[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.03.2007 - 27.03.2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Study according to OECD Guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

Directive 2004/73/EC, B.1 tris

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glyceryl Behenate/eicosandioate

IUPAC Name:

Glyceryl Behenate/eicosandioate

Constituent 2

Reference substance name:

-

EC Number:

478-910-6

EC Name:

-

Cas Number:

215322-01-3

Molecular formula:

C114H218O12 for the stoichiometric product

IUPAC Name:

Reaction product of Eicosanedioic acid, Docosanoic acid and Glycerin

Test material form:

solid: pellets

Details on test material:

- Name of test material (as cited in study report): Nomcort HKG
- Substance type: organic
- Physical state: solid
- Analytical purity: 100 %
- Lot/batch No.: 5-11-B
- Expiration date of the lot/batch: 29.04.2007
- Stability of test material: stable under storage condition
- Storage condition of test material: at room temperature (range of 20 +- 5 °C) away from direct sunlight

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH4414 Füllinsdorf, Switzerland
- Age at study initiation: 11 weaks
- Weight at study initiation: 175.7 - 205.8 g
- Fasting period before study: 18 hours
- Housing: in groups of 3 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: duration not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. Corn oil was found to be asuitable vehicle
- Lot/batch no. (if required): 27572782
- Purity: not stated

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not stated

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for clinical signs daily, for mortality/viability twice daily and body weights weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no staticitcal analysis was used

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occured during the study.

Clinical signs:

other: No signs of toxicity were observed. Mortality: No death occurred during the study. Clinical Signs: No clinical Signs were observed during the course of the study. Body Weights: The body weight of the animals was within the range co

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of Nomcort HK-G after single oral administration to female rats, observed over a period of 14 days is Ld50 greater than 2000 mg/kg body weight.

Executive summary:

Two groups, each of three female Wistar rats, were treated with Nomcort HK-G by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (corn oil) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.

The animals were examined dily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once dily during test days 2 - 15. Mortality/viability was recorded during the first 30 minutes and at approximately, 1, 2, 3 and 5 hours after administration on test day 1 (with clinical signs) and twice daily during days 2 - 15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.