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Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Adequacy of study:
other information

Data source

Reference Type:
other: Body responsible for the test

Materials and methods

Test guideline
according to
other: EEC-Directive 92/69 B.1-bis.
GLP compliance:
Test type:
fixed dose procedure

Test animals

other: rat, Wistar strain Crl: (WI) BR

Administration / exposure

other: Propylene glycol (specific gravity 1.036).
No. of animals per sex per dose:
Preliminary sighting study: 4 (male)
Preliminary sighting study: 4 (female)
Main study: 5 (male)
Main study: 5 (female)
Details on study design:
Preliminary sighting study:
2000 mg/kg: The two males died and the two females were
killed in extremis within 2 hours after dosing.

500 mg/kg: The male and female died within 24 hours after

50 mg/kg: No mortality occurred.

Main study:
As no mortality occurred at the dose level of 50 mg/kg in
the preliminary sighting study, the main study was conducted
with a fixed dose of 50 mg/kg body weight administered to
five rats of each sex.

Results and discussion

Preliminary study:
Species/strain: rat, Wistar strain Crl: (WI) BR
2000 mg/kg bw: Evident toxicity: Y; Mortality: Y
500 mg/kg bw: Evident toxicity: Y; Mortality: Y
50 mg/kg bw: Evident toxicity: Y; Mortality: N
mg/kg bw: Evident toxicity: ; Mortality:

At 2000 mg/kg (2M/2F tested): spasms (2M/2F); pale skin
(2M); salivation (2M). Males died day 1; females killed in
extremis day 1.

At 500 mg/kg (1M/1F tested): lethargy (1M); spasm (1M/1F);
ventro-lateral recumbency (1M); uncoordinated movements
(1M/1F). Male: died day 2; female: died day 1.

50 mg/kg (1M/1F tested): lethargy: (M/F); hunched posture
(M/F); uncoordinated movements (M/F); piloerection: (M/F).
Secheduled necropsy day 8.

Macroscopic findings:

2000 mg/kg: males: stomach: hemorrhage (glandular mucosa);
thickened, red-brown forestomach; liver: discoloration,

Females: same as males: in addition: red-brown discoloured
lungs and hemorrhage of the left side cortex of the adrenal

At 500 mg/kg: male: enlarged stomach.

female: dark red discolouration of the glandular mucosa of
the stomach and a thickened forestomach.

At 50 mg/kg: no findings noted.
Effect levelsopen allclose all
Dose descriptor:
discriminating dose
Effect level:
50 mg/kg bw
Dose descriptor:
other: 50 mg/kg bw (fixed dose initial)
Remarks on result:
other: No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5
Clinical signs:
Signs of toxicity:
Hunched posture and uncoordinated movements were noted in
all animals on day 1.
Gross pathology:
Effects on organs:
No findings.
Other findings:

Applicant's summary and conclusion

Interpretation of results:
Migrated information