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EC number: 269-642-9 | CAS number: 68308-30-5
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 - 08 Feb 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 17 Jul 1992
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GYEMSZI, National Institute for Quality and Organizational Development in HealthCare and Medicine, Hungary (08 - 11 Oct 2012)
- Analytical monitoring:
- no
- Remarks:
- The test item concentrations could not be determined due to very low solubility in water (< LOQ).
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A saturated solution method was used to prepare test solutions because the test item is very poorly soluble in water. A supersaturated test item stock solution of 100 mg/L (nominal) was prepared by dispersing/dissolving the required test item in test medium (aquarium water) 2 d before the start of the study. This solution was shaken for 24 h at approximately 30 °C and then was equilibrated for about 24 h at test temperature. The non-dissolved test material was removed by filtration through a fine filter (0.22 µm) to give the 100% v/v saturated solution.
- Controls: Dilution water without test item (circulated, filtered and cooled). - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout
- Source: Hoitsy & Rieger Kft., Trout Farm, Miskolc-Lillafüred, Hungary
- Length at study initiation: 6.0 - 6.5 cm
- Calculated mean weight of 1 fish at study initiation: 2.79 g (control), 2.67 g (treatment). There was no considerable difference in body weights between the groups.
- Method of breeding: Fish were bred in a well-known fish farm, under disease- and parasite-controlled conditions. Fish were observed during the acclimatisation and test periods, the fish were healthy.
- Maintenance of the brood fish: Mortalities were < 5% of the population 7 d before the test.
ACCLIMATION
- Acclimation period: > 12 d
FEEDING DURING TEST
- Frequency: The fish were not fed during the test. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 203.5 mg/L as CaCO3
- Test temperature:
- 13.7 - 14.5 °C
- pH:
- 7.32 - 8.01
- Dissolved oxygen:
- 94 - 98% of the air saturation value
- Nominal and measured concentrations:
- 100% v/v saturated solution (nominal: 100 mg/L)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Aquaria filled with 20 L test solution
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 1.0 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: Daily (pH, temperature, oxygen saturation)
OTHER TEST CONDITIONS
- Photoperiod: 16 h light, 8 h dark
EFFECT PARAMETERS MEASURED:
- Mortality and sub-lethal effects: after 3, 6, 24, 48, 72 and 96 h
- Body weight: Before test start
TEST CONCENTRATIONS
- Range finding study : Yes
- Test concentrations: 0.1, 1, 10, and 100% v/v saturated solution
- Results used to determine the conditions for the definitive study: Yes, the test concentrations were selected on the basis of the results of the preliminary range-finding test: 0% mortality at 100% v/v saturated solution after 96 h. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- 100% v/v saturated solution
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- 100% v/v saturated solution
- Duration:
- 96 h
- Dose descriptor:
- LOELR
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- 100% v/v saturated solution
- Details on results:
- - Observations on body length at the end of the test: 6.0 - 6.4 cm (control), 6.1 - 6.5 cm (treatment)
- Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: No - Reported statistics and error estimates:
- No statistical analysis was performed because of the lack of toxic effects.
The LL50, NOELR, LOELR and LL100 were determined directly from the raw data. - Sublethal observations / clinical signs:
VALIDITY CRITERIA
The validity criteria were within the acceptable limits (Table 1). Therefore, the study is valid.
Table 1: Validity criteria for OECD 203.
Guideline criterion
Outcome
Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test
Mortality in the control after 96 h: 0%
Yes
The dissolved oxygen concentration must have been at least 60 per cent of the air
saturation value throughout the test
Dissolved oxygen concentrations were 94 – 98% of the air saturation value during the test.
Yes
There must be evidence that the concentration of the substance being tested has been
satisfactorily maintained, and preferably it should be at least 80 per cent of the
nominal concentration throughout the test. If the deviation from the nominal
concentration is greater than 20 per cent, results should be based on the measured
concentration.
According to the obtained results of the validation, the test item has very low solubility in water below the Limit of Quantification. Therefore, the test item concentrations could not be determined.
not applicable
BIOLOGICAL RESULTS
The cumulative mortality during the definitive test is given in Table 2.
Table 2. Mortality data.
test group
mortality rate of treated fish (dead fish/treated fish)
3 h
6 h
24 h
48 h
72 h
96 h
control
0/7
0/7
0/7
0/7
0/7
0/7
100 mg/L
0/7
0/7
0/7
0/7
0/7
0/7
CONCLUSION
Based on the result, the test item had no toxic effect on fish at aquatic saturation. The LL50 values and the LOELR are higher than the solubility level of the test item in the test medium.
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Reference
Description of key information
No effects up to the limit of water solubility (OECD 203, O. mykiss)
Key value for chemical safety assessment
Additional information
There is one experimental study available, in which the toxicity of Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5) to fish was investigated according to OECD guideline 203 and in compliance with GLP.
In a static limit test, the Rainbow trout Oncorhynchus mykiss was exposed to a 100% v/v saturated solution for 96 h. Since the test item is very poorly soluble in water, a supersaturated test item solution was prepared by dispersing a nominal concentration of 100 mg/L test item in test medium 2 d prior test start, shaking for 24 h (at approximately 30 °C) and finally filtering the solution through a 0.22 µm filter prior use. A chemical analysis of test item concentrations in the test solution was not possible due to the very low solubility of the test item in water (below the limit of quantification).
After 96 h, no mortality was observed. Based on the obtained results, Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5) had no toxic effect on fish at aquatic saturation and the derived LL50 (96 h) was > 100 mg/L (above the solubility level of the test item in the test medium).
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