Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 September 1996 - 17 March 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted to GLP 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 the relevant results. The result is a relatively low limit value; ideally the study would have tested at higher concentrations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
Due to the rapid hydrolysis of the test substance in water, the solubility of its hydrolysis product, MMBA (3-methoxy-2-methylbenzoic acid), was determined. Development work showed that the solubility of MMBA (3-methyoxy-2-methylbenzoic acid) increased with the addition of test substance. Therefore the test was performed with the maximum concentration of test substance in water that could be physically stirred.
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid mass
Details on test material:
MMBC
Appearance: light brown solid
Storage conditions: room temperature

Results and discussion

Water solubility
Key result
Water solubility:
> 0.4 g/L
Temp.:
20 °C
pH:
>= -0.77 - <= -0.58
Details on results:
Analytical data is given in Table 1 yielding a range of water solubility results of 0.35050 g/L to 0.43362 g/L (mean 0.40299 g/L). The pH values of the solutions ranged from -0.77 to -0.58.

Quality control data is given in Table 2 showing a recovery of 104.7 % (mean of 105.7 % and 103.6 %).

No peaks were observed at the retention time of the test substance in any of the blank solutions, showing the analytical method was free of interferences.

Any other information on results incl. tables

Table 1 Analytical Data

Test

Integrated Peak Area

Water Solubility (g/L)

Mean Water Solubility for Each Test (g/L)

Overall Mean Solubility (g/L)

pH

1A

1B

 

2A

2B

 

3A

3B

43821824

41388608

 

41747648

35336832

 

42308800

39567616

0.43362

0.40979

 

0.41330

0.35050

 

0.41880

0.39195

0.42170

 

 

0.38190

 

 

0.40537

 

 

 

0.40299

-0.58

-0.73

 

-0.74

-0.71

 

-0.77

-0.77

Blank 1 pH 6.70

Blank 2 pH 7.3

Blank 3 pH 6.91

 

Table 2 Quality Control Data

Quality Control Solution

Integrated Peak Area

Analysed Concentration (µg/mL)

Nominal Concentration (µg/mL)

Recovery (%)

Mean Recovery (%)

1

2

53701120

52629888

1060.8

1039.8

1003.5

1003.5

105.7

103.6

104.7

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
The water solubility of MMBC was determined as MMBA and found to be > 0.40 g/L at 20°C.
Executive summary:

Given the very rapid hydrolysis of MMBC this study has been conducted on the hydrolysis product MMBA. The water solubility of MMBA has been determined to be > 0.40 g/L at 20°C. The test was conducted in accordance with EU Method A.6.