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Environmental fate & pathways

Hydrolysis

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Administrative data

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Reference
Endpoint:
hydrolysis
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 07 June, 1996 to 19 July, 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Refer to the section 13 of IUCLID dataset for details on the read across justification. The algae study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
Cited as Directive 84/449/EEC, C.10
GLP compliance:
yes (incl. QA statement)
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
At each sampling time 750 µL of sample was taken and added to 750 µL mobile phase. The samples were stored in the freezer until analyses. The temperature of the thermostatic water bath was checked at least at the start and end of the tests and at each sampling time.
Buffers:
pH=4: 100 mL of 0.5 M potassium hydrogen phtalate and 0.8 mL 0.5 M NaOH made up to 1 L with deionized water
pH=7: 100 mL of 0.5 M potassium hydrogen phosphate and 5.92 mL 5 M NaOH made up to 1 L with deionized water
pH=9: 100 mL of 0.5 M boric acid, 100 mL of 0.5 M potassium chloride and 100 mL 4.32 M NaOH made up to 1 L with deionized water
Details on test conditions:
Glassware: Air-tight glass vessels
Other equipment: Thermostatic water bath, thermometer, pH meter.
Method of sterilization: All glassware and buffers were sterilized by autoclaving.
Duration:
8 350 min
pH:
4
Temp.:
20 °C
Initial conc. measured:
ca. 4.606 mg/L
Duration:
8 350 min
pH:
7
Temp.:
20 °C
Initial conc. measured:
ca. 5.455 mg/L
Duration:
8 350 min
pH:
9
Temp.:
20 °C
Initial conc. measured:
ca. 2.948 mg/L
Number of replicates:
2
Transformation products:
not specified
Key result
pH:
4
Temp.:
20 °C
DT50:
>= 1 yr
Key result
pH:
7
Temp.:
20 °C
DT50:
>= 1 yr
Key result
pH:
9
Temp.:
20 °C
DT50:
>= 1 yr
Details on results:
- After 5 days at 50°C, less than 10% decrease in the test substance concentration was measured at all three pH values. It was therefore concluded that test substance was hydrolytically stable with a half-life equal to or greater than one year at pH 4, 7 and 9 at ambient temperatures. A minor decrease of test substance at all three tested pH values was observed, which was probably due to inaccuracies of the test method and/or the analytical method.
- The results of this study with C12-16 chains of the test substance were representative for the whole range of products. All substances have the same molecular structure, similar very high solubility and are completely discosiated in water (in cationic form). All products are only on the market as solutions in water, and are known to be stable for many years.
Validity criteria fulfilled:
yes
Conclusions:
Based on the results of the read across study, the test substance is considered to be hydrolytically stable with a half-life equal to or greater than one year at pH 4, 7 and 9 at ambient temperature.
Executive summary:

A study was conducted to determine the hydrolysis of the read across substance, C12 -16 ADBAC (active: 50.2%), according to EU Method C.7, in compliance with GLP. The hydrolytic stability was investigated in buffer solutions of pH 4, 7 and 9 in a water bath at 50ºC for 5 days. Samples were taken at t0 and at regular intervals afterwards to determine half-life time (t½). If t½ is less than 2.4 h, or if less than 10% of the test substance is hydrolysed in 5 d, no further tests need to be performed at that pH. After 5 d at 50°C, less than 10% decrease in test substance concentration was measured at all three pH values. Under the conditions of the study, the read across substance was concluded to be hydrolytically stable with a half-life equal to or greater than one year at pH 4, 7 and 9 at ambient temperature (Geurts, 1996). Based on the results of the read across study, similar behaviour is expected for the test substance, C18 ADBAC.

Description of key information

Based on the results of the read across study, the test substance, C18 ADBAC, is considered to be hydrolytically stable.

Key value for chemical safety assessment

Additional information

A study was conducted to determine the hydrolysis of the read across substance, C12 -16 ADBAC (active: 50.2%), according to EU Method C.7, in compliance with GLP. The hydrolytic stability was investigated in buffer solutions of pH 4, 7 and 9 in a water bath at 50ºC for 5 days. Samples were taken at t0 and at regular intervals afterwards to determine half-life time (t½). If t½ is less than 2.4 h, or if less than 10% of the test substance is hydrolysed in 5 d, no further tests need to be performed at that pH. After 5 d at 50°C, less than 10% decrease in test substance concentration was measured at all three pH values. Under the conditions of the study, the read across substance was concluded to be hydrolytically stable with a half-life equal to or greater than one year at pH 4, 7 and 9 at ambient temperature (Geurts, 1996). Based on the results of the read across study, similar behaviour is expected for the test substance, C18 ADBAC.