Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Repeated dose toxicity: oral
A repeated dose toxicity with N-ethylmorpholine was performed in rat according to OECD guideline 407 (GLP-compliant). A NOAEL of 200 mg/kg bw/d was derived based on toxicologically relevant adverse effects like clinical observations, decreased body weight gain, organ weight and histopathology.
Repeated dose toxicity: inhalation
No reliable studies were available for this route of exposure. No further testing is needed since a reliable study is available for repeated toxicity via the oral route (REACH Regulation, column 2 adaptation, Annex VIII). 
Repeated dose toxicity: dermal
No reliable studies were available for this route of exposure. No further testing is needed since a reliable study is available for repeated toxicity via the oral route (REACH Regulation, column 2 adaptation, Annex VIII).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity: oral

A subacute oral study (28 days) is performed with N-ethylmorpholine (NEM), in which male and female rats are exposed to 0 (vehicle), 50, 200, or 800 mg/kg bw/d via gavage (according to OECD guideline 407).

The NOAEL for oral repeated dose toxicity in Cjr:CD(SD)IGS rats is considered to be 50 mg/kg/day for both sexes based on cage licking and chewing at 200 and 800 mg/kg/day. These clinical signs do not represent a toxicologically adverse effect and are furthermore not mentioned in an OECD 421 study, performed in the same lab with the same rat strain. A relevant adverse effects are observed at 800 mg/kg/d only, a NOAEL of 200 mg/kg bw/day for both sexes is proposed.

Repeated dose toxicity: dermal and inhalation:

No reliable studies were available for these routes of exposure. However, no further testing is needed since a reliable study is available for repeated toxicity via the oral route (REACH regulation, Column 2 Adaptation, Annex VIII).


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one reliable study available

Justification for classification or non-classification

Based on the outcome of the repeated dose toxicity study via oral administration and the CLP Regulation, NEM should not be classified for STOT repeated exposure.