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EC number: 266-037-1 | CAS number: 65997-01-5
- 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
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2009-04-24 to 2009-04-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100 mg/L
- Vehicle:
- no
- Test organisms (species):
- activated sludge
- Details on inoculum:
- - Pretreatment: The activated sludge was washed three times with tap water and filtered using paper filter.
- Initial biomass concentration: The recommended amount of wet sludge for test vessels was calculated to obtain a suspended solids level of 4 g/L (±10%) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
- Test temperature:
- 19.9 - 20.9 °C
- Dissolved oxygen:
- The preparations (control 1, 1 test loading rate of the test item, reference item in 3 test concentrations, control 2) were made up in 15 minute intervals and were aerated continuously so that a dissolved oxygen level of ≥ 6.5 mg/L was achieved during the whole test duration.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Control 1, 1 test loading rate of test item, reference item in 3 test concentrations, control 2.
- Type (delete if not applicable): open
- Aeration: Continuous, membrane pump
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2
- Biomass loading rate: 100 mg/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Deionised water
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 100 mg/L
- Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dichlorophenol
- Key result
- Duration:
- 3 h
- Dose descriptor:
- other: EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks on result:
- other: 95% CL, Significant level 0.05
- Results with reference substance (positive control):
- - Results with reference substance valid? Yes: Deviation between respiration rates of the controls, 14.5%
- Relevant effect levels: EC50 (3 h): 12.2 mg/L, NOEC < 5.0 mg/L - Reported statistics and error estimates:
- Determination of the EC50 of the reference item 3,5-dichlorophenol was accomplished using Probit-analysis (Finney-method, lognormal distribution, confidence limit 95%, significance level: 0.05).
- Validity criteria fulfilled:
- yes
- Conclusions:
- A Water Accommodated Fractions (WAFs) value EL50 of > 100 mg/L and a NOELR of 100 mg/L have been determined for CTO in a test conducted according to OECD 209. The result is considered reliable.
- Endpoint:
- activated sludge respiration inhibition testing
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2009-04-24 to 2009-04-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Different laoding rates (5 - 100 mg/l)
- Vehicle:
- no
- Test organisms (species):
- activated sludge
- Details on inoculum:
- - Laboratory culture:
- Pretreatment: The activated sludge was washed three times with tap water and filtered using paper filter
- Initial biomass concentration: The recommended amount of wet sludge for test vessels was calculated to obtain a suspended solids level of 4 g/L (±10%) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
- Test temperature:
- 19.9 - 20.9 °C
- Dissolved oxygen:
- The preparations (control 1, 1 test loading rate of the test item, reference item in 3 test concentrations, control 2) were made up in 15 minute intervals and were aerated continuously so that a dissolved oxygen level of ≥ 6.5 mg/L was achieved during the whole test duration.
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Aeration: continuous, membrane pump
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2
- Biomass loading rate: 100 mg/l
- Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dichlorophenol
- Key result
- Duration:
- 3 h
- Dose descriptor:
- other: EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks on result:
- other: 95% CL, Significant level 0.05
- Results with reference substance (positive control):
- - Results with reference substance valid? Yes: Deviation between respiration rates of the controls, 14.5%
- Relevant effect levels: Yes: Deviation between respiration rates of the controls, 14.5% - Reported statistics and error estimates:
- Determination of the EC50 of the reference item 3,5-dichlorophenol was accomplished using Probit-analysis (Finney-method, lognormal distribution, confidence limit 95%, significance level: 0.05).
- Validity criteria fulfilled:
- yes
- Conclusions:
- A Water Accommodated Fractions (WAFs) value EL50 of > 100 mg/L and a NOELR of 100 mg/L have been determined for CTO in a test conducted according to OECD 209. The result is considered reliable.
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Guideline study without GLP. The test report is lacking in experimental detail but the test was conducted in accordance with a recognised guideline.
- Qualifier:
- according to guideline
- Guideline:
- other: ISO standard 11348-3:1998(E)
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test media were prepared by dilution of a stock solution that had been prepared by 27.1x dilution of the substance. - Test organisms (species):
- Vibrio fisheri
- Details on inoculum:
- No data
- Test type:
- static
- Water media type:
- saltwater
- Limit test:
- no
- Total exposure duration:
- 5 min
- Hardness:
- No data
- Test temperature:
- No data
- pH:
- The pH of all samples was adjusted to 7 at the start of the test in order to avoid pH effects.
