Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-09-19 to 1990-11-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test according to OECD guideline 401 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990, but lack of data on the purity / quality of the sample tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Hydroxyambran

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Animals:
Species: rat
Strain: Crl.: (WI)BR – Wistar, white
Source: Firma Charles River wiga, Sandhofer Weg 7, 8714 Sulzfeld
Date of receipt August 29, September 19 and October 04, 1990
Acclimation period: at least 7 days
Animal selection: random
Animal identification: with colored markings; cage labelled with dosage, sex, date of study initiation, project no.
Weight range at
study initiation: m: 216 – 247 g; f: 196 – 227 g

Husbandry:
Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type III)
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 21 +/- 2 °C
Relative humidity: 50 – 85 %
Measurement: with thermohygrometer twice daily
Diet: Administration: ad libitum*
Manufacturer: Ssniff Spezialdiäten GmbH, 4770 Soest Westfahlen
Name: Ssniff-R, Alleindiät
Form: Pellets
Water: Administration: ad libitum
System: drinking bottles
Quality: Drinking water as for human consumption
Quality control: half-yearly analyses and bacteriological tests

*The animals were fasted from 16 h before until 3-4 h after administration of the test article.

Prior to study initiation, the animals were acclimated to laboratory conditions for at least 7 days. Only healthy animals were used in the test.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Details on oral exposure:
The test article was administered as a dilution of 50 % in vegetable oil. The pH value was 5.5.
A single oral administration of the test article was perfomed by gavage using a stomach tube.
Doses:
10 000 mg/kg body weight
No. of animals per sex per dose:
Range finding (preliminary study): 2 female animals
Main test: 5 male and 5 female animals
Control animals:
no

Results and discussion

Preliminary study:
There were no deaths in the preliminary study with 10 000 mg/kg bw.
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the course of main study.
Clinical signs:
Abnormal clinical signs such as reduced activity, abnormal gait, abdominal position, reduced grip strength and limb tone and piloerection were observed within 1h - 48h p.a.
Body weight:
Weight gains were normal in all animals.
Gross pathology:
Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.

Any other information on results incl. tables

Body weights:

Individual Values:

Animal No.

Sex

Day 0

Day 7

Day 14

1

m

247

290

330

2

m

242

303

363

3

m

200

276

314

4

m

216

282

330

5

m

242

303

368

6

w

227

274

285

7

w

206

253

273

8

w

223

245

268

9

w

196

232

260

10

w

203

234

262

 

Mean Values:

Sex

n

Day 0

Day 7

Day 14

males

5

229

291

341

females

5

211

248

270

m + f

10

220

269

305

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value for male and female animals is greather than 10 000 mg/kg bw.
Executive summary:

The acute oral toxicity of Hydroxyambran was determined according to the OECD Test Guideline 401 in a limit test with 10 000 mg/kg bw in rats.

No animals died during the course of the study.

Abnormal clinical signs were observed only within 1h - 48h p.a.

Weight gains were normal in all animals.

Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.

The LD50 value for male and female animals is greather than 10 000 mg/kg bw.