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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
Study period:
09 Mar 2011 - 13 Apr 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassay, Labor für biologische Analytik GmbH, INF 515, 69120 Heidelberg
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol, ethoxylated
EC Number:
500-075-4
EC Name:
Glycerol, ethoxylated
Cas Number:
31694-55-0
Molecular formula:
(C2 H4 O)n (C2 H4 O)n (C2 H4 O)n C3 H8 O3 3n =>1-<6.5 mol EO
IUPAC Name:
Glycerol, ethoxylated
Details on test material:
- Name of test material (as cited in study report): Lupranol VP 9209
- Test item number: 11/0080-1
- Physical state: liquid, colorless, clear
- Analytical purity: 100%
- Lot/batch No.: #113
- Expiration date of the lot/batch: 2011-06-13
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Animal quality: Crl:WI (Han)
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight; 175-187 g)
- Fasting period before study (only feed): 16 hours before administration
- Housing: single housing in Makrolon cages (type III)
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.73 mL/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
First step: 3 females
Second step: 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs was performed several times on the day of administration, and at least once daily thereafter each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: A check for any dead or moribund animals was made at least once each workday.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were observed during the observation period.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
Other findings:
No other findings were observed.

Any other information on results incl. tables

Table 1: Individual body weight changes of female Wistar rats.

Individual body weight changes

Administration 1

Administration 2

Dose

2000

2000

Sex

female

female

Animal number

R549

R550

R551

Mean weight

Standard deviation

R555

R556

R557

Mean weight

Standard deviation

Body weight at study day (g):

 

 

 

 

 

 

 

 

 

 

0

187

177

175

179.7

6.43

180

175

179

178.0

2.65

7

200

190

186

192.0

7.21

184

193

200

192.3

8.02

14

208

200

202

203.3

4.16

190

207

205

200.7

9.29

 

 

 

Applicant's summary and conclusion