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EC number: 275-833-8 | CAS number: 71675-87-1
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 February 2015 - 17 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SANCO/3029/99 rev.4 11/07/00: Residues: Guidance for generating and reporting methods of analysis in support of preregistration data requirements for Annex II (part A; Section 4) and Annex III (PART a; Section 5) of directive 91/414
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Name of test material (as cited in study report): Acilian (4-Amino-5-ethylsulfonyl-2-methoxybenzoic acid)
- batch No.of test material:GS00012
- Expiration date of the lot/batch:February 28, 2015
- Purity test date:March 13, 2014
- Purity: 98.0 – 101.5% (nominal)
100.9% (analytical), according to certificate of analysis
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:At room temperature (20 ± 5 °C), in the dark
- Stability under test conditions: yes - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Nominal concentration of the test item: 100mg/L.
- Sampling method:
Analysis of the Test Item Concentrations:
Duplicate samples from the freshly prepared test medium of the only test concentration and the control were taken at the start of the test. For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentration during the test period, duplicate samples from the test medium of the only test concentration and the control were collected at the end of the test (after 48 hours). All samples were diluted by a factor of 2 with acetonitrile. One additional sample of the blank control and the dilution solvent was taken at test start and test end without any sample treatment.
The concentration of the test item was analysed in the duplicate test media samples from the only test concentration, and in the duplicate control samples, from both sampling times (0 and 48 hours).
Fortified Samples:Approximately 50 mg of the test item were dissolved (1 minutes ultrasonic treatment and 15 minutes stirring) in 50 mL test water to obtain a stock solution of approximately 1 g test item/L. Two stock solutions were prepared. Appropriate amounts of these stock solutions were diluted with test water to obtain fortified samples at a level of 40 and 140 mg test item/L. Exact values were documented in the raw data.
Standard Solutions used for the Quantification:
- Stock Solution:49.85 mg of the test item were dissolved in 50 mL acetonitrile to obtain a stock solution of approximately 1 g test item/L.
- Standard Solutions:Appropriate amounts of the stock solution were diluted with acetonitrile / test water (1/1, v/v) to obtain standard solutions in the range from 10 to 70 mg test item/L.
Analysis of treatment samples and control samples.
- Sample Preparation:The samples were allowed to thaw to room temperature.They were then shaken well and treated with ultrasound for 1 minute to obtain homogenous samples. The samples were already diluted with acetonitrile by factor 2 directly after sampling (see chapter 6.10). The samples were diluted further with acetonitrile / test water (1/1, v/v) to match the calibration range, if necessary.
- Sample storage conditions before analysis:All samples were stored in a freezer (≤ - 10 °C), protected from light until analysis was performed.
The quantification of the test item Acilian was performed using liquid chromatography with UV detection. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test medium of the only test concentration of nominal 100 mg test item/L was prepared by dissolving 40 mg test item into 400 mL water by intense stirring for 30 minutes. The test media were prepared just before introduction of the daphnids (= start of the test).
- Controls:Reconstituted water - without addition of the test item.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No remarkable observations were made concerning the appearance of the test media.Test medium was clear throughout the entire test duration. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: 5
- Source: Ibacon's in-house laboratory culture.
- Age of parental stock (mean and range, SD): From 2.5 to 18.25 hours old at test start.
- Feeding during test: The daphnids in the stock culture were fed at least on all working days.
- Food type: green algae (Desmodesmus subspicatus) freshly grown in the laboratories of ibacon.
ACCLIMATION
- Acclimation period: Not needed since since the test was performed in the same medium as the culturing - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Test organisms were considered immobile if they showed no ability to swim within 15 seconds after swirling the test vessel.
- Hardness:
- 2.5 mmol/L (= 250 mg/L) as CaCO3
- Test temperature:
- 20 °C at test start;
20 °C at test end - pH:
- 8.2 at test start;
8.0 at test end; and thus the pH-value did not vary by more than 1.5
units - Dissolved oxygen:
- 9.1 to 9.2 mg/L at test start;
8.9 to 9.0 mg/L at test end - Conductivity:
- conductivity < 5 μScm-1
- Nominal and measured concentrations:
- Nominal : 100 mg test item/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Beakers
- Type (delete if not applicable): closed,covered with a lid to reduce the loss of water due to evaporation and to avoid the entry of dust into the solutions.
- Material, size, headspace, fill volume:Glass, 100mL containing approximately 60 mL of test medium.
