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Toxicological information

Acute Toxicity: oral

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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:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Principles of method if other than guideline:
The purpose of this study was to determine if the LD50 of the test substance exceeded 5000 mg/kg. If all animals dosed at 5000 mg/kg survive the 15-day test period, the LD50 is assumed to be greater than 5000 mg/kg. In addition, clinical signs of abnormality and gross pathologic changes observed in the dosed animals were used in assessing the toxicity of the test material.

Single oral doses of the test material, as suspensions in Mazola® corn oil, were administered by intragastric intubation to a group of 5 male and 5 female rats at a dose rate of 5000 mg/kg of body weight. Rats were fasted approximately 24 hours prior to dosing, with food being returned to the animals approximately one hour after dosing. Individual dose volumes were calculated using fasted body weights obtained prior to dosing. Observations for mortality were made daily throughout the study. Rats were weighed and observed daily (weekends excluded) for clinical signs of toxicity. At study termination, 3 rats per sex were necropsied.
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
-Purity: 96.8%

Test animals

Species:
rat
Strain:
other: Crl:CD®(SD)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New York
- Females (if applicable) nulliparous and non-pregnant: No data are available on females
- Age at study initiation: Approximately 7 weeks old
- Weight at study initiation: Males: 214g Range: [207-219g] and Females: 166g [Range: 157-173g]
- Fasting period before study: 24 hours prior to dosing
- Housing: Rats were housed singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow® #5002
- Water (e.g. ad libitum): No data are available on source of the water
- Acclimation period: Approximately one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23° ± 2°C
- Humidity (%): 50% ± 10%
- Air changes (per hr): No data are available
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
Mazola®
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 300 mg/mL
- Amount of vehicle (if gavage): Males: 3.6 mL; Females: 2.8 mL
- Justification for choice of vehicle: Not provided
- Lot/batch no. (if required): Not provided
- Purity: Not provided
Doses:
5000 mg/kg
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: 14 days
- Frequency of observations and weighing: daily (weekends excluded)
- Necropsy of survivors performed: yes (3 rats per sex)
- Other examinations performed: clinical signs, body weights
Statistics:
No

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no deaths at the highest dose tested
Mortality:
No deaths were recorded
Clinical signs:
There were no clinical signs of toxicity observed in any of the rats throughout the study.
Body weight:
Sporadic, slight, weight losses (up to 3% of previously measured body weights (see Table 1)
Gross pathology:
Gross pathological examination of rats killed after a 14-day observation period revealed no specific organ toxicity.

Any other information on results incl. tables

Male rats (All weights are in grams)

 

Animal #

Initial weight

Fasted weight

Weight on Day 1

Weight on Day 4

Weight on Day 5

Weight on Day 6

Weight on Day 7

Weight on Day 8

Weight on Day 11

Weight on Day 12

Weight on Day 13

Weight on Day 14

398420

243

214

244

266

275

279

284

295

319

326

332

337

398421

240

211

231

258

260

269

276

284

323

318

323

333

398422

246

218

235

269

277

281

291

300

312

328

333

331

398423

238

207

229

261

265

268

276

283

308

323

327

327

398424

248

219

242

270

277

280

283

290

310

318

330

328

 

Female rats (All weights are in grams)

 

Animal #

Initial weight

Fasted weight

Weight on Day 1

Weight on Day 4

Weight on Day 5

Weight on Day 6

Weight on Day 7

Weight on Day 8

Weight on Day 11

Weight on Day 12

Weight on Day 13

Weight on Day 14

398571

185

164

181

200

209

205

207

213

227

228

225

220

398572

181

157

174

186

186

181

189

191

201

203

202

202

398573

188

166

188

197

205

206

207

207

218

217

218

215

398574

188

170

188

203

207

206

204

212

228

225

232

233

398575

196

173

191

212

205

216

222

226

241

244

240

236

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (rats) > 5000 mg/kg
Executive summary:

The purpose of this study was to determine if the LD50 of the test substance exceeded 5000 mg/kg. If all animals dosed at 5000 mg/kg survive the 15-day test period, the LD50 is assumed to be greater than 5000 mg/kg. In addition, clinical signs of abnormality and gross pathologic changes observed in the dosed animals were used in assessing the toxicity of the test material.

There were no mortalities associated with the dose given. The LD50 for both male and female rats was greater than 5000 mg/kg of body weight, the highest dose tested. Other than sporadic, slight, weight losses (up to 3% of previously measured body weights) there were no clinical signs of toxicity observed in any of the rats throughout the study. Gross pathological examination of rats killed after a 14-day observation period revealed no specific organ toxicity.