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Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

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Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD guidance but not GLP. Specific details relating to the experimental study design are not provided for assessment.
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Deviations:
yes
Remarks:
Increased study duration
GLP compliance:
no
Remarks:
This study was not conducted specifically for REACH registration initially (other regulatory purposes), however the data are considered sufficient to show no biodegradation of the substance.
Oxygen conditions:
aerobic
Inoculum or test system:
natural water
Details on inoculum:
Inoculum: Surface water from Skokie, IL water district.
The proportion and nature of industrial waste in inoculum is unknown, but there is discharge from a waste treatment facility within 1 mile.
Bacterial inoculum: ca. 1E5 cfu/mL
Duration of test (contact time):
31 d
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
TEST CONDITIONS
No details are available on the media composition. The test temperature was detailed as 22°C +/- 2°C, with a Final pH of 7.75. Total carbon analysis value for the test substance was determined to be 81.5%.




Reference substance:
acetic acid, sodium salt
Remarks:
Sodium acetate
Test performance:
The results showed no biodegradation of the test substance by the end of the study.
Key result
Parameter:
% degradation (CO2 evolution)
Value:
ca. 0
Sampling time:
31 d
Details on results:
The results showed no biodegradation of the test substance by the end of the study.
Results with reference substance:
The reference control provided reached 60% (% ThCO2) by Day 14 of the test and 75.5% (+/- 7%) by the end of the test, with a final pH value of 7.6.
Validity criteria fulfilled:
not specified
Interpretation of results:
under test conditions no biodegradation observed
Conclusions:
Under the conditions of the OECD 301B guideline test, no biodegradation of the test substance was observed over a 31 day testing period, using surface water as an inoculum.
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD guidance but not GLP. Specific details relating to the experimental study design are not provided for assessment.
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Deviations:
yes
Remarks:
Increased study duration
GLP compliance:
no
Remarks:
This study was not conducted specifically for REACH registration initially (other regulatory purposes), however the data are considered sufficient to show no biodegradation of the substance.
Oxygen conditions:
aerobic
Inoculum or test system:
not specified
Details on inoculum:
An industrial inoculum was used on test (assumed to be adapted to the test substance).
The micro-organism concentrations were checked on day 0 and 20 of the test and were determined to exceed 1E7 CFU/mL per sample chamber.
Duration of test (contact time):
35 d
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
TEST CONDITIONS
No details are available on the media composition. The test temperature was detailed as 22°C +/- 2°C, with a Final pH of 7.4. Total carbon analysis value for the test substance was determined to be 82%.
Reference substance:
acetic acid, sodium salt
Remarks:
Sodium acetate
Parameter:
% degradation (CO2 evolution)
Value:
0
Sampling time:
35 d
Details on results:
The results showed no biodegradation of the test substance by the end of the study.
Results with reference substance:
The reference control provided reached 60% (% ThCO2) by Day 17 of the test and 72% by the end of the test.
Validity criteria fulfilled:
not specified
Interpretation of results:
under test conditions no biodegradation observed
Conclusions:
Under the conditions of the OECD 301B guideline test, no biodegradation of the test substance was observed over a 35 day testing period, assumed to be using adapted industrial site inocula.

Description of key information

Two ready biodegradation studies are available conducted in accordance with OECD 301B guideline. The information provided in these testing reports is generally deficient with regards to experimental method detail. 

Key value for chemical safety assessment

Biodegradation in water:
under test conditions no biodegradation observed

Additional information

The initial study using the substance has shown no ready biodegradation over a 31 day testing period, based on percent of maximum CO2 evolved (compared with ThCO2). The study was repeated with an extended test period, 35 days (with similar deficiencies in experimental method details). This study also showed no biodegradation of the test substance.

Together these studies show a distinct lack of biodegradation of the substance under aerobic conditions, and as such are considered acceptable to fulfil this specific information requirement.