Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-10-04 to 1991-02-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: according to OECD 402, GLP lack of data on the purity / quality of the sample tested

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2-Benzyl-2-methyl-3-butennitrile
IUPAC Name:
2-Benzyl-2-methyl-3-butennitrile
Constituent 2
Reference substance name:
Citrowanil B, colourless spicy liquid
IUPAC Name:
Citrowanil B, colourless spicy liquid
Details on test material:
Citrowanil B

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Sprague-Dawley rats: Breeding Interfauna, Süddeutsche Versuchstierfarm, Tuttlingen
Veterinary preliminary examination: without morbid signs
Diet: Haltungsdiät alma 0801 H 1003, twice 8g daily
Water: free access by daily changing
Husbandry: the animals housed individually in Macrolon cages (area 800 cm², height 17 cm)
Temperature: 20 – 22 °C
Relative humidity: 45 – 70 %
Light-dark rhythm: 12 : 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
One day before the application the dorsal area of the trunk was shaved in an area of 10 per cent of the body surface.
The liquid test substance was undiluted applied on the dorso-lumbar region of the rats.
The treated region was protected with gauze and an occlusive bandage for a period of 24 hours.

The animals were acclimatized to the test conditions for 5 days prior to the application.
Duration of exposure:
24 hours
At the end of the exposure period residual test substance was removed by gentling washing with water.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Judgement during the study:
Mortality, behaviour, nutritional conditions, body weight, excrement, urine, hair, skin, nose, mouth, analregion, eye, respiration, nervous system, pathological findings
Statistics:
not nescessary

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD100
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
After the dermal application of 2000 mg Citrowanil B per kg body weight none of the 10 rats died during the observation period of 14 days.
Clinical signs:
During the exposure period of the test substance (24 hours) the food intake was reduced. In the remaining observation time the food was eaten up regularly and completly.
Acute toxicological signs were found in one male rat with bloody urine only during the exposure period of the first day. In other rats no toxicological signs were found.
After the exposure period of 24 hours no dermal irritations of the exposure area were seen.
Body weight:
The body weight of all rats had a growth during acclimatization and observation period. Only in the first day after the application variations were observed.
Details: see Table in “Any other information”
Gross pathology:
The post-mortem findings after euthanasia (in CO2-atmosphere) did not show any macroscopic organ changes.

Any other information on results incl. tables

Body weights in g

testphase

day

male animals No

female animals No

 

 

1

2

3

4

5*

1

2

3

4

5

acclimatization

-5

212

210

225

214

220

215

210

220

218

205

 

-4

215

213

228

216

217

215

213

222

219

208

 

-3

217

215

232

221

223

220

215

223

221

212

 

-2

222

218

234

220

228

222

215

225

225

215

 

-1

226

219

235

225

232

225

216

229

228

218

application

0

210

209

230

216

230

218

209

219

215

209

observation

1

212

201

225

210

232

212

207

210

212

200

 

2

207

210

230

221

228

217

212

215

219

210

 

3

205

205

229

219

230

213

209

214

215

209

 

4

212

210

228

219

242

214

210

215

219

210

 

5

217

219

231

221

246

215

209

217

218

210

 

6

220

223

239

224

246

217

215

221

225

216

 

7

224

226

248

226

248

222

218

225

227

219

 

8

224

227

249

228

-

223

218

224

228

218

 

9

-

-

-

-

254

-

-

-

-

-

 

10

223

226

250

233

261

230

221

230

232

221

 

11

220

230

258

242

-

240

218

240

231

230

 

12

-

-

-

-

260

-

-

-

-

-

 

13

228

232

250

238

262

244

223

238

230

236

 

14

228

230

258

238

263

245

226

241

233

240

 

* Day of application one day later than the other animals. This animal showed the bloody sings in the urine during the exposure period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
LD50 dermal, rat: > 2000 mg/kg b.w.
Not any skin irritation.
Executive summary:

The Acute Dermal Toxicity of Citrowanil B was determined in compliance with OECD 402 (1987).

Citrowanil B was applied in a dose of 2000 mg per kg weight dermal in each case to 5 male and 5 female Albino-Sprague Dawley rats.

Under the condition of this experiment Citrowanil B did not show any mortality.

Therefore, the experiment was finished as a limit test (LD50 dermal mor than 2000 mg per kg weight).

Acute toxicological signs were found in one male rat with bloody urine only during the exposure period of the first day. In other rats no toxicological signs were found.

The body weight of all rats had a normal physiological growth. Only in the first day after the application variations were observed.

The post-mortem findings after euthanasia did not show any macroscopic organ changes.