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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The in vitro genotoxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected to be driven by the properties of its individual constituents. Therefore the in vitro genotoxicity of the substance was assessed based on information on its constituents regarding their capacity to induce gene mutation in bacteria and mammalian cells and structural chromosomal aberration in mammalian cells.

 

Based on a combination of experimental data and valid QSAR predictions, it was concluded that the constituents of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) will not induce gene mutation in bacteria and mammalian cells and structural chromosomal aberration in mammalian cells.

 

It is therefore concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is not expected to induce gene mutation in bacteria and mammalian cells and structural chromosomal aberration in mammalian cells.

 

It is not considered relevant to perform in vitro or in vivo genotoxicity in accordance with Annexes VII and VIII of REACH.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
other: An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
Adequacy of study:
weight of evidence
Study period:
June 06, 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
GLP compliance:
no
Type of assay:
other: In vitro mammalian cell micronucleus test, other (not specified)
Key result
Remarks on result:
other: The substance is not expected to induce structural chromosomal aberration in mammalian cells based on the properties of its constituents.
Conclusions:
An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance. Based on the activity of its constituents, it is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is not expected to induce structural chromosomal aberration in mammalian cells. It is not considered necessary to carry out further testing.
Executive summary:

The potential of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) to induce structural chromosomal aberration in mammalian cells is expected to be driven by the capacity of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, morpholine, and water – to induce structural chromosomal aberration in mammalian cells.

 

Available data and QSAR predictions on these constituents indicate that they will not induce structural chromosomal aberration in mammalian cells

 

Based on the activity of its constituents, it is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is not expected to induce structural chromosomal aberration in mammalian cells. It is not considered necessary to carry out further testing.

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
other: An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
Adequacy of study:
weight of evidence
Study period:
June 06, 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
GLP compliance:
no
Type of assay:
other: An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
Key result
Remarks on result:
other: The substance is not expected to induce gene mutation in bacteria based on the properties of its constituents.
Conclusions:
An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance. Based on the activity of its constituents, it is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is not expected to induce gene mutation in bacteria. It is not considered necessary to carry out further testing.
Executive summary:

The potential of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) to induce gene mutation in bacteria is expected to be driven by the capacity of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, morpholine, and water – to induce gene mutation in bacteria.

 

Available data and QSAR predictions on these constituents indicate that they will not induce gene mutation in bacteria.

 

Based on the activity of its constituents, it is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is not expected to induce gene mutation in bacteria. It is not considered necessary to carry out further testing.

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
other: An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
Adequacy of study:
weight of evidence
Study period:
June 06, 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
GLP compliance:
no
Type of assay:
other: An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance.
Key result
Remarks on result:
other: The substance is not expected to induce gene mutation in mammalian cells based on the properties of its constituents.
Conclusions:
An assessment was performed based on experimental data and QSAR predictions on the constituents of the substance. Based on the activity of its constituents, it is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is not expected to induce gene mutation in mammalian cells. It is not considered necessary to carry out further testing.
Executive summary:

The potential of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) to induce gene mutation in mammalian cells is expected to be driven by the capacity of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, morpholine, and water – to induce gene mutation in mammalian cells.

 

Available data and QSAR predictions on these constituents indicate that they will not induce gene mutation in mammalian cells.

 

Based on the activity of its constituents, it is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is not expected to induce gene mutation in mammalian cells. It is not considered necessary to carry out further testing.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The capacity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) to induce gene mutation in bacteria and mammalian cells and structural chromosomal aberration in mammalian cells was assessed using a combination of available experimental data and valid QSAR predictions on the individual constituents of the substance. As none of these constituents are genotoxic it was concluded that the substance was not genotoxic.

 

In accordance with Annexes VII and VIII of REACH it was not required to consider in vivo genotoxicity testing on Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) as no positive result was obtained.

 

As a conclusion Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) does not meet the criteria for classification as mutagenic in accordance with Regulation (EC) N° 1272/2008.