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Ecotoxicological information

Toxicity to microorganisms

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Endpoint:
activated sludge respiration inhibition testing
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From March 06, 1997 to March 12, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
activated sludge
Details on inoculum:
- From community water treatment plant in Hildesheim, Germany
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
3 h
Test temperature:
18-22°C
Nominal and measured concentrations:
Nominal: 0, 5.8, 10, 18, 32, 58 and 100 mg/L, corresponding to 0, 4.6, 8.0, 14.4, 25.6, 46.4 and 80 mg a.i./L (based on ca. 80% a.i. in test substance)
Details on test conditions:
For method details, kindly refer to the attached background material section of the IUCLID.
Reference substance (positive control):
yes
Remarks:
Copper sulfate pentahydrate
Key result
Duration:
3 h
Dose descriptor:
other: EC20
Effect conc.:
ca. 39 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Remarks on result:
other: equivalent to 31.2 mg a.i./L
Key result
Duration:
3 h
Dose descriptor:
EC50
Effect conc.:
ca. 54 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Remarks on result:
other: 95% confidence interval 41.6 - 45.6 mg/L
Remarks:
equivalent to 43.2 mg a.i./L
Key result
Duration:
3 h
Dose descriptor:
other: EC80
Effect conc.:
ca. 75 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Remarks on result:
other: equivalent to 60 mg a.i./L

For result tables, kindly refer to the attached background material section of the IUCLID.

Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the 3h EC20, EC50 and EC80 (in activated sludge) for the test substance were determined to be 39 mg/L, 54 mg/L and 75 mg/L (nominal), respectively (equivalent to 31.2, 43.2 and 60.0 mg a.i./L, respectively).
Executive summary:

A study was conducted to determine the toxicity tomicroorganisms of the test substance, C18 TMAC (80% active) according to OECD Guideline 209, in compliance with GLP. In this respiration inhibition test, activated sludge was exposed to the test substance at nominal concentrations of 0, 5.8, 10, 18, 32, 58 and 100 mg/L, corresponding to 0, 4.6, 8.0, 14.4, 25.6, 46.4 and 80 mg a.i./L (based on ca. 80% active ingredient) for 3 h. A positive control, copper sulfate pentahydrate was included in the study. No analytical determination of the test substance was performed. Under the study conditions, the 3h EC20, EC50 and EC80 (in activated sludge) for the test substance were determined to be 39 mg/L, 54 mg/L and 75 mg/L (nominal), respectively (equivalent to 31.2, 43.2 and 60.0 mg a.i./L, respectively) (Noack, 1997).

Endpoint:
toxicity to microorganisms, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 22, 1993 to April 23, 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
DIN 38412-8 (Pseudomonas Zellvermehrungshemmtest)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Pseudomonas putida
Details on inoculum:
The strain Pseudomonas putida Migula, DSM 50026 was used as the inoculum. The preculture and the inoculation of the test batch were carried out according to the information in the quoted DIN standard. Before the test, the bacterial culture was neither acclimatized to the test substance nor to the reference substance.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
16 h
Test temperature:
20-22°C
pH:
7.1
Nominal and measured concentrations:
Concentrations (nominal): 0.06 - 15.63 mg/L, corresponding to 0.05 - 12.50 mg/L based on active ingredient.
Reference substance (positive control):
yes
Remarks:
2,4-dichlorophenol
Key result
Duration:
16 h
Dose descriptor:
EC10
Effect conc.:
0.48 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Key result
Duration:
16 h
Dose descriptor:
EC50
Effect conc.:
0.88 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Key result
Duration:
16 h
Dose descriptor:
EC100
Effect conc.:
ca. 1.84 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Results with reference substance (positive control):
The EC50 for reference substance was between 30 and 100 mg/L. An inoculated batch without the addition of a test material served as a control. It was uniform with water batch volume filled. The prescribed measuring ranges were observed both with the reference substance and in the control.
Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the 16h EC10, EC50 and EC100 for the test substance were determined to be 0.6, 1.1 and 2.3 mg/L (nominal), respectively (equivalent to 0.48, 0.88 and 1.84 mg a.i./L, respectively).
Executive summary:

A study was conducted to determine the toxicity to microorganisms of the test substance, C18 TMAC (80% active) according to DIN 38412-8, in compliance with GLP. The experiment was performed in Pseudomonas putida. Microorganisms were exposed to the test substance at nominal concentrations of 0.06 - 15.63 mg/L (corresponding to 0.05 - 12.50 mg a.i./L based on active ingredient) for 16 hours. A positive control, 2,4 dichlorophenol, was also included in the study. The EC50 for reference substance was between 30 and 100 mg/L. An inoculated batch without the addition of a test material served as a control. It was uniform with water batch volume filled. The prescribed measuring ranges were observed both with the reference substance and in the control. No analytical determination of the test substance was performed. Under the study conditions, the 16h EC10, EC50 and EC100 for the test substance were determined to be 0.6, 1.1 and 2.3 mg/L (nominal), respectively (equivalent to 0.48, 0.88 and 1.84 mg a.i./L, respectively) (Voelskow, 1993).

Description of key information

The 16 h EC10 and EC50 value of the test substance for toxicity to micro-organisms, which were determined at 0.6 and 1.1 mg/L (nominal), (equivalent to 0.48 and 0.88 mg a.i./L) respectively, have been considered further for hazard/risk assessment.

Key value for chemical safety assessment

EC50 for microorganisms:
0.88 mg/L
EC10 or NOEC for microorganisms:
0.48 mg/L

Additional information

Study 1. A study was conducted to determine the toxicity tomicroorganisms of the test substance, C18 TMAC (80% active) according to OECD Guideline 209, in compliance with GLP. In this respiration inhibition test, activated sludge was exposed to the test substance at nominal concentrations of 0, 5.8, 10, 18, 32, 58 and 100 mg/L, corresponding to 0, 4.6, 8.0, 14.4, 25.6, 46.4 and 80 mg a.i./L (based on ca. 80% active ingredient) for 3 h. A positive control, copper sulfate pentahydrate was included in the study. No analytical determination of the test substance was performed.Under the study conditions, the 3h EC20, EC50 and EC80 (in activated sludge) for the test substance were determined to be 39 mg/L, 54 mg/L and 75 mg/L (nominal), respectively (equivalent to 31.2, 43.2 and 60.0 mg a.i./L, respectively) (Noack, 1997).

Study 2. A study was conducted to determine the toxicity to microorganisms of the test substance, C18 TMAC (80% active) according toDIN 38412-8, in compliance with GLP.The experiment was performed in Pseudomonas putida. Microorganisms were exposed to the test substance at nominal concentrations of 0.06 - 15.63 mg/L (corresponding to 0.05 - 12.50 mg a.i./L based on active ingredient) for 16 hours. A positive control, 2,4 dichlorophenol, was also included in the study.The EC50 for reference substance was between 30 and 100 mg/L. An inoculated batch without the addition of a test material served as a control. It was uniform with water batch volume filled. The prescribed measuring ranges were observed both with the reference substance and in the control.No analytical determination of the test substance was performed.Under the study conditions, the 16h EC10, EC50 and EC100 for the test substance were determined to be 0.6, 1.1 and 2.3 mg/L (nominal), respectively (equivalent to 0.48, 0.88 and 1.84 mg a.i./L, respectively) (Voelskow, 1993).

Based on the available study results, the 16 h EC10 and EC50 value of the test substance for toxicity to micro-organisms, which were determined at 0.6 and 1.1 mg/L (nominal), (equivalent to 0.48 and 0.88 mg a.i./L) respectively, have been considered further for hazard/risk assessment.