Decanoic acid, mixed diesters with octanoic acid and triethylene glycol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 19, 1995 to October 13, 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Version / remarks:

July 1, 1991

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, mixed diesters with octanoic acid and triethylene glycol

EC Number:

271-517-9

EC Name:

Decanoic acid, mixed diesters with octanoic acid and triethylene glycol

Cas Number:

68583-52-8

Molecular formula:

C10-H20-O2.C8-H16-O2.C6-H14-O4

IUPAC Name:

Decanoic acid, mixed diesters with octanoic acid and triethylene glycol

Specific details on test material used for the study:

The test substance was received from the C.P. Hall Company on July 5, 1995. The BIN number was 024910

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Wistar-strain, albino rats were used for this test. Animals were obtained from Ace Animals, Inc., in Boyertown, PA., in equal numbers of each sex, between 200 and 300 grams bodyweight, and approximately six to nine (6 to 9) weeks of age.

Upon receipt, animals were carefully checked for respiratory difficulty, ocular or nasal lacrimation, dehydration, diarrhea, and general condition.

Animals were acclimated for eight (8) days prior to test initiation. They were housed in stainless steel cages with indirect bedding, in a room with a 12 hour light/dark cycle. The room temperature was controlled, to provide for the health and comfort of the animals with an approximate range of 65° to 75° F. The humidity was also monitored. Diet consisted of Lab Diet Certified Rodent Diet #5002, as well as water, ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Rats received a single bolus dose by oral gavage at a calculated dose of 5,000 mg/kg bw.

Doses:

A single 5,000 mg/kg bw dose was administered.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Prior to test initiation, the test article's mass to volume relationship (specific gravity) was determined to facilitate volumetric dosing.

Twenty-four (24) hours prior to test initiation, the rats were reexamined for general condition as described above. A group of five (5) male and five (5) female rats, of sufficient weight to assure a fasted bodyweight between 200 and 300 grams, was labelled and set aside.

The following day, after approximately 18 hours of fasting, each rat was weighed and marked with an ear clip. The weight variation of animals used did not exceed +20% of the mean weight for each sex. Individual doses, calculated on the basis of bodyweight, were administered using a stainless steel intragastric feeding needle, of sufficient bore to allow even passage of the test article. Rats were then returned to their cages, where food and water were available ad libitum. Each cage was labelled uniquely with respect to job number, test article, dose level, sex, animal number(s), and date of dosing.

Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post-dosage. Observations were made at least once daily thereafter for a total of 14 days. Interim bodyweights were recorded on day seven (7).

Animals sacrificed at the end of the 14 day observation period were subjected to complete gross necropsy, with all findings noted. Sacrificing was accomplished via carbon dioxide asphyxiation.

Statistics:

Not stated

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:

None recorded

Clinical signs:

other: No adverse clinical signs were reported. All rats reported as normal at all observation points.

Gross pathology:

No gross changes observed.

Any other information on results incl. tables

Acute Oral Toxicity in Rats - Bodyweights

Dose Level: 5,000 mg/kg bw

Animal Number and Sex	Bodyweight (grams)	Day 7	Termanal	Change (+/-)
1 M	230	309	344	+114
2 M	218	305	338	+120
3 M	237	307	340	+103
4 M	228	300	332	+104
5 M	233	342	384	+151
6 F	220	262	282	+62
7 F	218	251	264	+46
8 F	224	262	284	+60
9 F	246	264	270	+24
10 F	236	243	260	+24

 

Applicant's summary and conclusion

Conclusions:

The acute oral LD50 in male and female rats is > 5,000 mg/kg bw.