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EC number: 283-144-9 | CAS number: 84540-50-1
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-10-19 to 2016-10-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-amino-2-chlor-6-methylphenol
- EC Number:
- 283-144-9
- EC Name:
- 3-amino-2-chlor-6-methylphenol
- Cas Number:
- 84540-50-1
- Molecular formula:
- C7H8ClNO
- IUPAC Name:
- 3-amino-2-chloro-6-methylphenol
- Test material form:
- solid
- Details on test material:
- Name of test material (as cited in the report): A094 5-Amino-6-chloro-o-cresol
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test item
All concentration levels and the control were analytically verified via HPLC-DAD at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours). The method was validated prior to this study according to SANCO 3029/99 rev.4 (2000).
Sampling for the analytical monitoring
At the start of the exposure intervals (0 and 24 hours), sampling was carried out after preparation of the test item concentrations. At the end of the exposure intervals (24 and 48 hours), samples were taken from additional replicates, which were prepared for the sampling of the aged media with test media, but without daphnids, and incubated under test conditions until sampling.
Range (target)
Recoveries of the test item should be within ± 20% of the nominal concentrations.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Stock solution
A stock solution (10.0 mg/L of the test item were weighed out) was freshly prepared with dilution water (see Table 2) prior to each exposure interval (0 and 24 hours). The stock solution was treated with ultrasound for 10 minutes at room temperature.
Test concentrations
5 test item concentrations in a geometric series with a separation factor of 2, prepared by diluting the stock solution of 10.0 mg/L with dilution water, were tested as follows:
0.625 - 1.25 - 2.50 - 5.00 - 10.0 mg/L.
The test concentrations were selected based on the results of a non-GLP preliminary range finding test.
Control
Dilution water without test item incubated under the same conditions as the test groups
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test system
Daphnia magna STRAUS (Clone 5)
Reason for the selection of the test system
Daphnia magna is the preferred species in accordance with the test guideline and is bred at the test facility.
Origin
Institut für Wasser-, Boden- und Lufthygiene (WaBoLu),
14195 Berlin, Germany
Breeder
Noack Laboratorien GmbH,
Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
Culture
In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 2 °C, in an incubator, 16 hours illumination; light intensity of max. 1500 lx
Culture medium
Elendt M4, according to OECD 202, Annex 3 (2004), modified to a total hardness of 160 to 180 mg CaCO3/L, is used.
Culture feeding
The culture daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 106 cells/mL. The algae were cultured at the test facility.
Origin of the food algae
Sammlung von Algenkulturen (SAG),
Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, 37073 Göttingen, Germany
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- see any other information on material and methods incl. tables
- Test temperature:
- see any other information on material and methods incl. tables
- pH:
- see any other information on material and methods incl. tables
- Dissolved oxygen:
- see any other information on material and methods incl. tables
- Conductivity:
- see any other information on material and methods incl. tables
- Nominal and measured concentrations:
- Nominal: 0.625 - 1.25 - 2.50 - 5.00 - 10.0 mg/L
Geometric mean measured concnetrations: 0.632 - 1.28 - 2.61 - 5.23 - 10.5 mg/L - Details on test conditions:
- Test method
The study was performed with a semi-static test design (with a renewal of the test solutions after 24 hours) as a worst-case exposure.
Test duration
48 hours
Test vessels
Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
Test volume
20 mL in each test replicate (see ‘Application’)
Dilution water
Same as culture medium
Number of daphnids and replicates
20 daphnids, divided into 4 replicates, each with 5 daphnids, were used for each loading level and the control.
Age of the daphnids
Less than 24 hours old daphnids from a healthy stock were used for at the start of the exposure the study. Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period of max. 24 hours preceding the exposure were used for the test. No first brood progeny was used for the test.
Acclimatization
Acclimatization of the daphnids was not necessary, because the dilution water was equivalent to the culture medium.
Application
20 g test solution per replicate was weighed out into each test vessel. This corresponds to 20 mL per test vessel. The daphnids were inserted with a small amount of dilution water (start of the exposure) or test solution (water renewal) by pipette.
