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Ecotoxicological information

Toxicity to microorganisms

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Endpoint:
activated sludge respiration inhibition testing
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 please refer to section "justification for type of information"
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
30 min
Dose descriptor:
EC10
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Key result
Duration:
180 min
Dose descriptor:
EC10
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Key result
Duration:
30 min
Dose descriptor:
EC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Key result
Duration:
180 min
Dose descriptor:
EC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conclusions:
Insulin Human Methyl Ester is predicted to have a toxicity to microorganisms with EC50 > 500 mg/L based on the results in the study with the source substance S2.

The microbial inhibition of Insulin Human Methyl Ester is assumed to follow the same pattern as that of the source substance S2 (MI3) because of the high degree of structural similarity:
•       Insulin Human Methyl Ester and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
•       Insulin Human Methyl Ester and the source substance are both composed of polypeptide containing amino acids

The resulting EC50 values after 30 minutes and 180 minutes in the microbial inhibition study with the source substance S2 (MI3) were > 500 mg/L.
Executive summary:

The microbial inhibition of Insulin Human Methyl Ester is assumed to be comparable to that of the source substance S2 (MI3) because of the high degree of structural similarity:

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

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

The resulting EC50 values after 30 minutes and 180 minutes in the microbial inhibition study with the source substance S2 (MI3) were > 500 mg/L. Insulin Human Methyl Ester is predicted to have a toxicity to microorganisms with EC50 > 500 mg/L based on the results in the study with the source substance S2.

Furthermore, the biodegradation of the source substances: Human Insulin (S1), MI3 (S2) and X14DesB30 (S3) was studied following the OECD guideline no 301 (please refer to section 5.2.1 for details). During these studies a toxicity control was included (test concentration applied was 20 mg/L). No toxicity was observed towards microorganisms in these studies, indicating that Insulin Human Methyl Ester does not inhibit microorganisms in the concentration range of 20 mg/L.

Endpoint:
activated sludge respiration inhibition testing
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000.08.09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
Version / remarks:
1984
Qualifier:
according to guideline
Guideline:
ISO 8192 (Water quality - Test for inhibition of oxygen consumption by activated sludge for carbonaceous and ammonium oxidation)
Version / remarks:
1995
GLP compliance:
yes
Specific details on test material used for the study:
Batch no: QA204979
297 mg active ingredient/g purity 98.62%
Vehicle:
no
Details on test solutions:
A stock solution of MI3 was prepared by weighing out 1,1764 g and adding deionised water up to 1000 mL.
Test organisms (species):
activated sludge of a predominantly domestic sewage
Details on inoculum:
Activated sludge collected from Nivå wastewater treatment plant, Denmark. This plant primarily receives domestic wastewater.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
3 h
Remarks on exposure duration:
Recording was made after 30 minutes and 3 hours
Post exposure observation period:
not included
Hardness:
na
Test temperature:
18.9-21.7°C
pH:
test mixtures: 7.5-8 (at the end of the test)
Salinity:
na
Conductivity:
na
Nominal and measured concentrations:
Test substance: 20; 50; 100; 200; 500 mg/L
Reference substance (3,5 dichlorphenol):1; 5; 25; 50; 100 mg/L
Reference substance (positive control):
yes
Remarks:
3,5-dichlorphenol
Key result
Duration:
30 min
Dose descriptor:
EC10
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Key result
Duration:
180 min
Dose descriptor:
EC10
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Key result
Duration:
30 min
Dose descriptor:
EC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Key result
Duration:
180 min
Dose descriptor:
EC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Details on results:
Test substance:
No inhibition was observed at the tested concentrations. The study indicated an EC50 value of > 500 mg/L.
Results with reference substance (positive control):
EC10 (30min) <1 mg/L
EC10 (180min) = 5 (2-9) mg/L
EC50 (30min) <1 mg/L
EC50 (180min) = 5 (3-10) mg/L
EC50 values obtained in ring tests referred to in EN ISO standard are 5-30 mg/L

Oxygen respiration rate of individual test mixtures was calculated applying linear regression.

EC-values for the reference substance were calculated applying the computer programme Toxedo

Validity criteria fulfilled:
yes
Conclusions:
A study was conducted according to the OECD Guideline No 209: Activated sludge respiration inhibition test and EN ISO International standard 8192.
No inhibition was observed at the tested concentrations.
The study indicated that the resulting EC50 value of MI3 is > 500 mg/L after 30 minutes and after 180 minutes.
Executive summary:

A study was conducted according to the OECD Guideline No 209: Activated sludge respiration inhibition test and following EN ISO International standard 8192. No inhibition of respiration was observed at the tested concentrations.

The study indicated that the resulting EC50 value of MI3 after 30 minutes and 180 minutes is > 500 mg/L.

For the reference substance 3,5 dichlorphenol, EC10 and EC 50 were <1 mg/L (30 min) and 5 (3 -10) mg/L (180 min), respectively. EC50 values obtained in ring tests for the reference substance and referred to in EN ISO standard are 5-30 mg/L.

Description of key information

The microbial inhibition of Insulin Human Methyl Ester is assumed to be comparable to that of the source substance S2 (MI3) because of the high degree of structural similarity:

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

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

The resulting EC50 values after 30 minutes and 180 minutes in the microbial inhibition study with the source substance S2 (MI3) were > 500 mg/L. Insulin Human Methyl Ester is predicted to have a toxicity to microorganisms with EC50 > 500 mg/L based on the results in the study with the source substance S2.

Key value for chemical safety assessment

EC50 for microorganisms:
500 mg/L
EC10 or NOEC for microorganisms:
500 mg/L

Additional information