Bc - Bn)/(Bc - B0)
whereas H = inhibitory effect on cell multiplication, in %
Bc = Biomass in the control at the end of the test
Bn = Biomass of the nth concentration at the end of the test
B0 = Biomass of the control at time t0
From the different series the mean was calculated together with the standard deviation.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- IchthyolR was investigated for its ability to inhibit the cell multiplication of the bacteria species Pseudomonas putida according to DIN 38 412 L-8. Cultures of the bacteria were exposed to concentrations ranging from 313 mg to 10000 mg IchthyolR/l.
Under the present test conditions no inhibition of cell multiplication of the bacteria species Pseudomonas putida was observed at concentrations of 313 and 625 mg Ichthyol/l. At concentrations ranging from 1250 to 10000 mg/l a distinct and concentration-related inhibition of cell multiplication was observed.
The following parameters were determined for Pseudomonas putida:
EC10 (16 h) : 1824 mg Ichthyol/I
EC50 (16 h) : 3520 mg Ichthyol/l
EC100 (16 h) : 10000 mg Ichthyol/l.
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