thermomycolin

Water solubility

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Principles of method if other than guideline:

A purified, lyophilized Subtilisin Carlsberg (Sigma) was dissolved at 25°C in dest. water up to the dissolving limit (formation of sediment at the bottom of the test tube). An appropriate amount of liquid was transferred to a weighted test tube, frozen and lyophilized. The remaining protein content was measured gravimetrically.

GLP compliance:

no

Type of method:

other: gravimetrically measurement

Water solubility:

> 100 g/L

Temp.:

25 °C

pH:

7.8

Remarks on result:

other: Note: Data was published in HERA 2007 as “> 1 kg/L”, but has to be corrected to “> 100 g/L”.

Details on results:

For this sample a water solubility of 280 to 290 g/L was found.

Conclusions:

Interpretation of results: very soluble (> 10000 mg/L)
The water solubility of the test substance is above 100 g/L thus the test substance is very soluble in water.

Reference 2

Endpoint:

water solubility

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

GLP compliance:

no

Water solubility:

> 100 g/L

Temp.:

25 °C

pH:

7.8

Remarks on result:

other: Source: CAS 9014-01-1, HERA, 2007, RL1

Conclusions:

Interpretation of results: very soluble (> 10000 mg/L)
The water solubility of Thermomycolin is above 100 g/L and therefore it is very soluble in water.

Executive summary:

Result of water solubility for source substance, Subtilisin, CAS 9014 -01 -1: Very soluble (> 10000 mg/L).

Thermomycolin shares the same structural features as Subtilisin as explained in the Analogue Approach Justification document provided in Section 13. Thus, based on the read-across from the structural analogue substance Subtilisin (CAS 9014-01-0), the target substance Thermomycolin (CAS 52233-31-5) is considered to possess the water solubility as the source.

Description of key information

The water solubility of the test substance is above 100 g/L and thus the substance is very soluble in water.