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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
The toxicologic and pharmacologic properties of amantadine hydrochloride.
Author:
Vernier VG, Harmon JB, Stump JM, Lynes TE, Marvel JP, Smith DH
Year:
1969
Bibliographic source:
Toxicol Appl Pharmacol. 1969, 15(3):642-65.

Materials and methods

Principles of method if other than guideline:
The acute toxicity after oral administration of the test substance was determined in male and female rats (Carworth Farms, CFE) over a 7-14-day observation period. At least 5 dose levels with 10 animals each were studied using narrow dose increments as aqueous solutions at a volume of 10 mL/kg bw. The LD50 and 95% confidence limits were calculated by the method of Miller and Tainter (1944), Proc. Soc. Exptl. Biol. Med. 57, 261-264.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
Amantadine hydrochloride
EC Number:
211-560-2
EC Name:
Amantadine hydrochloride
Cas Number:
665-66-7
IUPAC Name:
adamantan-1-amine hydrochloride
Details on test material:
- Name of test material (as cited in study report): 1-adamantanamine hydrochloride
- Physical state: white crystalline substance
- Analytical purity: no data

Test animals

Species:
rat
Strain:
other: Carworth Farms CFE
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 113-141 g (males); 87 - 117 g (females)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: soluble in water (40% w/v).

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:
at least 5 dose levels using narrow dose increments (not specified)
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 to 14 days
Statistics:
The LD50 and 95% confidence limits were calculated by the method of Miller and Tainter (1944) Proc. Soc. Exptl. Biol. Med. 57, 261-264.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
890 mg/kg bw
Based on:
test mat.
95% CL:
761 - 1 019
Sex:
male
Dose descriptor:
LD50
Effect level:
1 275 mg/kg bw
Based on:
test mat.
95% CL:
1 095 - 1 455
Sex:
male/female
Dose descriptor:
LD50
Effect level:
890 - 1 275 mg/kg bw
Based on:
test mat.
Mortality:
All death occured 30 min to 24 hours after oral doses.
Clinical signs:
other: Central nervous system stimulation followed by tremors and brief clonic convulsions. Death was preceded by signs of respiratory distress and convulsions

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU