Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
No information
Year:
1987
Bibliographic source:
Kiso to Rinsho. Clinical Report. Vol. 21, Pg. 6307, - CHemIDplus Lite data base

Materials and methods

Principles of method if other than guideline:
Method not published.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide monohydrochloride
EC Number:
251-211-1
EC Name:
5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide monohydrochloride
Cas Number:
32780-64-6
IUPAC Name:
2-hydroxy-5-{1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl}benzamide hydrochloride
Constituent 2
Reference substance name:
Benzamide, 2-hydroxy-5-(1-hydroxy-2-((1-methyl-3- phenylpropyl)amino)ethyl)-, monohydrochloride
IUPAC Name:
Benzamide, 2-hydroxy-5-(1-hydroxy-2-((1-methyl-3- phenylpropyl)amino)ethyl)-, monohydrochloride

Test animals

Species:
rat
Strain:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 114 mg/kg bw

Any other information on results incl. tables

Behavioral: convultion or effect on seizure threshold; altered sleep time (including change in righting reflex).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute oral toxicity study performed on the final product Labetalol HCl showed a LD50 value of 2114 mg/kg. The substance is not classified for this category.