Registration Dossier

Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline specified in the study report. Non GLP-Study. Documentation sufficient.

Data source

Reference Type:
study report

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
The purpose of this test was to determine an approximate lethal dose (ALD) of H-25285 when administered as a single oral dose to male rats. The ALD was defined as the lowest dose administered which caused death either on the day of dosing or within 14 days post exposure.
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Test animals

Crj: CD(SD)

Administration / exposure

Route of administration:
oral: gavage
corn oil
Details on oral exposure:
H-25285 was administered as a single oral dose by intragastric intubation to male rats.
450, 670, 1000, 1500, 2300, and 3400 mg/kg
No. of animals per sex per dose:

Results and discussion

Effect levels
Dose descriptor:
approximate LD50
Effect level:
ca. 670 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

The lowest dose of H-25285 which resulted in the death of a test animal was 670 mg/kg. The survival of rats dosed at 1000 or 1500 mg/kg is attributed to animal variability. The dose regimen and the mortality resulting over the 15-day test period are detailed below.

Dose (mg/kg) Volume (mL) Suspension Concentration (mg/mL) Initial Body Weight (g) Mortality

450 0.29 350 226.0 No

670 0.84 150 188.5 Yes

1000 0.59 350 204.9 No

1500 0.93 350 216.7 No

2300 2.9 150 191.1 Yes

3400 2.3 350 237.4 Yes

The rat dosed at 450 mg/kg exhibited no clinical signs or body weight loss during the study. The rat dosed at 1000 mg/kg exhibited brown nasal discharge on test day 3 and body weight loss of approximately 19% of initial weight by 4 days after dosing. The rat dosed at 1500 mg/kg exhibited wet chin on the day of dosing and brown nasal discharge on test day 5. This rat also had weight loss of approximately 20% of initial weight by 6 days after dosing.

Lethal Doses

Dry brown nasal discharge and yellow stained perineum were observed up to 5 days after dosing in the rat dosed at 670 mg/kg. The rat dosed at 2300 mg/kg exhibited lethargy, prostrate posture, dry red oral discharge, and wet or yellow-stained perineum by 2 days after dosing. The rat dosed at 3400 mg/kg exhibited red ocular discharge and yellow stained perineum on test day 3.

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Migrated information
Under the conditions of this study, the oral ALD for H-25285 was 670 mg/kg of body weight. This substance is considered to be slightly toxic (ALD 500 - 5000 mg/kg) when administered as a single oral dose to male rats.

Categories Display