Registration Dossier

Ecotoxicological information

Toxicity to microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to microorganisms, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Experimental results of read across chemicals
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
WoE report is prepared based on the toxicity to microorganisms studies including WoE 2 and 3.
GLP compliance:
not specified
Analytical monitoring:
yes
Vehicle:
not specified
Test organisms (species):
other: 1. Vibrio fisheri and 2. Pseudomonas putida
Test type:
static
Water media type:
freshwater
Total exposure duration:
17 h
Post exposure observation period:
1. 15 min
Test temperature:
2. 20 degrees C
Details on test conditions:
1. TEST SYSTEM- No. of vessels per concentration (replicates):triplicates
Reference substance (positive control):
not specified
Key result
Duration:
15 min
Dose descriptor:
EC50
Effect conc.:
284 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Remarks on result:
other: 1 study
Key result
Duration:
17 h
Dose descriptor:
EC50
Effect conc.:
95 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: cell proliferation inhibition
Remarks on result:
other: 2nd study
Details on results:
1. Results of the Student–Newman–Keuls post-hoc statistical test for pairwise comparison of EC50 (mmol L/1).
Reported statistics and error estimates:
1. The differences tested by ANOVA are highly significant (P o 0.001), moreover, the post-hoc test.
Validity criteria fulfilled:
not specified
Conclusions:
1. Vibrio fischeri in a 15 min inhibition of bioluminescence test the 50% effect concentrations (EC50) of the test chemical was observed to be 284 mg/l with 95% confidence limit (241–336).2. Based on the cell proliferation inhibition of aquatic Pseudomonas putida (Bacteria) by the chemical exposure for 17 hrs, the EC50 was determine at 95 mg/l.Thus based on the overall studies for the test material, it was concluded that chemical was nontoxic as value ranges from 95 -284 mg/l.
Executive summary:

Toxicity of test chemical on the growth and cell proliferation of aquatic microorganisms is predicted on the basis of it structurally and functionally similar read across chemicals. The studies are as mentioned below:

In the first study, toxicity to V. fischeri was measured as inhibition of bioluminescence using Microtoxs M500 Rapid Toxicity Testing System equipment and consumables.The assay was carried out in accordance with the 90% basic test for pure compounds protocol, as described in the Microtox user’s manual. The EC50 values of the tested chemical for V. fischeri range from 1.3 to 284 mg L1. The differences tested by ANOVA are highly significant (P o 0.001). In experiment the 50% effect concentrations (EC50) of the test chemical to Vibrio fischeri in a 15 min inhibition of bioluminescence test was observed to be 284 mg/l with 95% confidence limit (241–336).

Similarly in 2nd study was conducted to determine the effect of test chemical on the growth of Pseudomonas putida. Study conducted for 17 hrs. Based on the cell proliferation inhibition of aquatic Pseudomonas putida (Bacteria) by the chemical exposure for 17 hrs, the EC50 was determine at 95 mg/l. Thus based on the observed effect chemicla was not consider as toxic.

Thus based on the overall studies for the test material, it was concluded that chemical was nontoxic as value ranges from 95 -284 mg/l.

Description of key information

1. Vibrio fischeri in a 15 min inhibition of bioluminescence test the 50% effect concentrations (EC50) of the test chemical was observed to be 284 mg/l with 95% confidence limit (241–336 mg/l).

2. Based on the cell proliferation inhibition of aquatic Pseudomonas putida (Bacteria) by the chemical exposure for 17 hrs, the EC50 was determine at 95 mg/l.

Thus based on the overall studies for the test material, it was concluded that chemical was nontoxic as value ranges from 95 -284 mg/l.

Key value for chemical safety assessment

EC50 for microorganisms:
284 mg/L

Additional information

Toxicity of test chemical on the growth and cell proliferation of aquatic microorganisms is predicted on the basis of it structurally and functionally similar read across chemicals. The studies are as mentioned below:

In the first study, toxicity to V. fischeri was measured as inhibition of bioluminescence using Microtoxs M500 Rapid Toxicity Testing System equipment and consumables.The assay was carried out in accordance with the 90% basic test for pure compounds protocol, as described in the Microtox user’s manual. The EC50 values of the tested chemical for V. fischeri range from 1.3 to 284 mg L1. The differences tested by ANOVA are highly significant (P o 0.001). In experiment the 50% effect concentrations (EC50) of the test chemical to Vibrio fischeri in a 15 min inhibition of bioluminescence test was observed to be 284 mg/l with 95% confidence limit (241–336).

Similarly in 2nd study was conducted to determine the effect of test chemical on the growth of Pseudomonas putida. Study conducted for 17 hrs. Based on the cell proliferation inhibition of aquatic Pseudomonas putida (Bacteria) by the chemical exposure for 17 hrs, the EC50 was determine at 95 mg/l. Thus based on the observed effect chemicla was not consider as toxic.Thus based on the overall studies for the test material, it was concluded that chemical was nontoxic as value ranges from 95 -284 mg/l.