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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 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:
- 23 March 2015 - 1 April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- 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 tested material (as cited in study report): Acilian (4-Amino-5-ethylsulfonyl-2-methoxybenzoic acid)
- batch No.of test material:HS00001
- Expiration date of the lot/batch:January 19, 2016
- Purity test date:February 12,2015
- Purity: 98.0 – 101.5% (nominal)
99.7% (analytical), according to certificate of analysis
0.1% water content
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:100 mg test item/L
- Sampling method:
Analysis of the Test Item Concentrations
Duplicate samples from the freshly prepared test media of the only test concentration and the control were taken at the start of the test and at day 3 (96 hours).All test medium samples were taken from the approximate centre of the aquaria.All samples were diluted with acetonitrile by a factor of 2.One additional sample of the blank control and the dilution solvent was taken at test start and test end without any sample treatment.
Two stock solutions were prepared. Approximately 50 mg of the test item were dissolved (2 minute ultrasonification, 91 minutes stirring) in 50 mL test water to obtain a stock solution of approximately 1 g test item/L. Appropriate amounts of these stock solutions were diluted with test water to obtain fortified samples at a level of 50 and 140 mg test item/L.
Standard Solutions used for the Quantification
Stock Solution:50.08 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 80 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.Fortified samples and analytical blank control samples: The samples were shaken well and were diluted with acetonitrile by factor 2.
- Sample storage conditions before analysis:All samples were stored in a freezer (≤ - 10 °C), protected from light until analysis was performed. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
-Method:A test solution of nominal 100 mg/L was prepared by dissolving 1048.5, 1019.6, 1013 and 1012 mg of the test item homogeneously in 10.485, 10.196, 10.130 and 10.120 L test water by intense stirring for 2 hours and partial ultrasonic treatment for 5 minutes. The pH of the stock solution was adjusted to pH 8.0 ± 0.1 using 2 M NaOH. The test medium was prepared just before introduction of the test fish (= start of the test and test medium renewal on day 1, 2 and 3). Tested concentration was 100 mg/L test item.
- Controls:Reconstituted water (test water was used without addition of the test item)
- Differential loading:< 1 g fish/L test water
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No remarkable observations were made concerning the appearance of the test media.
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name:Rainbow trout (Oncorhynchus mykiss)
- Source:Forellenzuchtbetrieb Störk, 88348 Bad Saulgau, Germany
- Age at study initiation : Juveniles,Male and female
- Length at study initiation : 5.05 cm ± 0.3 cm(Mean ± SD)
- Weight at study initiation :1.19 g ± 0.2 g (Mean ± SD)
ACCLIMATION
- Acclimation period:12 days,They were held in water of the quality to be used in the test for at least seven days immediately before testing.
- Acclimation conditions (same as test or not):No
Light: 16 hours photoperiod daily
Temperature: 13 - 17 °C
Oxygen concentration: at least 80 % of the air saturation value
- Feeding frequency during acclimation: yes, three times per week or daily until 24 hours before the test was started.
- Health during acclimation (any mortality observed):NO
FEEDING DURING THE TEST :none - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 2.5 mmol/L (= 250.0 mg/L) as CaCO3
- Test temperature:
- 14 to 15 °C
- pH:
- 7.8 to 8.1
- Dissolved oxygen:
- 93 to 100 % of the air saturation value during the test
- Conductivity:
- ≤ 10 μScm-1
- Nominal and measured concentrations:
- Nominal:100 mg test item/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Material, size, headspace, fill volume: Glass, 12 litre with 10 litre test medium
- Aeration: yes, slightly stirring
- No. of organisms per vessel:7
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:ISO Medium was prepared according to OECD Test Guideline No 203
- Alkalinity:0.8 mmol/L
- Ca/mg ratio:4 : 1 (based on molarity)
- CaCl2 × 2H2O : 2.0 mmol/L (= 294.0 mg/L)
- MgSO4 × 7H2O : 0.5 mmol/L (= 123.0 mg/L)
- NaHCO3 : 0.75 mmol/L (= 65.0 mg/L)
- KCl : 0.075 mmol/L (= 5.8 mg/L)
Ratio of Ca : Mg = 4 : 1 (based on molarity)
Na : K = 10 : 1 (based on molarity)
OTHER TEST CONDITIONS
- Adjustment of pH: Yes,pH of the stock solution was adjusted to pH 8.0 ± 0.1 using 2 M NaOH
- pH : 7.8 to 8.1
- Photoperiod:16 h light : 8 h dark; 30 min dawn/dusk period was provided
- Light intensity:370 to 690 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and sublethal effects (at test start and after approximately 2, 24, 48, 72 and 96 hours),NOEC after 96 h, LOEC after 96 h; LC50: lethal concentration producing 50 % mortality after 96 h of exposure, LC0, LC 10 and LC100.
