Mixture of mono-, di- and triesters obtained with isooctadecanoic acid and hydrogenated castor oil

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: GLP-Study according to OECD Guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (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:

Salacos HCISV-L

IUPAC Name:

Salacos HCISV-L

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

- Name of test material (as cited in study report): Salacos HCISV-L
- Substance type: organic
- Physical state: liquid
- Analytical purity: 100 % Reaction product
- Lot/batch No.: 40314
- Expiration date of the lot/batch: 02-May-2003
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: in the original container, at room temperature (17 - 23 °C), away from direct sunlight.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC ltd, Biotechnology and Animal Breeding Division, CH-4414 Füllnisdorf, Switzerland
- Age at study initiation: 8 (male) or 13 (female) weeks
- Weight at study initiation: 185.6 g - 252.2 g
- Fasting period before study: 17 - 18 hours
- Housing: in groups of three per sex
- Diet: standard ad libitum
- Water: tap water ad libitum
- Acclimation period: yes, but no times stated

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/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.
- Lot/batch no. (if required): 433337/1 20602, FLUKA
- 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:
Mortality / Viability Daily during acclimatization and twice daily during days 1-15
Body Weights on test days 1 (prior to administration), 8 and 15
Clinical signs Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administraion on test day 1. Once daily during days 2-15.


- Necropsy of survivors performed: yes, macroscopic examination
- Other examinations performed: clinical signs, body weight

Statistics:

no statistical anaylsis performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no death occured during the study

Clinical signs:

other: no clinical signs were observed

Gross pathology:

No macroscopic findings were recorded at necropsy

Other findings:

no further findings

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 Salacos HCISV-L after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight.

Executive summary:

Three male and three femal HanBrl: WIST (SPF) rats were treated with Salacos HCISV-L by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume dosage of 20 ml/kg.

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

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.