Glycerol, ethoxylated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay, Labor für biologische Analytik GmbH, 69120 Heidelberg

Test type:

standard acute 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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Crl:WI (Han) rats from Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males approx. 8 weeks; females approx. 12 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

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: about 40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze and stretch bandage (Fixomull® Stretch (adhesive fleece))

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 5000 mg/kg bw (4.31 mL/kg bw)

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex

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. Individual skin readings were performed 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and on the last day of observation.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals after sacrifice 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 male Wistar rats.

Individual body weight changes
Dose	5000
Sex	male
Animal number	R479	R480	R481	R482	R483	Mean weight	Standard deviation
Body weight at study day (g):
0	226	235	245	240	235	236.2	7.05
7	243	259	285	272	269	265.6	15.68
14	271	289	323	301	304	297.6	19.23

 

Table 2: Individual body weight changes of female Wistar rats.

Individual body weight changes
Dose	5000
Sex	female
Animal number	R484	R485	R486	R487	R488	Mean weight	Standard deviation
Body weight at study day (g):
0	207	208	211	201	201	205.6	4.45
7	210	208	211	207	201	207.4	3.91
14	215	218	222	216	207	215.6	5.50