Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 August 2017 to 08 Nobember 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
Shake flask
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
MIT.HCl as manufacured has a purity of >99.9% therefore the technical grade and analytical grade are identical
Specific details on test material used for the study:
Batch Number 10013913, Purity >99.9%, Expiry Date 30 November 2018
Analytical grade and technical grade material are identical

Results and discussion

Water solubility
Key result
Water solubility:
ca. 420.3 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
1 429 g/L
Incubation duration:
ca. 72 h
Temp.:
20 °C
pH:
ca. 0

Any other information on results incl. tables

time of shaking

Analyte concentration
Flask 1

Analyte concentration
Flask 2

pH value

[h]

[g/L]

[g/L]

 

24

422.9

420.6

0

48

420.9

416.5

0

72

419.8

420.9

0

Mean:

421.2

419.3

0

SD:

1.6

2.5

0

RSD [%]:

0.4

0.6

 

Overall Mean:

420.3

Overall AD:

1.9

Overall RD [%]:

0.5

Applicant's summary and conclusion

Conclusions:
The solubility of 2-Methyl-4-isothiazolin-3-one hydrochloride was determined in ultra-pure water in equilibrium with atmospheric carbon dioxide at a temperature of 20 ± 0.5 °C according to EC method A.6 (Regulation (EC) No 440/2008) and OECD guideline 105. The shake flask method was used, because the solubility determined in the preliminary test was above 10 mg/L.
The results are presented in the following table:

Determined pH 0
Mean solubility [g/L] 420.3

The results indicate the required reproducibility (relative standard deviation below 15 %) and no tendency to increasing values, when the shaking time was prolonged.
Executive summary:

The solubility of 2-Methyl-4-isothiazolin-3-one hydrochloride was determined in ultra-pure water in equilibrium with atmospheric carbon dioxide at a temperature of 20 ± 0.5 °C according to EC method A.6 (Regulation (EC) No 440/2008) and OECD guideline 105. The shake flask method was used, because the solubility determined in the preliminary test was above 10 mg/L.

The results are presented in the following table:

Determined pH               0

Mean solubility [g/L]       420.3

The results indicate the required reproducibility (relative standard deviation below 15 %) and no tendency to increasing values, when the shaking time was prolonged.