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Biodegradation in water: screening tests

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Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000.07.28 to 2000.08.25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Version / remarks:
Adopted July 1992
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
Batch no.: QX14202042-ISO
Purity: X14DesB30 contained a colloidal mixture of active ingredient, ethanol and water. According to information from sponsor, the purity of the active ingredient X14DesB30 was >89%
Expiry date 2000.31.12
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Details on inoculum:
Activated sludge collected from Usserød sewage treatment plant, Usserød, Denmark
Duration of test (contact time):
ca. 28 d
Initial conc.:
20 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Remarks:
ThOD
Details on study design:
pH: 7.6
T: 22°C+/-1°C
Reference substance:
other: sodium benzoate
Key result
Parameter:
% degradation (O2 consumption)
Remarks:
ThOD
Value:
ca. 83
Sampling time:
28 d
Details on results:
At the end of the 10 day window covering day 1-11, the BOD was 75+/-8% of the ThOD for complete oxidation of the test product. After 28 days, the BOD corresponded to 83+/-3% of the ThOD.
Results with reference substance:
Sodium benzoate was applied as a reference substance: After 14 days, a biodegradation of 93+/-6 % had been reached and after 28 days, a biodegradation of 99+/-9% was reached. Oxygen consumption of activity controls therefore showed that the activity of the inoculum was satisfactory
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
The biodegradation of X14DesB30 was studied according to the OECD Guideline No. 301F (Ready Biodegradability: Manometric Respirometry Test).
At the end of the 10 day window covering day 1-11, the BOD was 75+/-8% of the ThOD for complete oxidation of the test product.
After 28 days, 83+/-3% biodegradation was achieved. This is above 60% and therefore the test product is composed, or mainly composed, of readily biodegradable substances.
Executive summary:

The biodegradation of X14DesB30 was studied according to the OECD Guideline No. 301F (Ready Biodegradability: Manometric Respirometry Test).

At the end of the 10 day window covering day 1-11, the BOD was 75+/-8% of the ThOD for complete oxidation of the test product.

After 28 days, 83+/-3% biodegradation was achieved. This is above 60% and therefore the test product is composed, or mainly composed of readily biodegradable substances.

Sodium benzoate was applied as a reference substance: After 14 days a biodegradation of 93+/-6 % had been reached and after 28 days a biodegradation of 99+/-9% was reached. Oxygen consumption of activity controls therefore showed that the activity of the inoculum was satisfactory.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003.01.16 to 2003.02.13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Version / remarks:
Adopted July, 1992
GLP compliance:
yes
Specific details on test material used for the study:
UM 306-4990
Batch no. MMO404501
Production date 2002.12.19
Purity: > 98%
Dry matter content 94.9%

The test substance is Human Insulin. The test substance name used in the test report is Insulin.
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Details on inoculum:
Activated sludge collected from Usserød sewage treatment plant, Usserød, Denmark
Duration of test (contact time):
28 d
Initial conc.:
20 mg/L
Based on:
ThOD
Remarks:
ThOD-NO3: 42 mg O2/L
Details on study design:
T: 22°C+/-1°C
Reference substance:
other: sodium benzoate
Key result
Parameter:
% degradation (O2 consumption)
Remarks:
ThOD-NO3
Value:
98
Sampling time:
28 d
Details on results:
At the end of the 10 day window covering day 1-11 the BOD was 92+/-1% of the ThOD-NO3 for complete oxydation of the test product. After 28 days the BOD corresponded to 98+/-1% of the ThOD-NO3.
Results with reference substance:
The biodegradation of sodium benzoate was 94.4% and 97.5% after 14 and 28 days, respectively. (BOD of % of ThOD)
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
The biodegradation of Insulin was studied according to the OECD Guideline No. 301F (Ready Biodegradability: Manometric Respirometry Test).
At the end of the 10 day window covering day 1-11 the BOD was 92+/-1% of the ThOD-NO3 for complete oxydation of the test product.
After 28 days 98+/-1% biodegradation was achieved. This is above 60% and therefore Insulin is considered as readily biodegradable.
Executive summary:

The biodegradation of Insulin was studied according to the OECD Guideline No. 301F (Ready Biodegradability: Manometric Respirometry Test).

At the end of the 10 day window covering day 1-11, the BOD was 92+/-1% of the ThOD-NO3 for complete oxidation of the test product. After 28 days 98+/-1% biodegradation was achieved. This is above 60% and therefore Insulin is considered as readily biodegradable.

