Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guidline Study performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid

EC Number:

942-166-5

Cas Number:

922708-02-9

Molecular formula:

not applicable

IUPAC Name:

Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid

Constituent 2

Reference substance name:

Glyceryl Behenate/isostearate/eicosadioate

IUPAC Name:

Glyceryl Behenate/isostearate/eicosadioate

Test material form:

solid: pellets

Details on test material:

- Name of test material (as cited in study report): Nomcort SG
- Substance type: organic
- Physical state: solid
- Analytical purity: not stated
- Lot/batch No.: L060725
- Expiration date of the lot/batch: Jul 25, 2009
- Stability under test conditions: not stated
- Storage condition of test material: room temperature, air tight

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: OrientBio Inc. 143-1 Sangdaewon-dong, Joongwon-gu, Seongnam-si, Gyonggi-do, Korea
- Age at study initiation: 8-9 week
- Weight at study initiation: 163.4 - 186.4 g
- Fasting period before study: 16 h
- Housing: individual
- Diet: standard ad libitum
- Water: filtered and sterilized drinking water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 23.1
- Humidity (%): 38.1 - 56.5
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 60 g/l (300 mg/kg bw) or 400 g/l (2000 mg/kg bw)
- Amount of vehicle (if gavage): 5 ml/kg
- Justification for choice of vehicle: according to the sponsors information and preliminary test, olive oil was selected since the test substance was dissolved into olive oil.
- Lot/batch no. (if required): 115K6046

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:as no information was present, the starting dose was selected according to OECD Guideline 423.

Doses:

300 mg/kg bw, 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: clinical signs: once per day, body weight: before dosing, on day 3, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no statistics performed

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed, all animals survived to the scheduled termination

Clinical signs:

other: no abnormal clinical signs

Gross pathology:

no macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 established in the present Study according to Guideline OECD 423 is
LD50 > 2000 mg/kg bw.
Therefore the substance has not to be treated as toxic after single dose via oral route and has not to be classified.

Executive summary:

This study was performed to evaluate the acute toxicity and LD50 for a single oral administartion of Nomcort SG in rats. In step 1 and 2 of 300 mg/kg and in step 3 and 4 of 2000 mg/kf of the test substance were administered orally into 3 female rats per each step. Clinical signs and body weight changes were observed for 14 days after the administration and gross findings at the necropsy were observed on day 14.

Throughout the treatment from step 1 to step 4, there were no tratment-related differences noted in the body weight data and mortality.

Throughout the treatment from step 1 to step 4, there were no abnormal clinical signs during the observation perios.

In the necropsy, there were no macroscopic abnormalities in all animals in step 1, 2, 3 and 4.

In conlusiont, the test substance Nomcort SG in relation to the acute oral administration was classified as unclassified. In addition, LD50 range was considered to be LD50 > 2000 mg/kg bw.