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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
toxicity to microorganisms, other
Remarks:
toxicity control from biodegradation in water screening test is used to derive effect concentration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-12-02 to 2004-12-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test) (adopted July 17, 1992)
Deviations:
no
Principles of method if other than guideline:
From biodegradation in water: screening test, toxicity control is used to derive effect concentration
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
activated sludge of a predominantly domestic sewage
Details on inoculum:
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Municipal sewage treatment plant, D-31137 Hildesheim
- Pretreatment: The activated sludge was maintained in an aerobic condition by aeration for four hours and then homogenized with a mixer. The sludge was filtered and the filtrate (30 mL) was subsequently used to initiate inoculation.
- Concentration of sludge: 1E07-1E08 CFU/L in inoculum; 1E05-1E06 CFU/L in test vessels
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
28 d
Test temperature:
20 - 24°C
pH:
7.56 - 7.59 (test item), 7.51 - 7.59 (control), 7.86 (functional control), 7.83 (toxicity control)
Nominal and measured concentrations:
45 mg/L (11.8 mg C/L), nominal
Details on test conditions:
TEST CONDITIONS
- Composition of medium: Mineral nutrient solution acc. to OECD 301 B/CO2 Evolution Test
- Additional substrate: no
- Test temperature: 20 - 24°C, continuously stirred
- pH: 7.56 - 7.59 (test item), 7.51 - 7.59 (control), 7.86 (functional control), 7.83 (toxicity control)
- pH adjusted: no
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: 5000 mL, brown glass; fill volume 3000 mL
- Number of culture flasks/concentration: dupilcate (test item)
- Method used to create aerobic conditions: The vessels were connected to the system for the production of CO2 free air and aerated for 24 h.
- Details of trap for CO2 and volatile organics if used: The CO2 adsorption vessels were connected to the air outlets of the incubation vessels via a series of 3 gas wash bottles.

SAMPLING
- Sampling frequency: three times a week during the first ten days and thereafter twice weekly + on day 29

CONTROL AND BLANK SYSTEM
- Inoculum blank: Nutrient solution and inoculum, duplicates
- functional control: Sodium acetate, 35 mg/L (10.2 mg C/L), single replicate
- Toxicity control: Sodium acetate, 35 mg/L (10.2 mg C/L) + test item 45 mg/L (11.8 mg C/L), single replicate
Reference substance (positive control):
no
Key result
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
45 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Remarks on result:
other: comparison of procedural and toxicity control
Details on results:
The biodegradation of the item mixture in the toxicity control was found to be 63 % after 14 days of incubation and came to a maximum of 85 % after 28 days. Thus, according to the test guidelines, the test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 45 mg/L, as the biodegradation in the toxicity control was higher than 35% within 14 days of incubation.

Validity criteria fulfilled:
yes
Conclusions:
The toxicity of C8-10 Alkylamidopropyl betaine to microorganisms was investigated during a ready biodegradation study. The test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 45 mg/L.
Executive summary:

The toxicity of C8-10 Alkylamidopropyl betaine (35% a.i.) to microorganisms was investigated during a ready biodegradation study (CO2 Evolution Test) according to OECD guideline 301 B (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

Inoculum blank, procedural/functional control with the reference substance Sodium acetate and a toxicity control with 45 mg/L test item and 35 mg/L reference item Sodium acetate were performed.

The reference item degraded normally (68% within 14 days). By the end of the test, the reference item was degraded by 82%.

The biodegradation of the item mixture in the toxicity control was found to be 63% after 14 days of incubation. Thus, according to the test guidelines, the test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 45 mg/L, as the biodegradation in the toxicity control was higher than 35% within 14 days of incubation.

Description of key information

14 d NOEC > 45 mg a.i./L, OECD TG 301 B, GLP, RL1

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:
45 mg/L

Additional information

The toxicity of C8-10 Alkylamidopropyl betaine (35% a.i.) to microorganisms was investigated during a ready biodegradation study (CO2 Evolution Test) according to OECD guideline 301 B (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

Inoculum blank, procedural/functional control with the reference substance Sodium acetate and a toxicity control with 45 mg/L test item and 35 mg/L reference item Sodium acetate were performed.

The reference item degraded normally (68% within 14 days). By the end of the test, the reference item was degraded by 82%.

The biodegradation of the item mixture in the toxicity control was found to be 63% after 14 days of incubation. Thus, according to the test guidelines, the test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 45 mg/L, as the biodegradation in the toxicity control was higher than 35% within 14 days of incubation.