Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977-09-02 to 1978-02-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name: Cumyl peroxyneodecanoate (SN-1-4462-71)
- Purity: 90.2%
- Appearance: viscous yellowish liquid

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan
- Weight at study initiation: 200 - 248 g
- Housing: Animals were housed by sex in groups of 5 rats per cage in hanging wire-mesh cages
- Water: ad libitum
- Diet: ad libitum; Purina Laboratory Chow (withheld during overnight period preceding oral administration)
- Temperature and humidity controlled quarters

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
once (to male and female): 2034, 3229, 5126, 8137, 12918 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

OBSERVATIONS
- Weighing: Initially, at 7 and 14 days
- Mortality/Viability: During first four hours after dosing, at 24 hours and daily thereafter
Statistics:
Statistical Reference
LD50 values and associated 95% confidence interval, slope of dose mortalitiy curve
References:
- Weil, C.S. 1952. Tables for Convenient Calculation of Median Effective Dose and Instruction in Their Use. Biometrics, 8: 249 - 263
- Thompson, W.R. and Weil, C.S. 1952. On the Construction of Tables for Moving Average Interpolation. Biometrics, 8: 51 - 54
- Eby, R. 1957. Statistical Tables for Dose Evaluation, Report No. 5711. Miles - Ames Research Laboratoy, Elkhart, Indiana

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
4 068 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 132 - <= 5 284
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 458 mg/kg bw
Based on:
test mat.
95% CL:
>= 5 590 - <= 7 462
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 126 mg/kg bw
Based on:
test mat.
95% CL:
>= 4 294 - <= 6 118
Mortality:
At 8137 and 12918 mg/kg all animals died. At 5126 mg/kg 4/5 female animals were found dead and at 3229 mg/kg 1/5 female animals died. No deaths occured at a dose of 2034 mg/kg.
For individual results see Table 1 in box 'Any other information on results incl. tables'.
Clinical signs:
No data
Body weight:
A trend in decreasing body weight gain is observed in survived animals.
For individual results see Table 1 in box 'Any other information on results incl. tables'.
Gross pathology:
No data

Any other information on results incl. tables

Table 1: Mortality and LD50 Values

Exposure Conc. mg/kg

Number of Deaths

Total Mortalities

 

Postexposure

Hrs.

Days

0 - 4

1

2

3

4

5

6

7 - 14

M

F

M

F

M

F

M

F

M

F

M

F

M

F

M

F

Male

Female

Total

2034

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

0/5

0/5

0/10

3229

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

0/5

1/5

1/10

5126

 

 

 

2

 

2

 

 

 

 

 

 

 

 

 

 

0/5

4/5

4/10

8137

1

3

3

2

 

 

1

 

 

 

 

 

 

 

 

 

5/5

5/5

10/10

12918

5

5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5/5

5/5

10/10

The Acute Oral LD50 Values and 95% Confidence Limits

Male Rats: 6458 (5590 - 7462)

Female Rats: 4068 (3132 - 5284)

Combined Male and Female Rats: 5126 (4294 - 6118)

Slope

Male Rats: 1.66

Female Rats: 1.66

Combined Male and Female Rats: 1.66

Table 2: Body Weights obtained during 14 -day observation period

Dosage Level mg/kg

Individual Rat No.

Sex

Control Weight (grams)

7-Day Weight (grams)

14-Day Weight (grams)

2034

70485

Male

211

295

334

70486

Male

231

272

286

70487

Male

244

312

343

70488

Male

248

296

323

70498

Male

243

291

324

70490

Female

214

248

256

70491

Female

210

243

258

70492

Female

208

242

273

70493

Female

202

247

254

70494

Female

200

224

243

3229

70354

Male

200

258

310

70355

Male

221

245

292

70356

Male

215

281

312

70357

Male

201

264

324

70358

Male

213

280

325

70349

Female

212

234

226

70350

Female

200

240

246

70351

Female

214

238

260

70352

Female

200

Died

Died

70353

Female

216

252

241

5126

70364

Male

200

211

222

70365

Male

201

244

308

70366

Male

205

269

318

70367

Male

202

225

258

70368

Male

207

248

288

70359

Female

200

235

216

70360

Female

200

Died

Died

70361

Female

201

Died

Died

70362

Female

220

Died

Died

70363

Female

210

Died

Died

8137

70374

Male

201

Died

Died

70375

Male

203

Died

Died

70376

Male

208

Died

Died

70377

Male

205

Died

Died

70378

Male

200

Died

Died

70369

Female

210

Died

Died

70370

Female

218

Died

Died

70371

Female

220

Died

Died

70372

Female

206

Died

Died

70373

Female

204

Died

Died

12918

70384

Male

215

Died

Died

70385

Male

200

Died

Died

70386

Male

210

Died

Died

70387

Male

200

Died

Died

70388

Male

200

Died

Died

70379

Female

204

Died

Died

70380

Female

200

Died

Died

70381

Female

210

Died

Died

70382

Female

210

Died

Died

70383

Female

202

Died

Died

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The presented studies finds that 1-Methyl-1-phenylethyl peroxyneodecanoate is not of acute oral toxicity and that GHS criteria are not met.
Executive summary:

In a primary acute oral toxicity study (similar to OECD 401), Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (1-Methyl-1-phenylethyl peroxyneodecanoate, 90.2% purity), suspended in corn oil. Animals then were observed for 14 days. Due to mortality distribution, the oral LD50 in rats in considered to be 6458 mg/kg bw for males, 4068 mg/kg bw for females and 5126 mg/kg bw for both sexes.