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EC number: 219-350-2 | CAS number: 2422-88-0
- 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 aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Jul 2017 - 21 Aug 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 22 March 2017 to 01 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- flask method
- Key result
- Water solubility:
- 0.016 g/L
- Incubation duration:
- >= 24 - <= 168 h
- Temp.:
- 20 °C
- pH:
- >= 6.3 - <= 7
- Details on results:
- The 72-hour measurement was significantly higher than the 24- and 48- hour measurements (maximum difference > 15%). In order to rule out any erroneous sample preparation of the deviating sample from the 72-h-stirred vessel, this sample was reanalysed in duplicate. Obtained results, however, were comparable to what was obtained during initial analysis.
As observed concentrations increased with stirring time, stirring was prolonged. The 168-hour measurement was, again, significantly higher than the 120- and 144- hour measurements (maximum difference > 15%). Obviously the higher result of the third vessel was linked to the specific water solubility vessel. No observations had been made which could explain the difference in observed concentrations. 120-, 144- and 168-hour measurements illustrated, however, that the equilibrium concentration was already reached. The coefficient of variation obtained for the different water solubility concentrations was 22%. As this approximated what was considered acceptably repeatable during validation, the water solubility of the test item was calculated as the mean value of all measurements. - Conclusions:
- The water solubility of the substance at 20°C was determined to be 0.016 g/L.
- Executive summary:
The water solubility of the substance was determined using the flask method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840. Quantification was performed by LC-MS-MS. As observed concentrations increased with stirring time, stirring was prolonged to 168 h. Maximum difference between all results: 58%. The coefficient of variation obtained for the different water solubility concentrations was 22%. As this approximated what was considered acceptably repeatable during validation, the water solubility of the test item was calculated as the mean value of all measurements (24, 48, 72, 120, 144 and 168 hours). The water solubility at 20°C was determined to be 0.016 g/L. The pH of the aqueous samples ranged from 6.3 to 7.0.
Results of the flask method
Stirring time |
Analyzed concentration |
Mean |
Maximum difference |
pH |
24 |
0.0136 |
|
|
7.0 |
48 |
0.0149 |
|
|
7.0 |
72 |
0.0210 |
|
|
6.9 |
72 |
0.0196 |
|
|
- |
72 |
0.0187 |
|
|
- |
120 |
0.0116 |
|
|
6.5 |
144 |
0.0123 |
|
|
6.4 |
168 |
0.0173 |
|
|
6.3 |
|
|
0.016 |
58 |
|
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tributyl-2-thiourea
- EC Number:
- 219-350-2
- EC Name:
- Tributyl-2-thiourea
- Cas Number:
- 2422-88-0
- Molecular formula:
- C13H28N2S
- IUPAC Name:
- 1,1,3-tributylthiourea
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Tri butyl thiourea
- Appearance: Clear pale to medium brown liquid
- Storage conditions: At room temperature
Constituent 1
- Specific details on test material used for the study:
- Solubility in water: please refer to section 4.8 of this dossier.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control, 1.0, 2.2, 4.6, 10, 22, 46, 100% of Saturated Solution
- Sampling method: 2.0 mL from the approximate centre of the test vessels, at t=0h and t=48h.
- Sample storage conditions before analysis: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
- At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with a loading rate of 100 mg/L applying a one-day period of magnetic stirring in a closed vessel to ensure maximum dissolution of the test item in medium. The obtained aqueous mixture was allowed to settle for a period of two hours in the combined limit/range-finding test and two hours and a half in the full test. Thereafter, the Saturated Solution (SS) was collected by means of siphoning and used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- Controls: Test medium without test item or other additives
- All test solutions were clear and colorless at the end of the preparation procedure.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: Daphnia magna Straus 1820
- Source: In-house laboratory culture with a known history.
- Age of parental stock: >2 weeks
- Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
- Feeding during test: no
- Age of test organisms at start of test: <24 h
BREEDING
- Start of each batch: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel.
- Maximum age of the cultures: 4 weeks
- Renewal of the cultures: After 7 days of cultivation half of the medium twice a week.
- Temperature of medium: 18-22°C
- Feeding: Daily, a suspension of fresh water algae.
- Medium: M7 medium
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L expressed as CaCO3
- Test temperature:
- 20°C
- pH:
- start: 7.9
end: 7.9-8.0 - Dissolved oxygen:
- start: 8.9-9.1
end: 8.9-9.0 - Nominal and measured concentrations:
- Nominal: 0, 1.0, 2.2, 4.6, 10, 22, 46, 100 % of Saturated Solution
Measured at start: n.d., 0.198, 0.442, 0.985, 2.05, 4.64, 10.2, 22.4 mg/L
Measured at end: n.d., 0.209, 0.472, 0.983, 2.06, 4.58, 10.1, 21.6 mg/L
The measured concentrations remained stable throughout the test duration, i.e. were 97-107% of initially measured at the end of the test. Given these results, the EC50 was calculated using the measured initial concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 60 mL all-glass, containing 50 mL test solution
- Aeration: no aeration
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Feeding: no feeding during test.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium, made with Reverse Osmosis water with the following chemicals dissolved: CaCl2.2H2O (211.5 mg/L), MgSO4.7H2O (88.8 mg/L), NaHCO3 (46.7 mg/L) and KCl (4.2 mg/L).
