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EC number: 245-740-7 | CAS number: 23564-05-8
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-07-24 to 1989-08-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- October 2012
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.18, 0.56, 1.8, 5.6 and 18.0 mg/L
- Sampling method: samples of fresh media were taken on Day 0 and expired media were taken on Days 2, 4, 7, 9, 11, 14, 16, 18 and 21 from each test and solvent control vessel (replicates pooled). Test item concentration in the samples was determined by high performance liquid chromatography, using an external standard technique. - Vehicle:
- yes
- Remarks:
- 1 % Tween 80 in dimethylformamide
- Details on test solutions:
- Standard stock solutions were prepared in 1 % Tween 80 in dimethyl-formamide at concentrations of approximately 1.8, 5.6, 18.0, 56.0 and 180 g/L. These stock solution were then further diluted with dechlorinated tap water, to give approximate Thiophanate methyl concentrations of 0.18, 0.56, 1.8, 5.6 and 18.0 mg/L, respectively. The stability of the test concentrations were verified by chemical analysis.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Straus
- Age at study initiation: Young daphnids produced overnight were used for testing
- Source: Institute National de Recherche Chimique Appliquée (I.R.CH.A.)
- Feeding during test: yes
- Food type: unicellular algal and fry fish food
ACCLIMATION
At 20 ± 2 °C in glass vessels containing two litres of dechlorinated and aged tap water. Cultures were fed daily with a mixture of fry fish food (Liquifry) and a suspension of mixed algae (predominantly Chlorella spp.). Culture conditions ensure that reproduction is by parthenogenesis. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 50 mg/L as CaCO3
- Test temperature:
- 21 ± 1 °C
- pH:
- 7.7 - 7.8
- Dissolved oxygen:
- 8.0 to 8.8 mg/L
- Nominal and measured concentrations:
- Nominal concentration: 0.18, 0.56, 1.8, 5.6 and 18 mg/L
Concentration found initially: 0.168, 0486, 1.65, 5.24 and 16.3 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass flasks
- Material and fill volume: Glass flasks each containing 400 mL test solution.
- Aeration: none
- Renewal rate of test solution: 3 times per week
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per solvent control (replicates): 4
- Biomass loading rate: 40 mL test solution per organism
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated (with sodium thiosulphate) and aged laboratory tap water
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light: 8h dark
EFFECT PARAMETERS MEASURED: Immobilisation and reproduction - Reference substance (positive control):
- not specified
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.161 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Results of the re-evaluation of the study using ToxRat (version 3.2.1)
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 0.273 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Results of the re-evaluation of the study using ToxRat (version 3.2.1)
- Duration:
- 21 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 0.215 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Results of the re-evaluation of the study using ToxRat (version 3.2.1)
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.19 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Results of the re-evaluation of the study using ToxRat (version 3.2.1)
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.64 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: Results of the re-evaluation of the study using ToxRat (version 3.2.1)
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 2.77 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: Results of the re-evaluation of the study using ToxRat (version 3.2.1)
- Duration:
- 21 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 1.96 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: Results of the re-evaluation of the study using ToxRat (version 3.2.1)
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 1.63 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: Results of the re-evaluation of the study using ToxRat (version 3.2.1)
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.18 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Results based on initial Daphnia magna toxicity study with Thiophanate-methyl (Handley, 1990, RD-9010) conducted according to the OECD 202 Part II guideline
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Results based on initial Daphnia magna toxicity study with Thiophanate-methyl (Handley, 1990, RD-9010) conducted according to the OECD 202 Part II guideline
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 3.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: Results based on initial Daphnia magna toxicity study with Thiophanate-methyl (Handley, 1990, RD-9010) conducted according to the OECD 202 Part II guideline
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.18 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: Results based on initial Daphnia magna toxicity study with Thiophanate-methyl (Handley, 1990, RD-9010) conducted according to the OECD 202 Part II guideline
- Details on results:
- In preparation of the renewal of Thiophanate-methyl according to Annex I of Regulation (EC) No 1107/2009, the validity of the available Daphnia magna toxicity study with Thiophanate-methyl (Handley, 1990, RD-9010) was checked. The study was re-evaluated with the statistic programme ToxRat® Professional (version 3.2.1) in order to see whether the study is still valid and complies with requirements of the current OECD 211 guideline. The nominal test item concentrations were 0.18, 0.56, 1.8, 5.6, and 18 mg/L. All test item treatment groups were analysed. As the measured concentrations differed to more than 20 % from the nominal concentrations, the reported biological results are related to the geometric mean measured concentrations of the test item (0.161, 0.476, 1.64, 5.22, and 16.2 mg/L).
