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Description of key information

A study (Wyeth-Ayerst Laboratories, 1985) using rat  was available. The approx. LD50 for male was 672.7 mg/kg bw, for female was 336.4 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April to May 1984
1 (reliable without restriction)
no guideline followed
Principles of method if other than guideline:
This study used rat (male/female), and the dosage was 3, 10, 50, 200, 400 and 600 mg/kg bw.
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
other: CRL:CD (SD) BR
Details on test animals or test system and environmental conditions:
- Source:Charles River Breeding Laboratories, Inc., Wilmington, MA 01887
- Age at study initiation:6 to 7 weeks
- Weight at study initiation:110 to 209 grams
- Fasting period before study:Rats were deprived of food overnight prior to, and 1 hour following administration.
- Housing:Metal and wire mesh suspended cages
- Diet (e.g. ad libitum):Purina Rodent Laboratory Chow No. 5001 (Checkers). Food is freely offered at all other times.
- Water (e.g. ad libitum):Tap water in individual bottles. Water is offered ad libitum throughout the study.
- Acclimation period:7 to 8 days
Route of administration:
other: oral gastric intubation
other: sterile water
Dose range testing:
Male: 100, 200, 400, 600, 800, 1000, 1740, 2950 mg/kg
Female: 100, 200, 280, 400, 600 mg/kg
No effect testing: 3, 10 and 50 mg/kg
Dose volume: 5 ml/kg
No. of animals per sex per dose:
3 females and 3 males per dose
Control animals:
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing:during the first day amd at least daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,gross visceral abnormalities
Dose descriptor:
Effect level:
>= 200 - < 400 mg/kg bw
Based on:
test mat.
Dose descriptor:
Effect level:
>= 200 - < 280 mg/kg bw
Based on:
test mat.
Dose descriptor:
approximate LD50
Effect level:
672.7 mg/kg bw
Based on:
test mat.
95% CL:
>= 327.8 - <= 1 058.8
Dose descriptor:
approximate LD50
Effect level:
336.4 mg/kg bw
Based on:
test mat.
95% CL:
>= 179.6 - <= 789.2
All deaths occurred from 8 minutes to approximately 4 hours after dosing. Immediate antemortem observations included tonic convulsions, a loss of righting reflex and dyspnea with subsequent respiratory arrest.
Clinical signs:
other: Mydriasis, salivation and evidence of a combination of central nervous system depression, motor incoordination (decreased motor activity, bradypnea, ataxia, tremors), and CNS excitation (tonic convulsions, straub tail). Effects began within 1 minute after
Gross pathology:
From gross visceral examinations, rats that died after doses of 280, 400, 600, 800, 1000, 1740 and 2950 mg/kg: heart activity was present and there were no remarkable abnormalities found.
Rats that were sacrificed 7 days after doses of 3, 10, 50, 100, 200, 280, 400, 600, 800 and 1000 mg/kg: There were no remarkable abnormalities
Interpretation of results:
Toxicity Category IV
Migrated information
No-Effect dose: 50 mg/kg (male and female)
Lowest dose administered at which death occurred: Male-400 mg/kg; Female-280 mg/kg.
Highest dose administered which was non-lethal: 200 mg/kg (male and female)
Approximate Median Lenthal Doses (95% confidence limits):
Male: 672.7 (327.8-1058.8) mg/kg; Female: 336.4 (179.6-789.2) mg/kg
These results suggest a possible sex-related difference in the lethality of WY-45,030 HCl, with females having greater sensitivity than males.
Executive summary:

An acute oral toxicity study of WY-45,030 HCl showed approx.LD50 to be 672.7 and 336.4 mg/kg for males and females, respectively. And females had greater sensitivity than males.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
336.4 mg/kg bw
Quality of whole database:
acute toxic class method

Additional information

A study (Wyeth-Ayerst Laboratories, 1985) using rat was available. Key study.

The study showed that the approx. LD50 for male was 672.7 mg/kg bw, for female was 336.4 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
A study using rat was available.

Justification for classification or non-classification

The approx. LD50 for male was 672.7 mg/kg bw, for female was 336.4 mg/kg bw.

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1 the substance is classified as Category 4 for the acute toxicity endpoint.

Specific Target Organ Toxicity - Single Exposure There were no remarkable abnormalities. No specific target organ toxicity was observed following single exposure to the substance. Therefore, classification with STOT SE is not assigned.