Registration Dossier

Diss Factsheets

Physical & Chemical properties

Water solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
water solubility
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
Water solubility:
ca. 395 mg/L
Remarks on result:
other: soluble in water
Remarks:
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are soluble in water.
Conclusions:
A collection of the water solubility values is available for category members. Considering these values registered substance is considered soluble in water.
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.

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-09-21 to 2010-03-18
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
For the preliminary test at pH 4, 6 and 7, 1g of the test item was weighed instead of 0.1g.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
For the preliminary test at pH 4, 6 and 7, 1g of the test item was weighed instead of 0.1g.
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
Test item code: LCE08116
Name PROTEOLAPL Batch no. 824800002
Appearance Iimpid liquid
Composition sodium cocoyl apple amino acids
CAS No. unknown EINECS-No. unknown
Molecular formula unknown
Molecularweight 381 g/mol, based on disodium cocoyl glutamate
Purity not stated
Homogeneity not stated
Vapour pressure not stated
Stability unknown
Solubility water> 1 g/L
Solubility in ethanol , acetone, DM50, CH3CN unknown
Production date 04. September 2008
Expiry date 04. September 2011
Storage room temperature 20 ± 5°C, dark
Key result
Water solubility:
ca. 395 g/L
Temp.:
25 °C
pH:
6.2
Details on results:
The pH of the solution has no significant effect on the solubility.
The test item contains 30.3% of dry material, the solubility of the test item, based on the dry material content is: 120 g (dry material)/L in deionized water (pH 6.2) at 25°C.
Conclusions:
Interpretation of results: moderately soluble (100-1000 mg/L)
The solubility of the PROTEOL APL is: 395 g/L in deionized water (pH 6.2) at 25°C.
Executive summary:

The solubility of the substance Sodium cocoyl apple amino acids [Na Cocoyl Apple AA] is: 395g/L in deionized water (pH 6.2) at 25°C.

Endpoint:
water solubility
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Find below the water solubility results obtained for two similar products (a comparable value is expected):
- water solubility of acylation product between lauroyl chloride and amino acids (EC: 500-500-3): The solubility of the test item in water is: 278 g/L in deionized water (pH= 6.2) at 25°C

The test item contains 30.3% of dry material, the solubility of the test item, based on the dry material content is: 79 g (dry matter)/L in deionized water (pH= 6.2) at 25°C

- water solubility of acylation product between cocoyl chloride and amino acids (EC: 918-984-3): The solubility of the test item in water is: 395 g/L in deionized water (pH= 6.2) at 25°C
The test item contains 30.3 % of dry material, the solubility of the test item, based on the dry material content is: 120 g (dry matter)/L in deionized water (pH= 6.2) at 25°C

Description of key information

Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are soluble in water.

Key value for chemical safety assessment

Additional information

A collection of the water solubility values are available for category members. All found values are listed below.

EC number

Water solubility

S1 - EC: 918-984-3

moderately soluble

S2 - EC: 927-837-2

moderately soluble (water solubility results obtained for two similar products)

 

Overall, registered substance is considered soluble in water.