3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Remarks:

Acute toxicity of TegMeR 804 in rats - limit test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 18, 1992, to December 3, 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

A study conducted under Good Laboratory Practice Standards (40 CFR) and conforming with internationally recognized protocols and in particular satisfying criteria of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and OECD Guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: The protocol satisfies the criteria established by the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.

Deviations:

no

Principles of method if other than guideline:

Young adult, Sprague Dawley derived rats (male and femald) weighing between 232 and 342 grams at the start of the study were used. The undiluted test material was administered to five male and five female rats at a dose level of 5.0 g/kg.

GLP compliance:

yes (incl. QA statement)

Remarks:

All aspects of this study, as defined in the Protocol and the Project Instruction Sheet, were conducted in accordance with Good Laboratory Practice Standards (40 CFR).

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

EC Number:

242-149-6

EC Name:

3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

Cas Number:

18268-70-7

Molecular formula:

C24H46O7

IUPAC Name:

3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

Specific details on test material used for the study:

The test material was a clear, golden-yellow liquid and was stored at room temperature throughout the study in two clear, glass jars.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young, adult male and female Sprague-Dawley derived albino rats were used. Animals weighed between 232 and 342 grams at the start of the study. The animals were purchased from a U.S.D.A. approved supplier.

All animals were acclimated to the laboratory for at least four days before use. Animals were housed in groups of five (5) in wire mesh suspension cages and were supplied PURINA LABORATORY RODENT CHOW (or other comparable diet) and tap water ad libitum except for the withholding of food overnight prior to dosing. The animals were maintained in 12-hour light/12-hour dark cycles.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Each animal received the test material by gavage at a dose level of 5.0 g/kg bwt. The material was administered undiluted. Individual doses were calculated using post-fast body weights.

Doses:

All animals received a single dose of 5.0 gm/kg bwt

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

All animals were observed for gross signs of systemic toxicity and mortality several times during the day of dosing, and at least twice daily thereafter for a total of 14 days.

Body weights were measured for each animal on the day of dosing, on day 7 of the observation period, and at the time of necropsy either at the end of 14 days or following the death of any animal.

At the end of the 14-day observation period, each surviving rat was sacrificed and a gross necropsy performed.

Statistics:

Individual and mean body weights with standard deviations were determined.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality in the study.

Clinical signs:

Normal behavior was observed in all animals. Fecal staining was seen in 1 or 2 animals during the first 3 to 5 days of the observation period. Oily hair coat was observed in some or all of the animals during this same time period.

Body weight:

Body weights were not affected by the dosing.

Gross pathology:

There was no gross pathology noted.

Any other information on results incl. tables

Table 1: Body Weight Data in Male and Female Rats Treated Orally with Undiluted Test Material

Animal Number	Sex	Day 0	Day 7	Day 14	Body Weight Change (grams) Day 0 -14
1	M	340	410	441	101
2	M	294	330	361	67
3	M	320	362	380	60
4	M	342	395	419	77
5	M	305	361	383	78
Mean		320	372	397	77
Standard Deviation		21	31	32	18
6	F	256	294	304	48
7	F	232	258	269	37
8	F	237	269	277	40
9	F	263	291	305	42
10	F	271	311	314	42
Mean		252	285	294	42
Standard Deviation		17	21	20	4

Applicant's summary and conclusion

Interpretation of results:

other: Category IV - Greater than 5,000 mg/kg

Remarks:

Hazard potential as specified in 40 CFR 156.10

Conclusions:

The test material is relatively non-toxic to rats.

Executive summary:

The acute oral toxicity of the test material was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines

No deaths were noted during the observation period.

Minimal clinical changes were noted involving fecal staining and oily hair coat. These generally resolved by 3 to 5 days of observation.

There were no necropsy findings

The acute oral LD 50 value was found to be greater than 5.0 g/kg in male and female Sprague Dawley rats.