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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Toxicity to microorganisms

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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
Justification for type of information:
Data for the target chemical is summarized data from handbook or collection of data
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two toxicity study of microorganism for the test chemical :
1.Immobilization of Candida rugosa lipase on bentonite was observed which is modified with test chemical.
2.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.
GLP compliance:
not specified
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
1.PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Chemical name of vehicle (organic solvent, emulsifier or dispersant):sodium bentonite-Modification of the bentonite clay was carried out via the exchange of the quaternary ammonium cations of the benzyltriethylammonium ion (BTEA+).
Test organisms (species):
other: 1) Candida sps. 2) Vibrio fisheri
Details on inoculum:
1.Candida rugosa lipase (CRL)- Initial biomass concentration:≥700 units/mg solid
Test type:
static
Water media type:
freshwater
Total exposure duration:
15 min
Test temperature:
35-45 degrees C
pH:
5.5-7.0
Details on test conditions:
1) For the synthesis of the benzyltriethylammonium chloride (BTEAC)organoclay, two concentrations of the quaternary ammonium salt were used, 1.0 and 2.1 equivalents of the CEC of the Na-Bent. Sodium bentonite in water (2%, w/v) was mixed with a BTEAC solution until a clay-solution ratio of 1:100 g/mL was obtained.
Dose descriptor:
EC50
Effect conc.:
>= 117.8 - <= 511.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Remarks on result:
other: Immobilization effects showed by modified clay of benzyltriethylammonium chloride using 1.0 and 2.1 times the cation exchange capacity (CEC) of the clay.
Key result
Duration:
15 min
Dose descriptor:
EC50
Effect conc.:
284 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Remarks on result:
other: Other details not known
Validity criteria fulfilled:
not specified
Conclusions:
The test chemica is not likely to be toxic to microorganism atleast in the dose range of 100-405.0 mg/l
Executive summary:

Data available for the functionally similar read across chemicals has been reviewed to determine the short term toxicity of microorganism of the test chemical .The studies are as mentioned below:

In the first study the organobentonites were prepared from sodium bentonite by interchange with test material, using 1.0 and 2.1 times the cation exchange capacity (CEC) of the clay. The enzymatic activities of the lipase immobilized in the two organobentonites were 511.5 and 177.8 U/g support, while the activity recoveries were 33.5% and 14.7%. C. rugosa lipase immobilized on BTEA-1.0-Bent was found to be the optimal system studied, and it showed the greatest activity recovery with respect to the hydrolysis of olive oil (33.5%). This result is due to the smaller charge compensated by the organic cations, allowing for the dispersion of the lipase on the support, preventing its aggregation and maintaining its activity. However, the CRL/BTEA-2.1-Bent system showed a higher thermal stability between the range of 35 and 45 ◦C and pH 6.5.

Above data is supported by the another data from journal. 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).

Hence,based on the data available for the functionally similar read across, test chemical is not likely to be toxic atleast in the dose range of 511 mg/L.

Description of key information

The test chemica is not likely to be toxic to microorganism atleast in the dose range of 100-405.0 mg/l

Key value for chemical safety assessment

EC50 for microorganisms:
284 mg/L

Additional information

Data available for the functionally similar read across chemicals has been reviewed to determine the short term toxicity of microorganism of the test chemical .The studies are as mentioned below:

 

In the first study the organobentonites were prepared from sodium bentonite by interchange with test material, using 1.0 and 2.1 times the cation exchange capacity (CEC) of the clay. The enzymatic activities of the lipase immobilized in the two organobentonites were 511.5 and 177.8 U/g support, while the activity recoveries were 33.5% and 14.7%. C. rugosa lipase immobilized on BTEA-1.0-Bent was found to be the optimal system studied, and it showed the greatest activity recovery with respect to the hydrolysis of olive oil (33.5%). This result is due to the smaller charge compensated by the organic cations, allowing for the dispersion of the lipase on the support, preventing its aggregation and maintaining its activity. However, the CRL/BTEA-2.1-Bent system showed a higher thermal stability between the range of 35 and 45 ◦C and pH 6.5.

 

Above data is supported by another data from journal. 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).

 

Hence, based on the data available for the functionally similar read across, test chemical is not likely to be toxic at least in the dose range of 511 mg/L.