Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1)

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

other: An assessment was undertaken based on available data on the individual constituents of the substance

Adequacy of study:

key study

Study period:

May 15, 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was undertaken based on available data on the 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:

An assessment was undertaken based on available data on the individual constituents of the substance

GLP compliance:

no

Test material

Test material information

Constituent 1

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

Results of examinations

Gross pathological findings:

effects observed, treatment-related

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

140 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

body weight and weight gain

urinalysis

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

An assessment was undertaken based on available data on the 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) has a NOAEL = 140 mg/kg bw/d and

Executive summary:

An assessment on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) following exposure via the oral route was undertaken based on available data on the individual constituents of the substance. It concluded that is not necessary to conduct a new study on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1), because substantial repeated dose toxicity data is already available in the literature for the constituents of the reaction mass and the repeated-dose toxicity of the substance is expected to be driven by its individual constituents.

Using the most conservative approach, the lowest value across the two constituent substances of the reaction mass has been taken. This approach is considered to be conservative. Therefore, it can be concluded that the short-term repeated dose toxicity value for Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is NOAEL = 140 mg/kg bw.

Based on the classification of the constituents of the registered substance, it is concluded that it will not trigger the specific target organ toxicity (STOT) classification in accordance with Regulation (EC) N° 1272/2008.