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EC10, EC20 and EC50 values for the endpoint immobility were 1.63, 1.96 and 2.77 mg/L, respectively. For the endpoint reproduction, the EC10, EC20 and EC50 values were 0.190, 0.215 and 0.273 mg/L, respectively. The NOEC values for immobility and reproduction were 1.64 and 0.161 mg/L, respectively.
- Executive summary:
In preparation of the renewal of Thiophanate-methyl according to Annex I of Regulation (EC) No 1107/2009, the validity of the available Daphnia magna toxicity study with Thiophanate-methyl (Handley, 1990, RD-9010) was checked. The study was conducted according to the OECD 202 Part II guideline. In the study report, the following endpoints were obtained (relative to the performance of the control):
Immobility: Based on nominal concentrations, the 21-day EC50 value for immobility was calculated as 3.1 mg/L. Based on the statistical evaluation, the 21-day No-Observed-Effect Concentration (NOEC) was equal to 0.18 mg/L.
Reproduction: Based on nominal concentrations, the 21-day EC50 value for reproduction was calculated as 3.2 mg/L. Based on the statistical evaluation, the 21-day No-Observed-Effect Concentration (NOEC) was equal to 0.18 mg/L.
The study was re-evaluated with the statistic programme ToxRat® Professional (version 3.2.1) in order to see whether the study is still valid and complies with requirements of the current OECD 211 guideline. The present report provides the re-calculated endpoints as well as the detailed data of the statistical evaluation. The study is considered valid as the following validity criteria were met:
1) the maximum control mortality in females must not exceed 20 % (actual 0 %), and
2) the mean offspring number at day 21 must be at least 60.0 (actual 75.1).
With respect to these criteria, the test is valid.
The nominal test item concentrations were 0.18, 0.56, 1.8, 5.6, and 18 mg/L. All test item treatment groups were analysed. As the measured concentrations differed to more than 20 % from the nominal concentrations, the reported biological results are related to the geometric mean measured concentrations of the test item (0.161, 0.476, 1.64, 5.22, and 16.2 mg/L).
The EC10, EC20 and EC50 values for the endpoint immobility were 1.63, 1.96 and 2.77 mg/L, respectively. For the endpoint reproduction, the EC10, EC20 and EC50 values were 0.190, 0.215 and 0.273 mg/L, respectively. The NOEC values for immobility and reproduction were 1.64 and 0.161 mg/L, respectively.
Reference
Table 1: Toxicity endpoints for effects on immobility and reproduction of the Daphnia magna study (Handley, 1990) after exposure to Thiophanate-methyl
Parameter | EC10 [mg/L] | EC20 [mg/L] | EC50 [mg/L] | NOEC [mg/L] |
0 - 21 d immobility (95 % confidence intervals) | 1.63 (1.36 - 1.89) | 1.96 (1.67 - 2.24) | 2.77 (2.43 - 3.17) | 1.64 |
0 - 21 d reproduction (95 % confidence intervals) | 0.190 (0.181 - 0.199) | 0.215 (0.205 - 0.225) | 0.273 (0.261 - 0.285) | 0.161 |
Table 2: Analytical resuts
Nominal test concentration | Mean measured concentration | % of nominal values |
Control | - | - |
0.18 | 0.168 | 93.3 |
0.56 | 0.486 | 86.8 |
1.8 | 1.65 | 91.7 |
5.6 | 5.24 | 93.5 |
18 | 16.3 | 90.6 |
Table 3: Summary of Results for all Endpoints at the End of Exposure Period: Critical effect and threshold concentration as observed at end of experimental time; EC: Effective concentration for xx % reduction; 95 %-CL: 95 % Confidence limits; LOEC: Lowest observed effect concentration; NOEC: No observed effect concentration.
