Registration Dossier
Registration Dossier
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EC number: 245-396-8 | CAS number: 23047-25-8
Endpoint summary
Administrative data
Description of key information
Two acute toxicity values are available, as secondary source, for Lofepramine:
mouse, LD50, oral > 2500 mg/kg
rat, LD50, oral > 1000 mg/kg
Since in one case the LD50 is major than 2000 mg/kg it can be concluded that the substance is not classified as Acute Oral Toxicity.
Two acute subcutaneous toxicity values are available, as secondary source, for Lofepramine:
mouse, LD50, sc > 1000 mg/kg
rat, LD50, sc >1000 mg/kg
In this case data are inconclusive regarding classification.
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
- Specific details on test material used for the study:
- Details on test material are not available since coming from a secondary source
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mouse oral LD50 for lofepramine is >2500 mg/kg .
- 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
- Specific details on test material used for the study:
- Details on test material are not available since coming from a secondary source
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Rat oral LD50 for lofepramine is >1000 mg/kg.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Specific details on test material used for the study:
- Details on test material are not available since coming from a secondary source
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on dermal exposure:
- The substance was administered by subcutaneous route.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- data from subcutaneus administration
- Effect level:
- > 1 000 mg/kg bw
- Interpretation of results:
- study cannot be used for classification
- Executive summary:
LD50 Mouse sc >1000 mg/kg
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Specific details on test material used for the study:
- Details on test material are not available since coming from a secondary source
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on dermal exposure:
- The substance was administered by subcutaneous route.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- data from subcutaneus administration
- Effect level:
- > 1 000 mg/kg bw
- Interpretation of results:
- study cannot be used for classification
- Executive summary:
LD50 rat sc >1000 mg/kg
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
- Quality of whole database:
- No data are available for dermal administration. Data available for subcutaneous route do not allow to exclude the classification for this hazard class.
Additional information
Justification for classification or non-classification
Two acute oral toxicity values are available, as secondary source, for Lofepramine:
mouse, LD50, oral > 2500 mg/kg
rat, LD50, oral > 1000 mg/kg
Since in one case the LD50 is higher than 2000 mg/kg it can be concluded that the substance is not classified as Acute Oral Toxicity.
No data are available for dermal administration. Data available for subcutaneous route do not allow to exclude the classification for this hazard class.
Overall, the substance Lofepramine is deemed to be not classified for Acute toxicity.
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