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Environmental fate & pathways

Biodegradation in water: screening tests

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Administrative data

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 25 November and 9 December 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under OECD method and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC methods for the determination of ecotoxicity, Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part C, Method C7, Abiotic degradation: hydrolysis as a function of pH; and the estimation of the soil adsorption coefficient (Koc) by HPLC
Principles of method if other than guideline:
The method is only applicable to water soluble substances
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Intended use: Pharmaceutical intermediate
Appearance: White powder
Storage conditions: Room temperature
Purity: 99.4%
Date received: 2 October 1996

Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No Data

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Duration of test (contact time):
28 d
Details on study design:
TEST CONDITIONS
- Test temperature: XX C
- pH: XX
- pH adjusted: yes or no
-Dilution water: HQ deionised water with conductivity of < 10 uS/cm and low carbon content (modfy as needed)

TEST SYSTEM - CHECK thse are the same
- Culturing apparatus: series of glass carboys containing 3 liters of test medium
- Number of culture flasks/concentration: 2 test flasks with test substance and inoculum
- Method used to create aerobic conditions: carbon dioxide free air

CONTROL AND BLANK SYSTEM -check these are the same
- Inoculum blank: yes
- Abiotic sterile control: yes
- Toxicity control: yes
- Other: 1 system blank, 1 procedure blank
Reference substance
Reference substance:
other: Sodium benzoate

Results and discussion

% Degradation
Parameter:
% degradation (CO2 evolution)
Value:
27
Sampling time:
28 d
Details on results:
Points of degradation plot (test substance): vv % degradation after 1 d vv % degradation after 2 d vv % degradation after 3 d vv % degradation after 6 d vv % degradation after 8 d vv % degradation after 10 d vv % degradation after 14 d vv % degradation after 16 d vv % degradation after 20 d vv % degradation after 22 d vv % degradation after 24 d vv % degradation after 27 d vv % degradation after 28 d

BOD5 / COD results

Results with reference substance:
Points of degradation plot (reference substance): vv % degradation after 1 d vv % degradation after 2 d vv % degradation after 3 d vv % degradation after 6 d vv % degradation after 8 d vv % degradation after 10 d vv % degradation after 14 d vv % degradation after 16 d vv % degradation after 20 d vv % degradation after 22 d vv % degradation after 24 d vv % degradation after 27 d vv % degradation after 28 d

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
other:
Conclusions:
The test material attained vv% degradation after 28 days and therefore cannot (or can) be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No 301B.