- Dissolved oxygen:
- No data
- Salinity:
- No data
- Nominal and measured concentrations:
- No data
- Details on test conditions:
- Method
- The bacteria were exposed to samples at various concentrations for 5-15 min, after which the ability of the bacteria to generate light (bioluminescence) was measured. The toxicity was calculated from the reduction in bioluminescence. The pH of all samples was adjusted to 7 in order to avoid pH effects. - Reference substance (positive control):
- no
- Duration:
- 15 min
- Dose descriptor:
- EC50
- Effect conc.:
- 0.01 other: vol. %
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: inhibition of bioluminescence
- Duration:
- 15 min
- Dose descriptor:
- EC50
- Effect conc.:
- 103 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- assuming density of sample is 1030 mg/ml
- Basis for effect:
- other: inhibtiion of bioluminescence
- Details on results:
- No data
- Reported statistics and error estimates:
- No data
- Validity criteria fulfilled:
- yes
- Conclusions:
- A 15-minute EC50 of 103 mg/L (0.01 vol. %) has been determined for the effects of the test substance on inhibition of bioluminescence in Vibrio fisheri
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Guideline study without GLP. The test report is lacking in experimental detail but the test was conducted in accordance with a recognised guideline.
- Qualifier:
- according to guideline
- Guideline:
- other: ISO standard 11348-3:1998(E)
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test media were prepared by dilution of a stock solution that had been prepared by 28.5x dilution of the substance. - Test organisms (species):
- Vibrio fisheri
- Details on inoculum:
- No data
- Test type:
- static
- Water media type:
- saltwater
- Limit test:
- no
- Total exposure duration:
- 5 min
- Hardness:
- No data
- Test temperature:
- No data
- pH:
- The pH of all samples was adjusted to 7 at the start of the test in order to avoid pH effects.
- Dissolved oxygen:
- No data
- Salinity:
- No data
- Nominal and measured concentrations:
- No data
- Details on test conditions:
- Method
- The bacteria were exposed to samples at various concentrations for 5-15 min, after which the ability of the bacteria to generate light (bioluminescence) was measured. The toxicity was calculated from the reduction in bioluminescence. The pH of all samples was adjusted to 7 in order to avoid pH effects. - Reference substance (positive control):
- no
- Duration:
- 15 min
- Dose descriptor:
- EC50
- Effect conc.:
- 0.01 other: vol. %
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: inhibition of bioluminescence
- Duration:
- 15 min
- Dose descriptor:
- EC50
- Effect conc.:
- 103 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- assuming density of sample is 1030 mg/ml
- Basis for effect:
- other: inhibition of bioluminescence
- Details on results:
- No data
- Reported statistics and error estimates:
- No data
- Validity criteria fulfilled:
- yes
- Conclusions:
- A 15-minute EC50 of 100 mg/L (0.01 vol. %) has been determined for the effects of the test substance on inhibition of bioluminescence in Vibrio fisheri
Referenceopen allclose all
Table2:Results of the Activated Sludge, Respiration Inhibition Test of CTO Sample 5
|
c / Loading rate (mg/L) |
Respiration rate (mg O2/L x h)
|
Inhibition (%) |
Control 1 |
- |
53.3 |
- |
Reference |
3 |
47.1 |
18.6 |
10 |
36.4 |
37.1 |
|
30 |
12.8 |
77.9 |
|
Test item |
100 |
70.6 |
-22.1* |
Control 2 |
- |
62.3 |
- |
Remark: * The negative inhibition value indicates, that the respiration rate was higher compared to the control.
