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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation, other
Type of information:
other: Assessment based on experimental data on individual constituents of the substance
Adequacy of study:
key study
Study period:
June 06, 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessment based on experimental data on individual constituents of the substance

Data source

Reference
Reference Type:
other: Expert assessment
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment based on experimental data on individual constituents of the substance
GLP compliance:
no
Type of study:
other: Assessment based on experimental data on individual constituents of the substance

Test material

Constituent 1
Chemical structure
Reference substance name:
morpholin-4-ium morpholine 6-(4-methylbenzenesulfonamido)hexanoate
EC Number:
944-090-8
Molecular formula:
C13H19NO4S.C4H9NO/C4H9NO/H2O
IUPAC Name:
morpholin-4-ium morpholine 6-(4-methylbenzenesulfonamido)hexanoate
Test material form:
liquid

Results and discussion

In vivo (LLNA)

Results
Key result
Parameter:
other: skin sensitisation
Remarks on result:
other: Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is not expected to induce skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An assessment of the capacity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) was performed based on experimental data on individual constituents of the substance. 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 skin sensitisation.
Executive summary:

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

 

A GLP-compliant skin sensitisation study has been performed on 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid that concluded that the substance is not a skin sensitiser.

Available literature data on morpholine indicated that the substance was not a skin sensitiser.

As a substance included in Annex IV of REACH, water is not considered as a skin sensitiser.

 

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 skin sensitisation. No further testing is considered as required.