Registration Dossier

Environmental fate & pathways

Biodegradation in water: screening tests

Administrative data

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
Deviations:
not specified
GLP compliance:
no
Remarks:
The Study was not performed under the purpose of REACH. Therfore a GLP study was not necessary

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: JHF-713-287
- Expiration date of the lot/batch: unknown
- Purity test date: 100%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: stable

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
sewage, domestic (adaptation not specified)
Details on inoculum:
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure):
- Laboratory culture:
- Method of cultivation:
- Storage conditions:
- Storage length:
- Preparation of inoculum for exposure:
- Pretreatment:
- Concentration of sludge:
- Initial cell/biomass concentration:
- Water filtered: yes/no
- Type and size of filter used, if any:
Duration of test (contact time):
ca. 28 d
Initial test substance concentration
Initial conc.:
ca. 2 mg/L
Based on:
ThOD
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
TEST CONDITIONS
- Composition of medium: concentrated mineral stock solutions were added to reagent water to provide essential mineral nutrients and trace elements necessary to sustain the inoculum through the test period.
- Test temperature: 20°C
- pH: initial : between 7.44 and 7.57
- pH adjusted: no
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus:
- Number of culture flasks/concentration:
- Method used to create aerobic conditions:
- Method used to create anaerobic conditions:
- Measuring equipment:
- Test performed in closed vessels due to significant volatility of test substance:
- Test performed in open system:
- Details of trap for CO2 and volatile organics if used:
- Other:

SAMPLING
- Sampling frequency:
- Sampling method:
- Sterility check if applicable:
- Sample storage before analysis:
- Other:

CONTROL AND BLANK SYSTEM
- Inoculum blank:
- Abiotic sterile control:
- Toxicity control:
- Other:

STATISTICAL METHODS:
Reference substance
Reference substance:
benzoic acid, sodium salt

Results and discussion

% Degradation
Key result
Parameter:
% degradation (test mat. analysis)
Value:
ca. 29.9
Sampling time:
28 d

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Interpretation of results:
inherently biodegradable, not fulfilling specific criteria
Conclusions:
The percent degradation for the hydrogenated jojoba oil test substance treatment on Days 7, 14, 21, and 28 was 0.6, 18.7, 26.5, and 29.9%,respectively.
Since the biodegradation values were less than 60% but greater than 20% ThOD by Day 28 of the study, the test substance exhibits characteristics of an inherently biodegradable material, but it cannot be classified as readily biodegradable by the results of this study according to the criteria specified in the guidelines (1 and 2).