Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Toxicity to microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
activated sludge respiration inhibition testing
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1st, 2007 - July 4th, 2008
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)
Specific details on test material used for the study:
- Analytical purity: 82.3%
- Purity test date: Not available
- Lot/batch No.: GN-8
- Expiration date of the lot/batch: Not available
- Appearance: Amber coloured, extremely viscous liquid
- Storage: In the dark at room temperature
- Additional information on test material used for the study: It was attempted to purify the substance to a purity of >80% by using an alternative synthetic route, as opposed to the usual commercial route of synthesis which results in a purity of the substance of approximately 40% in water. This alternative synthetic route generated the substance at 82.3% purity, however it also generated an impurity (methanol at 4.0%) which is not present in the commercial substance. Based on the classification and labelling of methanol, it is considered that this additional impurity would not have an influence on any of the endpoints discussed in this dossier other than the acute oral toxicity study. Therefore all studies (including the one covering this endpoint) contained in this dossier (other than the acute oral toxicity study) were conducted on the 82.3% pure substance containing the 4.0% methanol impurity. The acute oral toxicity study has been conducted on the commercially generated substance at a purity of approximately 40% in water.
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Dissolved directly in dechlorinated tap water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No
Test organisms (species):
activated sludge of a predominantly domestic sewage
Details on inoculum:
- Name and location of sewage treatment plant where inoculum was collected: Severn Trent Water Plc sewage treatment plant, Loughborough, Leicestershire, UK
- Method of cultivation: Continuous aeration at 21°C
- Initial biomass concentration: 4.0 g suspended solids/L
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
3 h
Hardness:
140 mg/L as CaCO3
Test temperature:
21 ± 1°C
pH:
7.6-8.0
Nominal and measured concentrations:
Limit test: 1000 mg a.i./L (nominal concentration)
Definitive test: 100 and 1000 mg a.i./L (nominal concentrations)
Details on test conditions:
TEST SYSTEM
- Test vessel: Conical flask (500 mL)
- Fill volume: 500 mL (control: 16 mL synthetic sewage, 200 mL inoculum, 300 mL water; test: 16 mL synthetic sewage, 200 mL inoculum, aliquots of test material stock solutions, water up to 500 mL)
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water, dechlorinated (Purite Series 500 carbon filter) and partly softned (Elga Nimbus 1248D Duplex water softner), passed through a series of computer controlled plate heat exchangers to achieve the required temperature

EFFECT PARAMETERS MEASURED :
Rate of respiration determined after 30 minutes and 3 hours contact time (after 3 hours contact time only in the range-finding tests)

TEST CONCENTRATIONS
- Range-finding test(s): Yes (two)
- Test concentrations (range-finding tests): 1, 10, 100 and 1000 mg/L in the first and second range-finding tests
Reference substance (positive control):
yes
Remarks:
3,5-dichlorophenol
Key result
Duration:
3 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
1-octanamine, N, N-dimethyl-, N-oxide
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Key result
Duration:
3 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
1-octanamine, N, N-dimethyl-, N-oxide
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Details on results:
In the first range-finding test, evidence of inhibition of respiration was observed at all concentrations tested, however the difference in respiration rates between the control and test material vessels was similar to that which could be attributed to normal biological variation between control and test vessels (± 15%). Therefore a second range-finding test was conducted to confirm the results obtained. In the second range-finding test no significant effect on respiration was observed at any of the test concentrations employed. Based on this result, a limit test was conducted at a single concentration of 1000 mg a.i./L. The results of this limit test showed inhibition values between 8% and 12% after 3 hours contact time. As observed in the first range-finding test, the difference between the control and test material respiration rates was within the limits that could be attributed to normal biological variation. However, to confirm that the test material exhibited no adverse effect on the respiration rate of activated sewage sludge, a definitive test was conducted using two test concentrations of 100 and 1000 mg a.i./L.

Results with reference substance (positive control):
The results from the positive control with 3,5-dichlorophenol were within the normal range for this reference material. The 3-hour EC50 value calculated was 7.1 mg/L.

 Results from definitive test:

ECx(30 Minutes) (mg a.i./L)

95% Confidence Limits  

(mg a.i./L)

ECx(3 Hours)  

(mg a.i./L)

95% Confidence Limits  

(mg a.i./L)

EC20

>1000

-

>1000

-

EC50

>1000

-

>1000

-

EC80

>1000

-

>1000

-

NOEC

1000

-

1000

-

Validity criteria fulfilled:
yes
Conclusions:
The 3-hour 50% effective concentration EC50 was greater than 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide) and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.
Executive summary:

The toxicity of the test material to aquatic microorganisms (activated sludge) was determined in a GLP-compliant study performed in accordance with OED Guideline 209. The 3-hour 50% effective concentration EC50 was greater than 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide) and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.

Description of key information

The toxicity of the test material to aquatic microorganisms (activated sludge) was determined in a GLP-compliant study performed in accordance with OED Guideline 209. The 3-hour 50% effective concentration EC50 was greater than 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide) and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:
1 000 mg/L

Additional information

The toxicity of the test material to aquatic microorganisms (activated sludge) was determined in a GLP-compliant study performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1) and was selected as key study for the endpoint.