Registration Dossier

Diss Factsheets

Physical & Chemical properties

Density

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Manufacturer's data using standard electric measuring apparatus: 4 place digital density meter for measurement of density.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The density was calculated using the measurement of a known mass of the product and its volume

GLP compliance:
no
Type of method:
other: measurement of density with standard apparatus: 4 place digital density meter
Specific details on test material used for the study:
Name of the test material(as cited in study report):Proteol APL
batches:
0824000008
0824200013
0824200014
Key result
Type:
relative density
Density:
1.111 g/cm³
Temp.:
20 °C
Remarks on result:
other: no guideline was followed
Remarks:
The relative density was calculated using the measurement of a volume related to a known mass -3 batches were used-. The relative density mean value of the three commercial batches tested using an electric measuring apparatus was: stated to 1.111 at 20 °C
Conclusions:
The relative density mean value of the three commercial batches tested using an electric measuring apparatus was: stated to 1.111 at 20 °C
Executive summary:

No guidline was followed

The relative density was calculated using the measurement of a volume related to a known mass

3 Batches were used

The relative density was stated to 1.111

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Manufacturer's data using standard electric measuring apparatus: digital density meter for measurement of density.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The density was calculated using the measurement of a known mass of the product and its volume

GLP compliance:
no
Type of method:
other: measurement of density with standard apparatus: a digital density meter is an instrument that is designed to measure and display in numerical digits the relative density (i.e., mass per mass) of a liquid.
Specific details on test material used for the study:
Name of the test material (as cited in study report): Proteol APL green
batches:
2308JG
2629JG
2636JG
and
Name of the test material (as cited in study report):Proteol APL
batches:
T10841
T11921
T12621
Key result
Type:
relative density
Density:
1.11 g/cm³
Temp.:
20 °C
Remarks on result:
other: no guideline was followed
Remarks:
The relative density was calculated using the measurement of a volume related to a known mass -6 batches were used-. The relative density mean value of the six batches tested using an electric measuring apparatus was: stated to 1.11 at 20 °C
Conclusions:
The relative density mean value of the six batches tested using an electric measuring apparatus was: stated to 1.11 at 20 °C
Executive summary:

No guidline was followed

The relative density was calculated using the measurement of a volume related to a known mass

6 Batches were used

The relative density was stated to 1.11

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method A.3 (Relative Density)
Principles of method if other than guideline:
The relative density at 20° C was measured at the PAAR densimeter. For each of the three batches, two measurements were taken.
GLP compliance:
no
Type of method:
other: PAAR density meter
Specific details on test material used for the study:
Batch numbers:
-1313600046
-1333100039
-1324100061
Key result
Type:
relative density
Density:
>= 1.1 - <= 1.105 g/cm³
Temp.:
20 °C
Conclusions:
The relative density was stated to be 1.103 +/- 0.005 g/cm3 at 20°C.
Executive summary:

The relative density was stated to be 1.103 +/- 0.005 g/cm3 at 20°C.

Endpoint:
relative density
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
Type:
relative density
Density:
ca. 1 g/cm³
Remarks on result:
other: relative density values are available for category members: (i) 1.1 g/cm3, (ii) 1.1-1.105 g/cm3.
Remarks:
relative density values are available for category members: (i) 1.1 g/cm3, (ii) 1.1-1.105 g/cm3.
Conclusions:
A collection of the relative density values is available for category members. Considering these values the registered substance has a relative density of 1 g/cm³.
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.

Description of key information

Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) have density values higher than 1 g/cm3.

Key value for chemical safety assessment

Additional information

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

EC number

Density (g/cm³)

S1 - EC: 918-984-3

>= 1.1 g/cm³

S2 - EC: 927-837-2

>= 1.1 - <= 1.105 g/cm³

 

Overall, registered substance has a relative density of 1 g/cm³