Sodium benzoate was applied as a reference substance: After 14 days a biodegradation of 94+/-4 % had been reached and after 28 days a biodegradation of 97+/-5% was reached. Oxygen consumption of activity controls therefore showed that the activity of the inoculum was satisfactory.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across: Plese refer to section "Justification for type of information"
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Parameter:
% degradation (O2 consumption)
Value:
> 60
Sampling time:
28 d
Remarks on result:
other:
Remarks:
study result
Validity criteria fulfilled:
not applicable
Interpretation of results:
readily biodegradable
Conclusions:
Insulin Human Methyl Ester is predicted to be readily biodegradable based on the results in the ready biodegradability studies of the source substances (S1, S2, S3).
The biodegradation of Insulin Human Methyl Ester is assumed to follow the same pattern as that of the source substances because of the high degree of structural similarity.
The results from the ready biodegradability studies with the source substances revealed a biodegradability of 98% (S1), 103% (S2) and 83% (S3).
Executive summary:

The biodegradation of Insulin Human Methyl Ester is assumed to follow the same pattern as that of the source substances because of the high degree of structural similarity:

•       Insulin Human Methyl Ester and the source substances belong to the same chemical categories: human insulins, polypeptides and proteins

•       Insulin Human Methyl Ester and the source substances are composed of polypeptide containing amino acids

•       The ready biodegradability prediction is supported by the fact that the amino acids in Insulin Human Methyl Ester and the source substances are readily biodegradable.

Insulin Human Methyl Ester is predicted to be readily biodegradable based on the results in the ready biodegradability studies of the source substances (S1, S2, S3).

The results from the ready biodegradability studies with the source substances revealed a biodegradability of 98% (S1), 103% (S2) and 83% (S3).

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000.07.28 to 2000.08.25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Version / remarks:
Adopted July 1992
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Batch no.: QA204979
Expiry date 2000.12.31
MI3 contained 297 mg active ingredient per g of a purity of 98.62%
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Details on inoculum:
Activated sludge, municipal waste water treatment plant, Usserød, Denmark
Duration of test (contact time):
ca. 28 d
Initial conc.:
20 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Remarks:
ThOD
Details on study design:
pH: 7.6
T: 22°C+/-1°C
Reference substance:
other: sodium benzoate
Key result
Parameter:
% degradation (O2 consumption)
Remarks:
ThOD
Value:
103
Sampling time:
28 d
Remarks on result:
other: 103+/-16%
Details on results:
At the end of the 10 day window covering day 1-11, the BOD was 90+/-7% of the ThOD for complete oxidation of the test product. After 28 days, the BOD corresponded to 103+/-16% of the ThOD. From day 23 to 25 the temperature dropped to 20°C. However, the degradation had already reached the pass level at this time, and therefore it did not influence the result.
Results with reference substance:
Sodium benzoate was applied as a reference substance: After 14 days, a biodegradation of 93+/-6 % had been reached and after 28 days, a biodegradation of 99+/-9% was reached. The oxygen consumption in activity controls showed that the activity of the inoculum was satisfactory.
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
The biodegradation of MI3 was studied according to the OECD Guideline No. 301F.
After 28 days, 103+/-16% biodegradation was achieved. This is above 60% and therefore MI3 is considered as readily biodegradable.
Executive summary:

The biodegradation of MI3 was studied according to the OECD Guideline No. 301F (Ready Biodegradability: Manometric Respirometry Test).

At the end of the 10 day window covering day 1-11, the BOD was 90+/-7% of the ThOD for complete oxidation of the test product.

After 28 days, 103+/-16% biodegradation was achieved. This is above 60% and therefore MI3 is considered as readily biodegradable.

Sodium benzoate was applied as a reference substance: After 14 days, a biodegradation of 93+/-6 % had been reached and after 28 days, a biodegradation of 99+/-9% was reached. Oxygen consumption of activity controls therefore showed that the activity of the inoculum was satisfactory.

Description of key information

The biodegradation of Insulin Human Methyl Ester is assumed to follow the same pattern as that of the source substances because of the high degree of structural similarity:

•       Insulin Human Methyl Ester and the source substances belong to the same chemical categories: human insulins, polypeptides and proteins

•       Insulin Human Methyl Ester and the source substances are composed of polypeptide containing amino acids

•       The ready biodegradability prediction is supported by the fact that the amino acids in Insulin Human Methyl Ester and the source substances are readily biodegradable.

Insulin Human Methyl Ester is predicted to be readily biodegradable based on the results in the ready biodegradability studies of the source substances (S1, S2, S3).

The results from the ready biodegradability studies with the source substances revealed a biodegradability of 98% (S1), 103% (S2) and 83% (S3).

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable

Additional information