Soybean oil, reaction products with ethaneperoxoic 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: GLP/guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, reaction products with ethaneperoxoic acid

Cas Number:

693217-63-9

Molecular formula:

C59 H106 O11

IUPAC Name:

Soybean oil, reaction products with ethaneperoxoic acid

Test material form:

liquid: viscous

Details on test material:

The test material, Agrol Polyol, a hydroxylated soybean oil was 99.9% pure

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Source: Charles River Canada, Montreal, Quebec
Number and Sex: 6 female rats were used.
Body Weight Range: 204.5 - 226.5 g after fasting. The weight variation in animals at the start of the study did not exceed :::I:: 20 percent of the mean weight.
Acclimatization Period: 7 days
Age at Study Start: Approximately 10 weeks

Animal Housing and Maintenance:
Female rats were individually housed in separate quarters in solid bottom cages. Individual animals were identified by colour coding, the animal number and group number also appeared on the outside of each cage to preclude mix-up. The animal room environment was controlled (targeted ranges: temperature 19C to 25C, relative humidity 30-70%) and monitored daily. The photo-cycle was 12 hours light and 12 hours dark. Upon arrival all animals were submitted to a general physical examination and all were found healthy and were admitted. Teklad Certified Rodent Diet and water were offered ad libitum throughout the acclimatization and study periods. The cage cleaning schedule, air filtration and recirculation, health checks and facility maintenance were carried out in accordance with the applicable Nucro-Technics' Standard Operating Procedures, and such activities were recorded in the animal room records.

Animals were housed and maintained according to the AAALAC International Guide for the Care and Use of Laboratory Animals, CCAC Guidelines for Care and Use of Experimental Animals and Nucro-Technics' Standard Operating Procedures.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals were dosed at 2000 mg/kg (2.1 mL/kg by volume). The individual doses of the test article were individually calculated for each animal based on the body weight of the animal, All doses were administered orally using a feeding cannula, inserted into the stomach of the animals. After dose administration, food was withheld for a further 3 hours.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

not specified

Details on study design:

Animal Selection/Randomization:
The test population of animals was selected from newly arrived, previously unused rats. The method of randomization was based upon the random selection of numbers generated from a set of numbers without replacement.

Preparation of Animals:
All animals used for the Limit Test were fasted over-night. Food but not water was withheld from 4:30 p.m. on the day preceding dosing. Animals were fed approximately 3 hours after dosing.

Limit Test:
The chemical composition indicated that the test article was likely to be non-toxic, therefore, a decision was made to proceed with the Limit Test.

The first group of 3 animals were dosed at 2000 mg/kg. Since these animals survived, the second group of 3 animals were dosed 3 days later. A total of six animals were tested.

Test Article Preparation:
The test article was dosed "as is". The specific gravity of the test article of 0.97 was taken into account for the dose volume calculation.

Observations Durin In-Life Phase:
The animals were individually observed once during the first 30 minutes after dosing and periodically during the first 24 hours following dosing (with special attention given during the first 4 hours). Observations twice daily were carried out for the remainder of the study and were recorded at least once a day. The animals were observed for 14 days after the dosing. Cageside observations were directed towards any changes in the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to any observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and/or coma. Observations were recorded daily for the entire study period using the In-Life Module V.6.1, and the entries were monitored by the Study Director. The body weights of the animals were determined prior to test article administration (i.e., Day 0), on Day 7 and on Day 14. Body weight gains were calculated.

Post Mortem Examination:
Gross necropsy was performed on each rat at the end of the 14-day observation period and necropsy included an examination of: external surfaces of the body; all orifices; cranial cavity; external surfaces of the brain and spinal cord; nasal cavity and paranasal sinuses; thoracic, abdominal, and pelvic cavities and viscera.

Statistics:

No additional information available.

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: Highest dose tested.

Mortality:

No effect on mortality was observed post dosing and during the 14-day observation period in any of the 6 animals.

Clinical signs:

other: No effect on toxicity was observed post dosing and during the 14-day observation period in any of the 6 animals.

Gross pathology:

Each animal was sacrificed at the end of the 14-day observation period and full gross necropsy was performed. No gross pathological findings were observed at the time of necropsy

Other findings:

No additional information available.

Any other information on results incl. tables

Table 1: Body Weight Summary

Mean-Group Weight (g) + S.D. (g); n = 3				Mean Weight Gain (g); n = 3
Group	Initial	Day 7	Day 14	Days 0 to 14
1	209.4 + 7.4	241.6 + 10.2	255.4 + 16.4	46.0 + 20.4
2	216.9 + 10.6	251.9 + 12.5	255.7 + 13.2	38.8 + 8.6

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Based on the foregoing results, the acute oral LDso in rats of the test article, Agrol Polyol was found to be in excess of 2000 mg/kg. Therefore, the test article is considered not to present a significant acute toxic risk if swallowed.
 

Executive summary:

An acute oral toxicity study in rats of the test article, Agrol@ Polyol, was carried out at Nucro-Technics according to Protocol No. ISI/227824 and OECD guideline #423.

 

Since the test article was a liquid, it was dosed "as is". The specific gravity of the test article of 0.97 was taken into account for the dose volume calculation.

 

The first group of 3 animals were dosed at 2000 mg/kg (2.1 mL/kg by volume of test article). Since this first group of animals survived, the second group of 3 animals were dosed 3 days later. A total of 6 female Sprague-Dawley rats were dosed. All animals received the test article by oral gavage using a feeding cannula.

 

No effects of toxicity or mortalities were observed post dosing and during the l4-day observation period in any of the animals. All six rats gained body weight by Day 7 and at the end of the study. At the end of the 14-day observation period, each animal was sacrificed and submitted for gross necropsy. No gross pathological findings were observed in any rat at necropsy.

 

Based on the foregoing results, the acute oral LD5o in rats of the test article, Agrol Polyol was found to be in excess of 2000 mg/kg. Therefore, the test article is considered not to present a significant acute toxic risk if swallowed.

 

The Globally Harmonized System of Classification and Labelling of Chemicals classifies compounds in which the estimated LDso is greater than 2000 mg/kg with no deaths or evidence of toxicity as being Category 5 chemicals.