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Diss Factsheets

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

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) did not meet the criteria for classification according to Regulation (EC) No.1272/2008.