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Physical & Chemical properties

Boiling point

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Endpoint:
boiling 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
Boiling pt.:
> 100 °C
Decomposition:
no
Remarks on result:
other: Boiling point values are available for category members: (i) 105°C, (ii) 106.5°C.
Remarks:
Boiling point values are available for category members: (i) 105°C, (ii) 106.5°C.
Conclusions:
A collection of the boiling point values is available for category members. Considering these values the registered substance has a boiling point higher than 100°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.

Endpoint:
boiling point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Dec. 2007 - 20 Feb. 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD n° 103 and GLP study
Qualifier:
according to guideline
Guideline:
OECD Guideline 103 (Boiling Point)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.2 (Boiling Temperature)
Deviations:
no
Principles of method if other than guideline:
The test item sample and reference material are both maintained at the temperature predetermined by the program even during a thermal event in the sample. The amount of energy which has to be supplied to the sample to maintain zero temperature differential between the test item sample and the reference material is the experimental parameter displayed as the ordinate of the thermal analysis curve. The rate of energy absorption by the sample is proportional to the specific heat of the sample.
Any transition accompanied by a change in specific heat produces a discontinuity in the power signal. Boiling of the test item will be characterized by an endothermic enthalpy change that gives a peak whose area is proportional to the total enthalpy change. The boiling temperature depends on the atmospheric pressure so boiling temperature will be corrected if necessary.
GLP compliance:
yes (incl. QA statement)
Type of method:
differential scanning calorimetry
Specific details on test material used for the study:
TEST ITEM
Identification LCE07102
Identification of the flask LCE07102, Req Nr: 24/07/00262/05,
Net: 2,500 L
Batch LCE07102
Expiry date Not provided
Supplier SEPPIC
Appearance Yellow liquid
Packaging 2 White opaque plastic flasks
Quantity received 2 x 1 Kg
Date of the reception December 12, 2007
Storage In darkness at room temperature
Identification number for the study 07-157
REFERENCE ITEM
Identification 1,2 Propanediol 99%
Supplier ACROS
Batch A0249565
Expiry date of the reference item December 03, 2008
Last validation of the test December 05, 2007
Periodicity of validation (in months) 12
Results 187.0 ± 0.5 °C
Conformity Yes

Apparatus
Analyser DSC 131 The analyzer is connected to a computer using the Setsoft 2000 program
Balance
Barometer
Key result
Boiling pt.:
ca. 106.5 °C
Atm. press.:
>= 98.3 - <= 98.7 kPa
Decomposition:
no
Conclusions:
The boiling point was calculated: 106.5 +/- 0.5 °C at 98.5 +/- 0.2 kPa.
Executive summary:

BOILING POINT (DSC METHOD)

In compliance with Commission Directive 92/69/EEC A2 method (1992) and OECD Guideline No. 103 (1995)

AMENDMENTS

No amendment to the study plan was requested.

DEVIATIONS

No incident, which could have affected the quality or the interpretation of the results obtained, was observed.

RESULTS

The mean corrected boiling point of the test item was: 106.5 ± 0.5 °C.

Endpoint:
boiling 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: experimental study which follows standard guidelines
Qualifier:
according to guideline
Guideline:
OECD Guideline 103 (Boiling point/boiling range)
GLP compliance:
no
Type of method:
differential scanning calorimetry
Specific details on test material used for the study:
Name of the test material (as cited in the study report): PROTEOL APL
Lots/batches: LR10709-LR 10747-LR10749
Key result
Boiling pt.:
105 °C
Atm. press.:
1 atm
Decomposition:
no
Conclusions:
The mean boiling point of the test item was (on 2 assays on 3 batches): 105°C (+/- 2°C)
Executive summary:

The mean boiling point of the test item was (on 2 assays on 3 batches): 105°C (+/- 2°C)

Description of key information

Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) have boiling point values higher than 100°C.

Key value for chemical safety assessment

Additional information

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

EC number

Boiling point (°C)

S1 - EC: 918-984-3

105°C

S2 - EC: 927-837-2

106.5°C

Overall, registered substance has boiling point higher than 100°C.