Test temperature (target)
18 - 22 °C, constant within ± 1 °C
Illumination (target)
Diffuse light, light intensity of max. 1500 lx
Photoperiod (target)
16/8 hours light/dark cycle
Feeding
The daphnids were not fed during the study. - Reference substance (positive control):
- yes
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 2.82 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: < 0.625 - 4.39
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 2.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: < 0.625 - 3.04
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 2.95 - >10.0
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.53 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 3.04 - 4.07
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- The percentage of immobility for the reference item potassium dichromate (SIGMA-ALDRICH, batch number MKBV0900V, purity 99.0%, CAS RN 7778-50-9) was determined after 24 hours from 2016 10-18 to 2016-10-19.
EC50-Value (with 95% confidents limits) of the Reference Item Potassium dichromate
based on nominal concentrations mg/L, (0 - 24 hours)
Current Study Valid Range
EC50 1.26 mg/L
0.6 - 2.4 mg/L, acc. to AQS P 9/2 (02/2000)
0.6 - 2.1 mg/L, acc. to OECD 202 (2004)
95% confidence limits 1.04 - 1.45 mg/L
- Reported statistics and error estimates:
- Methods of evaluation
The EC100-values (after 24 and 48 hours) were empirically derived from the observation data. All effect concentrations (EC10 / 50 / 100) given are based on the nominal test item concentrations, since the measured test item concentrations were stable within ± 20% of the nominal concentrations. The concentration-effect relationships of the test item after 24 and 48 hours is shown graphically. Additionally, the effect concentrations are presented based on the geometric mean measured test item concentrations, due to the sponsor’s request.
NOEC
The NOEC was determined as the highest test item concentration resulting in ≤ 10% immobility. The NOEC was empirically derived from the observation data.
EC-values and statistical statistical analyses
The EC10- and the EC50-values (after 24 and 48 hours) were calculated by sigmoidal dose-response regression with the software GraphPad Prism5. The respective 95% confidence limits were calculated from the standard error and the t distribution. All calculations were carried out from the best-fit values with the software GraphPad Prism5. The concentration-effect relationships after 24 and 48 hours are shown graphically. The EC50-value for the reference item and its 95% confidence limits were calculated accordingly.
Software
All data were computer-processed and rounded for presentation. Consequently, minor variations may occur from the original figures if manual calculations based on the original figures are made subsequently. Calculations were made using the following software:
- GraphPad Prism5, GRAPHPAD SOFTWARE, INC.
- Excel, MICROSOFT CORPORATION
Any other information on results incl. tables
Immobilization Rates after 24 and 48 hours of Exposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
A094 5-Amino-6-chloro-o-cresol Nominal test item concentration [mg/L] |
IMMOBILIZATION [%] |
|||||||||
24 hours |
48 hours |
|||||||||
Replicates |
Replicates |
|||||||||
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
|
10.0 |
60 |
60 |
60 |
40 |
55 |
100 |
100 |
100 |
100 |
100 |
5.00 |
60 |
100 |
40 |
0 |
50 |
100 |
100 |
80 |
80 |
90 |
2.50 |
0 |
20 |
0 |
0 |
5 |
0 |
20 |
20 |
20 |
15 |
1.25 |
0 |
0 |
0 |
0 |
0 |
20 |
0 |
20 |
0 |
10 |
0.625 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
5 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Additional Observations during the Definitive Test
All tested concentration levels were visually clear throughout the exposure.
Measured Exposure Concentrations during the Definitive Test
The concentrations of the test item A094 5-Amino-6-chloro-o-cresol were analytically verified via HPLC-DAD at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours) in all concentration levels and in the control.
The measured concentrations of the test item were in the range of 100 to 107% of the nominal values at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours).
The measured test item concentrations were all within±20% of the nominal concentrations. This indicates that the test item concentrations were successfully maintained for the duration of the test.