TEST CONCENTRATIONS
- Range finding study: NO, the lowest EC50 value of existing relevant algae or acute invertebrate (e.g. daphnia) tests was set as threshold concentration.
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study:Since all EC50 values of existing relevant algae or acute invertebrate (e.g. daphnia) tests are above 100 mg test item/L, the only tested concentration was 100 mg test item/L.This threshold approach was performed in order to demonstrate that the test item had no toxic effects on the test fish up to 100 mg test item/L. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- ca. 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: NO
- Observations on body length and weight:No
- Other biological observations: Dark colouration was observed in two fish after 24 h and in seven fish after 72 hour.
- Mortality of control: NO
- Other adverse effects control: It was observed after 96 hours that two fish were mainly on the bottom.
- 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. - Sublethal observations / clinical signs:
Table No.2: Mortality and Sublethal Effects
Mortality and Sublethal Effects
Nominal Concentration [mg test item/L]
Control
100
0 h
# mort
0
0
# symp
0
0
symp
-
-
2 h
# mort
0
0
# symp
0
0
symp
-
-
24 h
# mort
0
0
# symp
0
2
symp
-
DC
48 h
# mort
0
0
# symp
0
0
symp
-
-
72 h
# mort
0
0
# symp
0
7
symp
-
DC,MB
96 h
# mort
0
0
# symp
0
2
symp
-
MB
# mort: Number of dead fish
# symp: Number of fish with sublethal effects
AP: apathy
CO: convulsions
DA: distended abdomen
DC: dark colouration
EG: strongly extended gills
EX: exophthalmus
FF: fins clearly shortened or frayed out at the border
MB: fish mainly on the bottom
MS: mucous secretion
SB: fish lying on side or back on the bottom
SV: hyperventilation
TS: tumbling during swimming
WS: fish mainly at the water surface
Table No.3: Temperature [°C] in the Test Media
Nominal Concentration [mg test item/L]
Water temperature [°C]
0h
24h
48h
72h
96h
Control
new
15
15
15
15
-
aged
-
15
15
15
15
100
new
14
15
15
15
-
aged
-
15
15
15
15
Table No.4: pH-Values in the Test Media
Nominal Concentration [mg test item/L]
pH value
0h
24h
48h
72h
96h
Control
new
8.0
8.0
8.0
8.0
-
aged
-
7.9
7.9
8.0
8.0
100
new
8.0
7.9
8.1
8.0
-
aged
-
7.8
7.9
7.9
7.8
Table No.5: Dissolved Oxygen Concentrations [%] in the Test Media
Nominal Concentration [mg test item/L]
O2[%]
0h
24h
48h
72h
96h
Control
new
100
99
98
100
-
aged
-
97
96
99
96
100
new
96
97
97
93
-
aged
-
99
98
98
99
Table No.6: Appearance of the Test Item in Test Medium
Nominal Concentration [mg test item/L]
Appearance of the Test Item in the Test Media
0h
24h
48h
72h
96h
100
new
0
0
0
0
-
aged
-
0
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
7: Test item caused foaming
+: Effects were strongly pronounced
Effects in parenthesis were only slightly pronounced
Table 7. Results for the Determination of the Test Item in the Test Samples
Sample Description
[mg test item/L]
Age
Day h
Concentration
Found
[mg test item/L]1
D.F.
Concentration
calculated
[mg test item/L]1
Concentration
nominal
[mg test item/L]
% 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)
1
24
<LOD
2
n.a.
0.000
n.a.
Control (diluted)
1
24
<LOD
2
n.a.
0.000
n.a.
Control (diluted)
3
0
<LOD
2
n.a.
0.000
n.a.
Control (diluted)
3
0
<LOD
2
n.a.
0.000
n.a.
Control (diluted)
4
24
<LOD
2
n.a.
0.000
n.a.
Control (diluted)
4
24
<LOD
2
n.a.
0.000
n.a.
