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Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 January 2009 to 26 February 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 19 August 2008; Date of signature: 04 March 2009

Test material

Constituent 1
Details on test material:
Sponsor's identification : H-MI ammonium salt
Description : dark red solid
Batch number : MB-1
Date received : 04 December 2008
Storage conditions : room temperature in the dark

Radiolabelling:
no

Study design

Analytical monitoring:
yes
Duration of testopen allclose all
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
0.515 g/L
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
0.514 g/L
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
0.511 g/L
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
0.513 g/L
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
0.502 g/L
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
0.501 g/L

Results and discussion

Transformation products:
not specified
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
pH:
9
Temp.:
25 °C
DT50:
> 1 yr

Any other information on results incl. tables

Preliminary test/Tier 1

The mean peak areas relating to the standard and sample solutions are shown in the following table:

Table 2

Solution

Mean peak area

Standard 487 mg/l

1.237 x 104

Standard 505 mg/l

1.291 x 104

Initial Sample A, pH 4

1.316 x 104

Initial Sample B, pH 4

1.317 x 104

Standard 563 mg/l

1.420 x 104

Standard 530 mg/l

1.341 x 104

69 Hour Sample A, pH 4

1.309 x 104

69 Hour Sample B, pH 4

1.309 x 104

Standard 568 mg/l

1.436 x 104

Standard 560 mg/l

1.436 x 104

120 Hour Sample A, pH 4

1.312 x 104

120 Hour Sample B, pH 4

1.308 x 104

Standard 578 mg/l

1.490 x 104

Standard 551 mg/l

1.420 x 104

Initial Sample A, pH 7

1.315 x 104

Initial Sample B, pH 7

1.319 x 104

Standard 493 mg/l

1.308 x 104

Standard 513 mg/l

1.331 x 104

69 Hour Sample A, pH 7

1.303 x 104

69 Hour Sample B, pH 7

1.299 x 104

Standard 554 mg/l

1.403 x 104

Standard 551 mg/l

1.419 x 104

120 Hour Sample A, pH 7

1.306 x 104

120 Hour Sample B, pH 7

1.310 x 104


Solution

Mean peak area

Standard 538 mg/l

1.377 x 104

Standard 542 mg/l

1.387 x 104

Initial Sample A, pH 9

1.361 x 104

Initial Sample B, pH 9

1.365 x 104

Standard 516 mg/l

1.261 x 104

Standard 524 mg/l

1.315 x 104

69 Hour Sample A, pH 9

1.284 x 104

69 Hour Sample B, pH 9

1.292 x 104

Standard 553 mg/l

1.417 x 104

Standard 532 mg/l

1.375 x 104

120 Hour Sample A, pH 9

1.291 x 104

120 Hour Sample B, pH 9

1.291 x 104


The test material concentrations at the given time points are shown in the following tables:

Table 3    pH 4 at 50.0 ± 0.5ºC

Time (Hours)

Concentration (g/l)

Log10[concentration (g/l)]

% of mean initial concentration

A

B

A

B

A

B

0

0.517

0.517

-0.287

-0.286

99.9

100

69

0.518

0.518

-0.285

-0.285

100

100

120

0.515

0.514

-0.288

-0.289

99.7

99.4

Result:           Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.

Table 4    pH 7 at 50.0 ± 0.5ºC

Time (Hours)

Concentration (g/l)

Log10[concentration (g/l)]

% of mean initial concentration

A

B

A

B

A

B

0

0.510

0.512

-0.292

-0.291

99.9

100

69

0.497

0.495

-0.304

-0.305

97.2

96.9

120

0.511

0.513

-0.291

-0.290

100

100

Result:           Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.

Table 5    pH 9 at 50.0 ± 0.5ºC

Time (Hours)

Concentration (g/l)

Log10[concentration (g/l)]

% of mean initial concentration

A

B

A

B

A

B

0

0.532

0.533

-0.274

-0.273

99.8

100

69

0.518

0.522

-0.285

-0.283

97.4

98.0

120

0.502

0.501

-0.300

-0.300

94.3

94.2

Result:           Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.


 Validation

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 1.00 x 103 mg/l for each matrix. These were satisfactory with correlation coefficients of ≥ 0.999 being obtained.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The estimated half-lives at 25°C of the test material at pH 4, pH7 and pH9 was shown to be >1 year.
Executive summary:

Assessment of hydrolytic stability was carried out using Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008.

The results are as follows:

pH

Estimated half-life at 25°C

4

>1 year

7

>1 year

9

>1 year

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