Measured Concentrations and Percent of Nominal Concentration of the Test ItemA0945‑Amino-6-chloro-o-cresolduring the Definitive Test
Sampling date |
2016-10-19 Start of the exposure interval 0 hours |
2016-10-20 End of the exposure interval 24 hours |
2016-10-20 Start of the exposure interval 24 hours |
2016-10-21 End of the exposure interval 48 hours |
Geometric mean measured test item concentration [mg/L] |
||||
Start of analysis |
2016-10-19 |
2016-10-20 |
2016-10-20 |
2016-10-21 |
|||||
Nominal test item concentration [mg/L] |
A094 5‑Amino-6-chloro-o-cresol |
||||||||
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
||
10.0 |
10.5 |
105 |
10.5 |
105 |
10.5 |
105 |
10.4 |
104 |
10.5 |
5.00 |
5.33 |
107 |
5.28 |
106 |
5.16 |
103 |
5.17 |
103 |
5.23 |
2.50 |
2.65 |
106 |
2.64 |
106 |
2.59 |
103 |
2.57 |
103 |
2.61 |
1.25 |
1.31 |
105 |
1.29 |
103 |
1.26 |
101 |
1.25 |
100 |
1.28 |
0.625 |
0.623 |
100 |
0.627 |
100 |
0.649 |
104 |
0.628 |
100 |
0.632 |
Control |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
|
Meas. conc.= measured concentration of the test item, mean value of 2 injections, dilution factors taken into account
% = percent of the nominal concentration of the test item
LOQ = limit of quantification of the analytical method (0.3 mg/L of the test item)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the nominal concentrations of the test item A094 5-Amino-6-chloro-o-cresol, the 48 hour-EC50 for Daphnia magna was 3.53 mg/L (95% confidence limits: 3.04 - 4.07 mg/L).
Based on the geometric mean measured concentrations of the test item A094 5-Amino-6-chloro-o-cresol, the 48 hour-EC50 for Daphnia magna was 3.69 mg/L (95% confidence limits: 3.18 - 4.25 mg/L). - Executive summary:
In the acute immobilization test withDaphnia magna (STRAUS), the effects of the test itemA094 5‑Amino-6-chloro-o-cresol (batch number:20151025) were determined at the test facility according to OECD 202 (2004) from2016-10-19 to 2016-10-21.
The study was conducted under semi-static conditions over a period of 48 hours with 5 concentrations of the test itemA094 5-Amino-6-chloro-o-cresolin the range of 0.625 - 10.0 mg/L, prepared in a geometric series with a separation factor of 2.
All tested concentration levels were visually clear throughout the exposure.
Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration leveland the control.
The concentrations of the test item A094 5-Amino-6-chloro-o-cresol were analytically verified via HPLC-DAD at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours) in all concentration levels and in the control.
The measured concentrations of the test item were in the range of 100 to 107% of the nominal values at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (0 and 24 hours).
The measured test item concentrations were all within ± 20% of the nominal concentrations. This indicates that the test item concentrations were successfully maintained for the duration of the test. Therefore, all effect concentrations are based on the nominal concentrations of the test item A094 5-Amino-6-chloro-o-cresol. Additionally, the effect concentrations are presented based on the geometric mean measured test item concentrations, due to the sponsor’s request.
The validity criteria of the test guideline were fulfilled.
EC10-, EC50-(with 95% Confidence Limits), EC100-Valuesand NOEC
(based on the nominal and the geometric mean measured concentrations of the test item)
A0945-Amino-6-chloro-o-cresol
Effect concentrations
Test
duration
[hours]
Nominal
test item concentrations
[mg/L]
Geometric mean measuredtest item concentrations
[mg/L]
NOEC
24
2.50
2.61
48
1.25
1.28
EC10
(with 95% confidence limits)24
2.82
(Cl: < 0.625 - 4.39)
2.94
(Cl: < 0.632 - 4.59)
48
2.10
(Cl: < 0.625 - 3.04)
2.19
(Cl: < 0.632 - 3.18)
EC50
(with 95% confidence limits)24
5.00
(Cl: 2.95 - > 10.0)
5.23
(Cl: 3.09 - > 10.5)
48
3.53
(Cl: 3.04 - 4.07)
3.69
(Cl: 3.18 - 4.25)
EC100
24
> 10.0
> 10.5
48
10.0
10.5
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