Table2:Results of the Activated Sludge, Respiration Inhibition Test of CTO Sample 3
|
c / Loading rate (mg/L) |
Respiration rate (mg O2/L x h)
|
Inhibition (%) |
Control 1 |
- |
53.3 |
- |
Reference |
3 |
47.1 |
18.6 |
10 |
36.4 |
37.1 |
|
30 |
12.8 |
77.9 |
|
Test item |
5 |
55.8 |
3.5 |
|
10 |
64.9 |
-12.2* |
|
25 |
75.0 |
-29.7* |
|
50 |
69.6 |
-20.3* |
|
100 |
70.6 |
-22.1* |
Control 2 |
- |
62.3 |
- |
Remark: * * Negative inhibition values indicate, that respiration rates were higher compared to the control. Taking into account the variation of results in the control and at the test loading rates of CTO Sample 3 the result of inhibition of 3.5 % at test loading rate of 5 mg/L is not regarded as a definite inhibition.
Description of key information
Activated sludge respiratory inhibition (ASRI) test results have been read across from Crude Tall Oil (CTO) to TOS.
Water Accommodated Fractions (WAFs) of two CTO samples caused no acute toxic effects on bacteria in an Activated Sludge, Respiration Inhibition (ASRI) test conducted as a limit test according to OECD 209. A 3 hour EL50 of > 100 mg/L and a NOELR of 100 mg/L have been determined for the test substance.
In addition, data are available for the substance itself from a study conducted in accordance with a recognised test guideline. An EC50 of 103 mg/L (0.01% volume) was obtained for the effects of TOS on inhibition of bioluminescence in Vibrio fischeri. Vibrio fischeri is a bacterium found globally in marine environments. This study is selected as supporting study as the data are less relevant to waste water treatment systems.
Read-across justification:
The use of ecotoxicity data for the read-across substance Crude Tall Oil (CTO; temporary list number 931-433-1) is justified on the following basis.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
A read across from Crude Tall Oil to TOS can be justified on the following basis.
Crude Tall Oil (CTO), list number 931-433-1, is the term applied to the processed mixture of naturally occurring compounds extracted from tree species like pine, spruce, birch and aspen. CTO is formed by the acidification of TOS, therefore, CTO and TOS are similar substances. They differ only in the water content and that CTO does not contain sodium salts of the fatty/rosin acids.
The main constituents of TOS are sodium salts of saturated and unsaturated C14-20 fatty acids (5-45% w/w), rosin acid sodium salts (10-40% w/w), water (25-45% w/w), sterols (1-10% w/w), and non-volatile lignin/cellulose fibre/oligomeric acids (3-20% w/w). In addition, the following minor constituent blocks are present: terpenes, sesquiterpenes, abietenes and labdanes, C30 branched polyakenes, 3,5 -dimethoxystilbene, rosin alcohol and aldehyde isomers and saturated/unsaturated alcohols and terpene alcohols (each <3% w/w).
The same constituents are present in CTO, with only the following differences:
-The fatty acids and rosin acids in TOS are present as their sodium salts whereas for CTO they are present as acids. In aqueous media, the sodium salts are dissociated into sodium and the parent acid. The sodium, being a ubiquitous and essential element in nature, is not expected to contribute to the toxicity properties of the substance.
-TOS contains 25-45% water compared to trace amounts in CTO; other constituent groups are therefore present at lower levels in TOS but in similar proportions to CTO.
The hypothesis for the read-across approach is that in the environment and under standard laboratory test conditions organisms would be exposed to essentially the same constituents (and in similar proportions) whether they originate from TOS or CTO and so the ecotoxicity of TOS would be substantially the same as that for CTO.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Both CTO and TOS are UVCB substances that contain fatty acids, rosin acids, neutrals such alcohols, sterols, aldehydes etc. For UVCB substances, impurities are not considered relevant for substance identification. The fatty and rosin acids present in TOS are in the form of the sodium salt. In the environment, the sodium salts of fatty and rosin acids will dissociate and speciate in a similar way to each other. The sodium salts in TOS will ionise into sodium ions and a mixture of the acid anion/parent acid (depending on the pH) and CTO will dissociate into the same mixture of the acid anion/parent acid (again depending on the pH). Sodium is a ubiquitous, essential element in nature and will not contribute to the toxicity of the acid and as such it is considered relevant to read-across the available data for CTO to TOS.
Therefore, it can be concluded that in the environment and under standard laboratory test conditions, the organisms would be exposed to essentially the same constituents and (and in similar proportions) whether they originate from TOS or CTO and so the read-across of ecotoxicity data from CTO to TOS is justified.
Key value for chemical safety assessment
Additional information
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.