100
0
0
52.804
2
105.609
100.000
106
100
0
0
52.627
2
105.254
100.000
105
100
1
24
52.529
2
105.057
100.000
105
100
1
24
52.609
2
105.218
100.000
105
100
3
0
53.445
2
106.891
100.000
107
100
3
0
53.233
2
106.466
100.000
106
100
4
24
53.346
2
106.693
100.000
107
100
4
24
53.584
2
107.168
100.000
107
mean value (n=8):
106
RSD (n=8):
1
1 The tabulated results represent rounded results calculated on the exact raw data
2 The results represent rounded values
LOD: Limit of Detection = 1.1 mg test item/L
n.a.: not applicable; RSD: Relative Standard Deviation; D.F.: Dilution factor
Table 8. Results for the Determination of the Test Item in the Fortified Samples
Sample 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]
% 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
50
25.318
2
50.636
50.070
101
Fortified Sample
50
25.082
2
50.164
50.070
100
Fortified Sample
50
24.981
2
49.962
50.030
100
Fortified Sample
50
25.172
2
50.344
50.030
101
Fortified Sample
50
25.461
2
50.922
50.030
102
mean value (n=5):
101
RSD (n=5):
1
Fortified Sample
140
70.075
2
140.149
140.196
100
Fortified Sample
140
70.891
2
141.781
140.196140.084
101
Fortified Sample
140
70.051
2
140.102
140.084
100
Fortified Sample
140
68.981
2
137.961
140.084
98
Fortified Sample
140
68.853
2
137.706
98
mean value (n=5):
99
RSD (n=5):
1
Overal mean value (n=8):
100
RSD (n=8):
1
1 The tabulated results represent rounded results calculated on the exact raw data
2 The results represent rounded values
LOD: Limit of Detection = 1.1 mg test item/L
n.a.: not applicable; RSD: Relative Standard Deviation; D.F.: Dilution factor
- Validity criteria fulfilled:
- yes
- Remarks:
- The mortality in the controls must not exceed 10% (mortality=0% during the test), DOC <=60% of the air-saturation value throughout. (93 to 100 % of the air saturation value during the test)
- Conclusions:
- The test item does not cause the mortality at the concentrations 100mg/l. The LC50>100mg/l .
- Executive summary:
In accordance with OECD guideline 203 and GLP study, the test item was tested to demostrate that it has no toxic effect on the test fish up to the threshold concentration of 100 mg test item/L. The single-concentration test (limit test) was performed. It was based on the derivation of a threshold concentration from relevant algae and acute invertebrate (e.g. daphnia) tests at which fish toxicity was tested. Two treatment group were used in this study (one test item concentration at nominal 100 mg/L and one control) each containing 7 individuals. The acute toxicity to unfed juvenile Rainbow Trout was determined in an aerated, semi static, 96-hour test. The tested fish were observed at test start and after approximately 2, 24, 48, 72 and 96 hours test duration for sublethal effects and mortality. The samples of the test medium were analysed via HPLC-method. Measured parameters in this study: 96-hour LC50: > 100 mg test item/L (nominal) 96-hour LC10: > 100 mg test item/L (nominal), 96-hour LC0: 100 mg test item/L (nominal), 96-hour LC100: > 100 mg test item/L (nominal), 96-hour NOEC: 100 mg test item/L (nominal), 96-hour LOEC: > 100 mg test item/L (nominal). It was observed after 96 hours that two fish were mainly on the bottom. The test item does not cause the mortality at the concentration 100 mg test item/L.
Reference
Description of key information
Key study: The test item does not cause the mortality at the concentrations 100 mg test item/L. LC50 (96h) >100 mg/L
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
Key study: In accordance with OECD guideline 203 and GLP study, the test item was tested to demostrate that it has no toxic effect on the test fish up to the threshold concentration of 100 mg test item/L. The single-concentration test (limit test) was performed. Two treatment group were used in this study (one test item concentration at nominal 100 mg/L and one control) each containing 7 individuals. The acute toxicity to unfed juvenile Rainbow Trout was determined in an aerated, semi static, 96-hour test. The tested fish were observed at test start and after approximately 2, 24, 48, 72 and 96 hours test duration for sublethal effects and mortality. The samples of the test medium were analysed via HPLC-method. In the control and the only test concentration of 100 mg test item/L, all fish survived until the end of the experiment. It was observed after 96 hours that two fish were mainly on the bottom. The result of the test: LC50 (96h) >100 mg/L
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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.