Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study + GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(3-hydroxypropyl)oxazolidin-2-one
EC Number:
431-840-1
EC Name:
3-(3-hydroxypropyl)oxazolidin-2-one
Cas Number:
87010-29-5
Molecular formula:
C6 H11 N O3
IUPAC Name:
3-(3-hydroxypropyl)oxazolidin-2-one
Details on test material:
- Name of test material (as cited in study report): 0xypropazone
- Physical state: Slightly yellowish, vlscous llquid
- Analytical purity: 96.5%
- Lot/batch No.: #120446 / 7.12.90
- Stability under test conditions: Stability is guaranteed throughout the experimental period
- Storage condition of test material: The test material was kept in a closed container at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bor:WISW (SPF-Cpb)
- Age at study initiation: Males 8 weeks, females 9 weeks
- Weight at study initiation: Males 176-197, females 147-159 g
- Housing: Macrolon cages, type II, one animal per cage
- Diet: Standard diet ad libitun, ssniff R, Special diet for rats
- Water: ad libitum
- Acclimatization: Animals were kept at least five days under test conditions before administration
- Fasting period before study: approximately 16 h

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 50-65
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Desalted water

MAXIMUM DOSE VOLUME APPLIED: 21.5 ml

Doses:
5110 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 16 days
- Frequency of observations and weighing: once daily observation, weighing on day 0, 7 and 14
- Necropsy of survivors performed: yes (gross necroscopy)
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Mortality:
Male: 5110 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5110 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: slight Hypokinesia, restrained gait, sunken sides, and piloerection.
Symptoms were recorded in all animals and were present beween 30 minutes and two days after treatment.
Body weight:
see table below
Gross pathology:
Effects on organs:
No alterations were detected.

Any other information on results incl. tables

Dose

Animal No

Day 0

Day 7

Day 14

5110

1

 

181

 

234

 

284

5110

2

186

225

256

5110

3

197

243

284

5110

4

176

225

261

5110

5

179

215

246

5110

6

 

156

 

182

 

195

5110

7

159

184

191

5110

8

147-

171

179

5110

9

158

193

194

5110

10

155

181

185

Body weights [g]

Applicant's summary and conclusion