Critical Conc. [mg/L] | ||
Cumulative offspring per introduced parent (21.0 d) | ||
95 % - CL | EC10 | 0.190 |
Lower | 0.181 | |
upper | 0.199 | |
95 % - CL | EC20 | 0.215 |
Lower | 0.205 | |
Upper | 0.225 | |
95 % - CL | EC50 | 0.273 |
lower | 0.261 | |
upper | 0.285 | |
Cumulative offspring per introduced parent LOEC | 0.476 | |
NOEC | 0.161 | |
Cumulative offspring per survived parent (0 - 21.0 d) | ||
95 % - CL | EC10 | 0.190 |
Lower | 0.181 | |
upper | 0.199 | |
95 % - CL | EC20 | 0.215 |
Lower | 0.205 | |
Upper | 0.225 | |
95 % - CL | EC50 | 0.273 |
lower | 0.261 | |
upper | 0.285 | |
Cumulative offspring per introduced parent LOEC | 0.476 | |
NOEC | 0.161 | |
Immobility (0 - 21.0 d) | ||
95 % - CL | EC10 | 1.633 |
Lower | 1.356 | |
upper | 1.893 | |
95 % - CL | EC20 | 1.958 |
Lower | 1.668 | |
Upper | 2.241 | |
95 % - CL | EC50 | 2.770 |
lower | 2.427 | |
upper | 3.165 | |
Immobility | LOEC | 5.220 |
NOEC | 1.640 |
Table 4: Offspring per Day and Parent as Dependent on Concentration and Time (Offspring per day and parent in Daphnia magna as dependent on concentration of the test item and time; Mean: arithmetic mean; Std.Dev.: standard deviation; n: number of replicates; CV: coefficient of variation (from Input Offspring))
Treatm. [mg/L] | Control | Solvent | 0.161 | 0.476 | 1.640 | 5.220 | 16.200 | |
0.0 d | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
Mean: | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
Std.Dev.: | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | |
n: | 4 | 4 | 4 | 4 | 4 | 4 | 4 | |
CV: |
|
|
|
|
|
|
| |
21.0 d | 773.0 | 733.0 | 743.0 | 19.0 | 0.0 | 0.0 | 0.0 | |
| 731.0 | 801.0 | 754.0 | 18.0 | 0.0 | 0.0 | 0.0 | |
| 770.0 | 776.0 | 720.0 | 20.0 | 0.0 | 0.0 | 0.0 | |
| 731.0 | 689.0 | 699.0 | 16.0 | 0.0 | 0.0 | 0.0 | |
Mean: | 751.3 | 749.8 | 729.0 | 18.3 | 0.0 | 0.0 | 0.0 | |
Std.Dev.: | 23.41 | 49.28 | 24.51 | 1.71 | 0.00 | 0.00 | 0.00 | |
n: | 4 | 4 | 4 | 4 | 4 | 4 | 4 | |
CV: | 3.1 | 6.6 | 3.4 | 9.4 |
|
|
|
Table 5: Offspring per Day and Beaker as Dependent on Concentration and Time (Offspring per day and beaker in Daphnia magna as dependent on concentration of the test item and time; Mean: arithmetic mean; Std.Dev.: standard deviation; n: number of replicates; CV: coefficient of variation (from Input Offspring))
Treatm. [mg/L] | Control | Solvent | 0.161 | 0.476 | 1.640 | 5.220 | 16.200 | ||
0.0 d | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
Mean: | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
Std.Dev.: | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | ||
n: | 4 | 4 | 4 | 4 | 4 | 4 | 4 | ||
CV: |
|
|
|
|
|
|
| ||
21.0 d | 77.3 | 73.3 | 74.3 | 1.9 | 0.0 | 0.0 | 0.0 | ||
| 73.1 | 80.1 | 75.4 | 1.8 | 0.0 | 0.0 | 0.0 | ||
| 77.0 | 77.6 | 72.0 | 2.0 | 0.0 | 0.0 | 0.0 | ||
| 73.1 | 68.9 | 69.9 | 1.6 | 0.0 | 0.0 | 0.0 | ||
Mean: | 75.1 | 75.0 | 72.9 | 1.8 | 0.0 | 0.0 | 0.0 | ||
Std.Dev.: | 2.34 | 4.93 | 2.45 | 0.17 | 0.00 | 0.00 | 0.00 | ||
n: | 4 | 4 | 4 | 4 | 4 | 4 | 4 | ||
CV: | 3.1 | 6.6 | 3.4 | 9.4 |
|
|
|
Cumulative Offspring per Introduced Parent (Data)
