1,3,5-Triazine-2,4-diamine, N2-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)

Qualifier:

according to guideline

Guideline:

EPA Guideline Subdivision N 161-1 (Hydrolysis)

Qualifier:

according to guideline

Guideline:

other: Canada PMRA DACO Number 8.2.3.2

Qualifier:

according to guideline

Guideline:

other: Japan MAFF New Test Guideline, 12 Nousan 8147

GLP compliance:

yes (incl. QA statement)

Radiolabelling:

yes

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent/transformation products: 0 h, 2.5 h, 6 h and 24 h, as well as 2, 5 and 7 days after treatment.
- Sampling method: Two replicates were removed from the water bath at each interval for each pH.
- Sampling methods for the volatile compounds, if any: No attempt was made to collect volatiles.
- Sampling intervals/times for pH measurements: 0 h, 2.5 h, 6 h and 24 h, as well as 2, 5 and 7 days after treatment.
- Sampling intervals/times for sterility check: 0 h and 7 days after treatment.
- Sample storage conditions before analysis: Generally analysis was performed on the day of sampling.

Buffers:

- pH: 4, 7, 9
- Type and final molarity of buffer: For pH 4: 0.01 M sodium acetate/acetic acid solution; for pH 7: 0.01 M tris(hydroxymethyl)aminomethane/HCl solution; for pH 9: 0.01 M boric acid/NaOH solution

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 10 mL glass crimp-top vials closed using crimp caps with Teflon-faced septa. The vials were kept in a temperature-controlled (50°C), covered water bath.
- Sterilisation method: Steam pressure sterilization
- Lighting: Dark conditions
- Is there any indication of the test material adsorbing to the walls of the test apparatus? None

TEST MEDIUM
- Volume used/treatment: 5 mL
- Kind and purity of water: Milli-Q
- Preparation of test medium: The radiolabelled test item was applied to sterile aqueous buffers. The vials were filled with 5 mL buffer solution ( = buffer plus application solution) and were closed in 10 mL crimp top vials under sterile conditions (cleaning-bench).
- Identity and concentration of co-solvent: Acetonitrile, 0.1%
OTHER TEST CONDITIONS
- Test item concentration: 1 mL
- pH: The pH of the test solutions were constant to the setup values within <= 0.1 pH units during the test.

Duration:

7 d

Temp.:

50 °C

Initial conc. measured:

1 mg/L

Number of replicates:

2

Statistical methods:

Arithmetic means were used in case of all LS measurements.
No rejection criteria were used.

Preliminary study:

The above described method applies to the preliminary study. As no hydrolytic degradation occurred at 50°C in this preliminary study, the tests with the second label and at 25°C and 20°C have been omitted. The test substance is hydrolytically stable under acidic, neutral and alkaline conditions at 50°C. According to the OECD Test Guideline 111, the DT50 is > 1 year at 25°C.

Transformation products:

no

pH:

4

Temp.:

25 °C

DT50:

> 1 yr

Remarks on result:

other: As no hydrolytic degradation was observed after 7 days, the DT50 is > 1 year according to OECD 111.

pH:

7

Temp.:

25 °C

DT50:

> 1 yr

Remarks on result:

other: As no hydrolytic degradation was observed after 7 days, the DT50 is > 1 year according to OECD 111.

pH:

9

Temp.:

25 °C

DT50:

> 1 yr

Remarks on result:

other: As no hydrolytic degradation was observed after 7 days, the DT50 is > 1 year according to OECD 111.

Details on results:

As no hydrolytic degradation occurred at 50°C in this preliminary study, the tests with the second label and at 25°C and 20°C have been omitted. The test substance is hydrolytically stable under acidic, neutral and alkaline conditions at 50°C. According to the OECD Test Guideline 111, the DT50 is > 1 year at 25°C.

The total radiocarbon recovery ranged from 92.8% to 107.5% of the applied amount. The complete material balances found in all solutions demonstrated that no RA dissipated from the solutions by means of volatilization or was lost during sampling/processing.

Description of key information

The substance is hydrolytically stable under environmental conditions (25 °C, pH 7) (DT50 > 1 year).

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

25 °C

Additional information

One GLP guideline study on the hydrolytic degradation according to OECD Guideline 111 is available (Sneikus, 2007).

As no significant hydrolytic degradation occurred at 50°C in the preliminary study in sterile buffered solutions at pH 4, 7 and 9 during 7 days, the main test at 25°C and the test at 20°C have been omitted. The test substance is hydrolytically stable under acidic, neutral and alkaline conditions at 50°C. According to the OECD Test Guideline 111, the DT50 is > 1 year at 25°C. No transformation products were identified.