- Culture medium different from test medium: yes (M7 medium used as culture medium)
- Intervals of water quality measurement: Dissolved oxygen: At the beginning and at the end of the test, for all concentrations and the control. In addition, after 24 hours, immediately after counting the immobilized daphnids, oxygen levels were measured in one replicate of the undiluted SS because all the Daphnia magna were immobilized. Temperature of medium: Continuously in a temperature control vessel, beginning at the start of the test.
OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily.
EFFECT PARAMETERS MEASURED:
- Immobility (including mortality), at 24 h and at 48 h.
RANGE-FINDING STUDY
- Test concentrations: control (0%), 1.0, 10, 100% of Saturated Solution prepared at 100 mg/L.
- Results used to determine the conditions for the definitive study: Yes. - Reference substance (positive control):
- yes
- Remarks:
- Potassium Dichromate (performed June 2017)
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Details on results:
- - After 24 hours of exposure, 100% effect was observed in the highest concentration, while no biologically significant immobility was recorded at any of the lower concentrations tested and in the control. After 48 hours of exposure, a dose-response relationship was observed.
- Behavioural abnormalities: None observed.
- Mortality of control: None observed.
- Other adverse effects control: No signs of disease or stress, for example discoloration or unusual behaviour such as trapping at the surface of the medium. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes. The actual responses in this reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations, i.e. the 48h-EC50 was between 0.3 and 1.0 mg/L. Hence, the sensitivity of this batch of D. magna was in agreement with the historical data collected at the Test Facility.
- Relevant effect levels:
24h-EC50: 0.95 mg/L with a 95% confidence interval between 0.85 and 1.1 mg/L.
48h-EC50: 0.59 mg/L with a 95% confidence interval between 0.52 and 0.66 mg/L. - Reported statistics and error estimates:
- The 24 and 48h-EC50-values were calculated using the Spearman-Karber method (without trim) on the percentages of affected daphnids and the logarithms of the corresponding test item concentrations (measured initial).
ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analyses.
Any other information on results incl. tables
Number of Introduced Daphnids and Incidence of Immobility in the Final Test
Time (h) |
Replicate |
Tri butyl thiourea; measured initial concentrations (mg/L) |
|||||||
Control |
0.20 |
0.44 |
0.98 |
2.0 |
4.6 |
10 |
22 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
D |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Total introduced |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
|
|
|
||||||||
24 |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5# |
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
|
C |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
5 |
|
D |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
5 |
|
Total immobilised |
0 |
0 |
0 |
2 |
1 |
0 |
1 |
20 |
|
Effect % |
0 |
0 |
0 |
10 |
5 |
0 |
5 |
100 |
|
|
|
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
1 |
1 |
2 |
5 |
5 |
B |
0 |
0 |
0 |
0 |
2 |
2 |
5 |
5 |
|
C |
0 |
0 |
0 |
3 |
1 |
2 |
5 |
5 |
|
D |
0 |
0 |
0 |
1 |
3 |
3 |
5 |
5 |
|
Total immobilised |
0 |
0 |
0 |
5 |
7 |
9 |
20 |
20 |
|
Effect % |
0 |
0 |
0 |
25 |
35 |
45 |
100 |
100 |
#Microscopic observation revealed no test item stuck to the daphnids.
Analysis of Test Samples (Final Test)
Time of sampling |
Date of sampling |
Date of |
Percentage of SS2 |
Analyzed concentration |
Relative to |
0 |
07 Aug 2017 |
21 Aug 2017 |
0 |
n.d. |
|
|
|
|
1.0 |
0.198 |
|
|
|
|
2.2 |
0.442 |
|
|
|
|
4.6 |
0.985 |
|
|
|
|
10 |
2.05 |
|
|
|
|
22 |
4.64 |
|
|
|
|
46 |
10.2 |
|
|
|
|
100 |
22.4 |
|
48 |
09 Aug 2017 |
21 Aug 2017 |
0 |
n.d. |
n.a. |
|
|
|
1.0 |
0.209 |
105 |
|
|
|
2.2 |
0.472 |
107 |
|
|
|
4.6 |
0.983 |
100 |
|
|
|
10 |
2.06 |
101 |
|
|
|
22 |
4.58 |
99 |
|
|
|
46 |
10.1 |
99 |
|
|
|
100 |
21.6 |
97 |
1 Samples were stored in the freezer (≤ -15°C) until the day of analysis.
2 Percentage of a saturated solution (SS) prepared at a loading rate of 100 mg/L.
n.d. Not detected.
n.a.Not applicable.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For details on validity criteria see 'Overall remarks' section.
- Conclusions:
- In conclusion, the 48h-EC50 for Daphnia magna exposed to Tri butyl thiourea was 3.0 mg/L based on measured initial concentrations (95% confidence interval between 2.2 and 4.0 mg/L).
- Executive summary:
In a 48 h acute toxicity test conducted according to OECD guideline 202, Daphnia magna were exposed to Tri butyl thiourea at nominal concentrations of 0, 1.0, 2.2, 4.6, 10, 22, 46, and 100% of a Saturated Solution prepared at 100 mg/L (measured initial concentrations: n.d., 0.20, 0.44, 0.98, 2.0, 4.6, 10, 22 mg/L). A dose-response relationship for immobility was observed at 48 h. The 48h-EC50 for Daphnia magna exposed to Tri butyl thiourea was 3.0 mg/L based on measured initial concentrations. The study is considered to be reliable without restrictions.
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