Table 6: Cumulative Offspring per Introduced Parent as Dependent on Concentration and Time (Cumulative offspring per introduced parent in Daphnia magna as dependent on concentration of the test item and time; Mean: arithmetic mean; Std.Dev.: standard deviation; n: number of replicates; CV: coefficient of variation (calculated from Input Offspring))
Treatm. [mg/L] | Control | Solvent | 0.161 | 0.476 | 1.640 | 5.220 | 16.200 |
21.0 d | 77.3 | 73.3 | 74.3 | 1.9 | 0.0 | 0.0 | 0.0 |
| 73.1 | 80.1 | 75.4 | 1.8 | 0.0 | 0.0 | 0.0 |
| 77.0 | 77.6 | 72.0 | 2.0 | 0.0 | 0.0 | 0.0 |
| 73.1 | 68.9 | 69.9 | 1.6 | 0.0 | 0.0 | 0.0 |
Mean: | 75.1 | 75.0 | 72.9 | 1.8 | 0.0 | 0.0 | 0.0 |
Std.Dev.: | 2.34 | 4.93 | 2.45 | 0.17 | 0.00 | 0.00 | 0.00 |
n: | 4 | 4 | 4 | 4 | 4 | 4 | 4 |
CV: | 3.1 | 6.6 | 3.4 | 9.4 |
|
|
|
Description of key information
The EC10, EC20 and EC50 values for the endpoint immobility were 1.63, 1.96 and 2.77 mg/L, respectively. For the endpoint reproduction, the EC10, EC20 and EC50 values were 0.190, 0.215 and 0.273 mg/L, respectively. The NOEC values for immobility and reproduction were 1.64 and 0.161 mg/L, respectively.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.161 mg/L
Additional information
In preparation of the renewal of Thiophanate-methyl according to Annex I of Regulation (EC) No 1107/2009, the validity of the available Daphnia magna toxicity study with Thiophanate-methyl (Handley, 1990, RD-9010) was checked. The study was conducted according to the OECD 202 Part II guideline. In the study report, the following endpoints were obtained (relative to the performance of the control):
Immobility: Based on nominal concentrations, the 21-day EC50 value for immobility was calculated as 3.1 mg/L. Based on the statistical evaluation, the 21-day No-Observed-Effect Concentration (NOEC) was equal to 0.18 mg/L.
Reproduction: Based on nominal concentrations, the 21-day EC50 value for reproduction was calculated as 3.2 mg/L. Based on the statistical evaluation, the 21-day No-Observed-Effect Concentration (NOEC) was equal to 0.18 mg/L.
The study was re-evaluated with the statistic programme ToxRat® Professional (version 3.2.1) in order to see whether the study is still valid and complies with requirements of the current OECD 211 guideline. The present report provides the re-calculated endpoints as well as the detailed data of the statistical evaluation. The study is considered valid as the following validity criteria were met:
1) the maximum control mortality in females must not exceed 20 % (actual 0 %), and
2) the mean offspring number at day 21 must be at least 60.0 (actual 75.1).
With respect to these criteria, the test is valid.
The nominal test item concentrations were 0.18, 0.56, 1.8, 5.6, and 18 mg/L. All test item treatment groups were analysed. As the measured concentrations differed to more than 20 % from the nominal concentrations, the reported biological results are related to the geometric mean measured concentrations of the test item (0.161, 0.476, 1.64, 5.22, and 16.2 mg/L).
The EC10, EC20 and EC50 values for the endpoint immobility were 1.63, 1.96 and 2.77 mg/L, respectively. For the endpoint reproduction, the EC10, EC20 and EC50 values were 0.190, 0.215 and 0.273 mg/L, respectively. The NOEC values for immobility and reproduction were 1.64 and 0.161 mg/L, respectively.
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