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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Two acute oral toxicity values are available, as secondary source, for metoclopramide:

mouse, LD50, oral = 270 mg/kg

rat, LD50, oral = 750 mg/kg.

Even if the LD50 for mouse trigger to the classification as Acute Tox. 3, as stated in CLP Regulation the preferred test species for evaluation of acute toxicity by the oral and inhalation routes is the rat. Therefore, the substance is classified as Acute Tox. 4 H302.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
750 mg/kg bw
Based on:
test mat.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Rat oral LD50 for metoclopramide is 750 mg/kg.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
750 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Even if the oral LD50 for mouse trigger to the classification as Acute Tox. 3, as stated in CLP Regulation the preferred test species for evaluation of acute toxicity by the oral and inhalation routes is the rat. Therefore, the substance is classified as Acute Tox. 4 H302.