Sodium lauroyl oat aminoacids

Melting point / freezing point

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

melting point/freezing point

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

Find below the freezing points results obtained for two similar products (a comparable value is expected):

- freezing point of acylation product between lauroyl chloride and amino acids / EC: 500-500-3: Freezing temperature is less than -10°C.

- freezing point of acylation product between cocoyl chloride and amino acids / EC: 918-984-3: Freezing temperature is less than -10°C.

Reference 2

Endpoint:

melting point/freezing point

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Justification for type of information:

REPORTING FORMAT FOR THE CATEGORY APPROACH
Registered substance (as identified in Section 1.1 identification) has similar chemical structure as the others members of the Category "Amino Acid Alkyl Amides, Sodium or Potassium Salts" (the source chemicals).

The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” has been developed and evaluated to cover the assessment of the intrinsic properties of several similar substances within the context of REACH Regulation. The Category includes sodium or potassium salts of amino acid alkyl amides, with a carbon chain length range of C6-C16 and an aminoacidic pool of not selected aminoacids reflecting the natural distributions of aminoacids in various vegetables and cereals.


1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The Category has been built up considering the common chemical structure of its members. They are UVCB substances and they share the following features:
- they are salts of amino acid alkyl amides
- they are sodium or potassium salts
- the carbon chain length ranges between C6 and C16
- the carbon chain derives from cocoyl or lauroyl fatty acids
- the aminoacidic part of the molecules comes from a pool of aminoacids
- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.

Overall, the Category was formed on the hypothesis that substances sharing this common chemical structure can be considered analogues and can share intrinsic properties too. No trends in properties is expected, except for those physicochemical properties depending on the carbon chain length.

2. CATEGORY APPROACH JUSTIFICATION
These substances share (i) eye damage and (ii) the absence of significant systemic toxicity.

Key result

Melting / freezing pt.:

< -10 °C

Atm. press.:

ca. 1 atm

Decomposition:

no

Remarks on result:

other:

Remarks:

The batch temperature could not reach - 20°C because of the solvant mixture used: ice, salt and acetone

Conclusions:

A collection of the melting point/freezing point values are available for category members. Considering these values the registered substance has a freezing point < -10 °C.

Executive summary:

The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” was formed on the hypothesis that substances sharing common chemical structure can be considered analogues and can share intrinsic properties too.

Based on this assumption, this property may be assessed using available data for the category members.

The category has been assessed for members characterized by:

- sodium or potassium salts

- the carbon chain length ranges between C6 and C16

- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.

Reference 3

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January-March 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: test performed following pharmacopea method

Qualifier:

according to guideline

Guideline:

other: USP method<651>

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Principles of method if other than guideline:

The product is introduced in a tube, containing a mercury thermometer on a height of 5 to 5.7 cm. Put the tube in a cold bath (mixture of ice, salt and acetone), having a temperature of about -12°C. The product temperature is recorded every 30 seconds until the product is frozen or until the bath temperature is reached (approximately -10°C).

GLP compliance:

no

Type of method:

other: The temperature at which a substance passes from the liquid to the solid state upon cooling is a useful index to purity if heat is liberated when the solidification takes place, provided that any impurities present dissolve in liquid and not in solid

Specific details on test material used for the study:

Name of the test material (as cited in the study report): PROTEOL APL
Lot/batch: LR 10709

Key result

Melting / freezing pt.:

< -10 °C

Atm. press.:

1 atm

Decomposition:

no

Remarks on result:

other: The batch temperature could not reach - 20°C because of the solvant mixture used: ice, salt and acetone

Conclusions:

Freezing temperature of the test item is less than -10°C.

Executive summary:

Freezing temperature of the test item is less than -10°C.

Description of key information

Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) have freezing point < -10 °C.

Additional information

A collection of the melting point/freezing point values is available for category members. All found values are listed below.

EC number	Melting point/Freezing point (°C)
S1 - EC: 918-984-3	< -10 °C
S2 - EC: 927-837-2	< -10 °C

 

Overall, registered substance has a freezing point < -10 °C.