L-Glutamic acid, N-coco acyl derivs., monosodium salts

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

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 data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

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 hydrolysis studies as-
WoE 2. and WoE 3.

GLP compliance:

not specified

Radiolabelling:

not specified

Analytical monitoring:

yes

Remarks:

WoE 2: yes and WoE 3: no data available

Duration:

28 d

Remarks:

WoE 3: Other details not known

Remarks:

WoE 2: Details not known

Positive controls:

not specified

Negative controls:

not specified

Transformation products:

not specified

Key result

DT50:

> 96 h

Remarks on result:

other: WoE 2: Test chemical was reported to be stable in water.

Key result

DT50:

> 28 d

Remarks on result:

other: WoE 3: Hydrolysis of test chemical was not observed in a 28 days test period.

Details on results:

WoE 2: The precision and variation of reananlyzed 100 microgarm/ml of test solutions for confirmation stability were within 0.60% and -9.49% of the original concentrations following storage in maintenance water for 96 hours. Also, the precision and variation of reananlyzed 1100 microgarm/mL test solutions for confirmation stability were within 6.99-1.05% and -1.05 to -1.68% of the original concentrations following storage in OECD medium for 72 hours.
WoE 3: Hydrolysis of test chemical was not observed in a 28 days test period.

Validity criteria fulfilled:

not specified

Conclusions:

On the basis of the experimental study results of the test chemical and applying the weight of evidence approach, test chemical was considered to be stable in water.

Executive summary:

Data available for its read across chemicals has been reviewed to determine the hydrolysis half-life of the test chemical in water. The studies are as mentioned below:

The half-life of the test chemical was determined. Test chemical concentrations were analyzed using HPLC. Duplicate samples from the mid-layer of each batch were analyzed every 24 hours for stability. The 0 hours samples were also used to determine intra-day variation. The results were considered to be acceptable when the precision was within 10% and the variation of stability was +/-20% of the original concentration. The analyses of maintenance water and OECD medium were conducted until 96 and 72 hours, respectively. The precision and variation of reananlyzed 100 microgarm/ml of test solutions for confirmation stability were within 0.60% and -9.49% of the original concentrations following storage in maintenance water for 96 hours. On the other hand, the precision and variation of reananlyzed 1100 microgarm/ml test solutions for confirmation stability were within 6.99-1.05% and -1.05 to -1.68% of the original concentrations following storage in OECD medium for 72 hours. Thus, the half-life value of test chemical in water was evaluated to be >96 hrs, indicating that the test chemical was considered to be hydrolytically stable in water.

In an another study, the half-life of the test chemical was determined. Test chemical does not undergo hydrolysis in a 28 day study. Thus, half-life of test chemical was evaluated to be >28 days, indicating that the test chemical is stable in water.

On the basis of the experimental study results of the test chemical and applying the weight of evidence approach, test chemical was considered to be hydrolytically stable.

Description of key information

On the basis of the experimental study results of the test chemical and applying the weight of evidence approach, test chemical was considered to be stable in water.

Additional information

Data available for its read across chemicals has been reviewed to determine the hydrolysis half-life of the test chemical in water. The studies are as mentioned below:

 

The half-life of the test chemical was determined. Test chemical concentrations were analyzed using HPLC. Duplicate samples from the mid-layer of each batch were analyzed every 24 hours for stability. The 0 hours samples were also used to determine intra-day variation. The results were considered to be acceptable when the precision was within 10% and the variation of stability was +/-20% of the original concentration. The analyses of maintenance water and OECD medium were conducted until 96 and 72 hours, respectively. The precision and variation of reananlyzed 100 microgarm/ml of test solutions for confirmation stability were within 0.60% and -9.49% of the original concentrations following storage in maintenance water for 96 hours. On the other hand, the precision and variation of reananlyzed 1100 microgarm/ml test solutions for confirmation stability were within 6.99-1.05% and -1.05 to -1.68% of the original concentrations following storage in OECD medium for 72 hours. Thus, the half-life value of test chemical in water was evaluated to be >96 hrs, indicating that the test chemical was considered to be hydrolytically stable in water.

 

In an another study, the half-life of the test chemical was determined. Test chemical does not undergo hydrolysis in a 28 day study. Thus, half-life of test chemical was evaluated to be >28 days, indicating that the test chemical is stable in water.

 

On the basis of the experimental study results of the test chemical and applying the weight of evidence approach, test chemical was considered to be hydrolytically stable.