Glycerol, ethoxylated

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

Alkoxylation reaction product of glycerin as starter and ethylene oxyde (EO) as monomer

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:

other: No clinical signs were observed during the observation period.

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