Registration Dossier
Registration Dossier
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EC number: 208-964-6 | CAS number: 549-18-8
Endpoint summary
Administrative data
Description of key information
Several acute oral toxicity values are available for Amitriptyline hydrochloride, the most relevant values are summarized below.
rat, LD50, oral = 240 mg/kg
mouse, LD50, oral = 140 mg/kg
Overall, available data are sufficient to classify the substance as Acute Tox. 3 H301.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 140 mg/kg bw
- Based on:
- not specified
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- For amitriptyline hydrochloride the mouse, LD50 by oral oral route was 140 mg/kg bw.
- 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:
- 240 mg/kg bw
- Based on:
- not specified
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- For amitriptyline hydrochloride the rat, LD50 by oral route was 240 mg/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