- Aeration: STIRRING
- No. of organisms per vessel:5
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:Reconstituted Water (Elendt "M4") was prepared according to OECD Test Guideline No 202
- Alkalinity:0.9 mmol/L
- Conductivity:< 5 μScm-1
- Culture medium different from test medium:No
- Intervals of water quality measurement: Start and end of the test.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod:16 h light / 8 h dark.
- Light intensity:The light intensity was 760 to 850 lux (measured once during the test).
EFFECT PARAMETERS MEASURED: EC50,EC10, NOEC and LOEC.
Number of immobile organisms after 24 and 48 hours -Test organisms were considered immobile if they showed no ability to swim within 15 seconds after swirling the test vessel.
VEHICLE CONTROL PERFORMED: No
RANGE-FINDING TEST
Pre-experiments were performed to determine a suitable concentration range and to establish suitable methods to prepare the test solutions. The pre-experiments were not performed in compliance with the GLP-Regulations and are excluded from the Statement of Compliance in the final report. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: no
After 48 hours of exposure no immobilisation of the test animals was observed in the control and in the only test concentration of nominal 100 mg test item/L.
- Observations on body length and weight:No
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control:No
- Abnormal responses:No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No remarkable observations were made concerning the appearance of the test media.Test medium was clear throughout the entire test duration. - Results with reference substance (positive control):
- - Results with reference substance valid : YES
EC50 [mg/L]:1.85 (24 HOURS) and 1.11 (48 HOURS)
EC20 [mg/L]: 1.68 (24 HOURS), 1.02 (48 HOURS)
EC10 [mg/L]: 1.60 (24 HOURS), 0.976 (48 HOURS)
NOEC [mg/L]: 1.0 (24 HOURS), 0.5 (48 HOURS): determinated from the raw data
LOEC [mg/L]: 2.0 (24 HOURS), 1.0 (48 HOURS): determinated from the raw data - Reported statistics and error estimates:
- No statistical analysis was performed. The EC50 could not be quantified due to the absence of toxicity of the test item. The NOEC and the LOEC were determined directly from the raw data.
- Validity criteria fulfilled:
- yes
- Remarks:
- The dissolved oxygen conc. at the end of the test should be ≥ 3 mg/L (≥ 8.9 mg O2/L obtained) of the air saturation value at the T used. Control immobilisation rate- not more than 10 % (0% obtained).
- Conclusions:
- No immobilized animal observed. The value EC50 (48h) is > 100 mg/L.
- Executive summary:
The study was carried out with principles of GLP studies - OECD Guidelines 202 . The purpose of this study was to evaluate the influence of the test item Acilian on the mobility of Daphnia magna. This limit test was performed in compliance with the test guidelines to demonstrate that the test item has no toxic effect on daphnids up to at least this concentration. Twenty, young Daphnia magna (<24 h old, 5 per replicate) were exposed to either a control medium (test water) and 100 mg test item /L for 48 hours under static conditions. The immobility of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. There were no observed any immobilized animal and the dissolved oxygen concentration at the end of the test in control and test vessels was more than 3 mg/L. All validity criteria were within acceptable limits and therefore the study can be considered as valid. The 48-hour NOEC was determined to be 100mg test item /L. The 48-hour LOEC was determined to be > 100 mg test item/.The EC50 (48h) was determined to be > 100 mg test item /L.
Reference
Table 1. Results of the Determination of the Test Item in the Test Samples
Sample Description [mg test item/L] |
AGE day |
AGE hour |
Concentration found [mg test item/L]1 |
D.F. |
Concentration calculated [mg test item/L]1 |
Concentration nominal [mg test item/L]2 |
% of nominal2 |
Control (diluted) |
0 |
0 |
<LOD |
2 |
N.A. |
0.000 |
N.A. |
Control (diluted) |
0 |
0 |
<LOD |
2 |
N.A. |
0.000 |
N.A. |
Control (diluted) |
2 |
48 |
<LOD |
2 |
N.A. |
0.000 |
N.A. |
Control (diluted) |
2 |
48 |
<LOD |
2 |
N.A. |
0.000 |
N.A. |
100 |
0 |
0 |
52.733 |
2 |
105.466 |
100.000 |
105 |
100 |
0 |
0 |
52.528 |
2 |
105.056 |
100.000 |
105 |
100 |
2 |
48 |
53.138 |
2 |
106.275 |
100.000 |
106 |
100 |
2 |
48 |
52.235 |
2 |
104.470 |
100.000 |
104 |
mean value (n=4):105
RSD (n=4):1
1 The tabulated results represent rounded results calculated on the exact raw data
2 The results represent rounded values
LOD: Limit of Detection = 3.7 mg test item/L
n.a.: not applicable
RSD: Relative Standard Deviation
D.F.: Dilution factor
Table No.2: Results of the Determination of the Test Item in the Fortified Samples
Description
|
[mg test item/L] |
Concentration found [mg test item/L]1 |
D.F. |
Concentration calculated [mg test item/L]1 |
Concentration nominal [mg test item/L]2 |
% of nominal2 |
|||
Analytical Blank Control |
0 |
<LOD |
2 |
n.a. |
0.000 |
n.a. |
|||
Analytical Blank Control |
0 |
<LOD |
2 |
n.a. |
0.000 |
n.a. |
|||
Fortified Sample |
40 |
20.210 |
2 |
40.420 |
39.704 |
102 |
|||
Fortified Sample |
40 |
20.536 |
2 |
41.073 |
39.704 |
103 |
|||
Fortified Sample |
40 |
20.354 |
2 |
40.708 |
40.344 |
101 |
|||
Fortified Sample |
40 |
20.139 |
2 |
40.279 |
40.344 |
100 |
|||
Fortified Sample |
40 |
20.148 |
2 |
40.297 |
40.344 |
100 |
|||
|
mean value (n=5): |
101 |
|
||||||
RSD (n=5): |
1 |
|
|||||||
Fortified Sample |
140 |
32.490 |
2 |
129.960 |
138.964 |
94 |
|||
Fortified Sample |
140 |
35.720 |
2 |
142.882 |
138.964 |
103 |
|||
Fortified Sample |
140 |
36.015 |
2 |
144.062 |
141.204 |
102 |
|||
Fortified Sample |
140 |
36.431 |
2 |
145.725 |
141.204 |
103 |
|||
Fortified Sample |
140 |
36.396 |
2 |
145.584 |
141.204 |
103 |
|||
|
mean value (n=5): |
101 |
|
||||||
RSD (n=5): |
4 |
overall mean value (n=10):101
RSD (n=10):3
1 The tabulated results represent rounded results calculated on the exact raw data
2 The results represent rounded values
LOD: Limit of Detection = 3.7 mg test item/L
n.a.: not applicable
RSD: Relative Standard Deviation
D.F.: Dilution factor
Table No.3: Influence of Acilian on the Mobility of Daphnia magna
Nominal Concentration [mg test item/L] |
No. of Daphnia tested |
No. of immobilised Daphnia after |
% of immobilised Daphnia after |
||
|
|
24h |
48h |
24h |
48h |
Control |
20 |
0 |
0 |
0 |
0 |
100 |
20 |
0 |
0 |
0 |
0 |
Table No.4: Water Temperature in the Test Media at the Start and End of the Test
Nominal Concentration [mg test item/L] |
Water temperatura (ºC) |
|
|
0 h |
48 h |
Control |
20 |
20 |
100 |
20 |
20 |
Table No.5: Dissolved Oxygen Concentrations and pH-Values in the Test Media
Nominal Concentration [mg test item/L] |
0 hours |
48 hours |
||
|
pH |
O2[mg/L] |
pH |
O2[mg/L] |
Control |
8.2 |
9.2 |
8.0 |
8.9 |
100 |
8.2 |
9.1 |
8.0 |
9.0 |
Table No.6: Appearance of Test Item in Test Medium
Nominal Concentration [mg test item/L] |
Appearance of the Test Item in the Test Media |
||
|
0 h |
24 h |
48 h |
100 |
0 |
0 |
0 |
Abbreviations:
0: No remarkable observations, clear test medium
1: Colouration caused by the test item
2: Turbidity caused by the test item
3: Inhomogeneous dispersion of the test item
4: Precipitation of the test item
5: Test item at the surface
6: Test item lying at the bottom of the test vessel
+: Effects were strongly pronounced
Effects in parenthesis were only slightly pronounced
Description of key information
Key study: OECD 202, GLP study, No immobilized animal observed . The estimated 48-h EC50 is > 100 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
Key study: The study was carried out with principles of GLP studies - OECD Guidelines 202. Twenty Daphnia magna (<24 h old, 5 per replicate) were exposed to a control medium and 100 mg test item /L for 48 hours under static conditions. The limit test was performed. The immobility of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. There were no observed any immobilized animal. The dissolved oxygen concentration at the end of the test in control and test vessels was more than 3 mg/L. All validity criteria were within acceptable limits. The 48-hour NOEC was determined to be 100 mg test item/L. The 48-hour LOEC was determined to be > 100 mg test item/L. The EC50 (48h) was determined to be > 100 mg test item/L.
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