Decanoic acid, mixed diesters with octanoic acid and triethylene glycol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Remarks:

Acute toxicity of TegMeR 804 in rabbits

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 18, 1992, to December 15, 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 Ro denticide 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, male and female New Zealand White rabbits weighing between 2064 grams to 2467 grams at the start of the study were used. The test material was administered as received at a limit dose of 20 g/kg bw.

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult male and female New Zealand White rabbits were used. Animals weighed between 2064 and 2467 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 singly in wire mesh suspension cages and were supplied PURINA LABORATORY RABBIT 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Shortly prior to dosing, the hair of each rabbit was closely clipped from the ventral surface of the trunk using an electric clipper so as to expose approximately 10% of the body surface area.

Animals were weighed shortly before test material exposure in order to calculate doses. The test material was applied to sleeves of rubber dental dam. Each sleeve was wrapped around the trunk of the respective animal and secured with staples. An outer layer of gauze was then wrapped around the trunk of each aniaml and secured with tape. Each rabbit was then fitted with a colar to prohibit removal of the wrapping.

At the end of a 24-hour exposure period, the wrapping was removed and any unabsorbed test material remaining on the skin was removed by gently sponging using a moistened towel. The presence or absence of any residual test material was documented.

Duration of exposure:

24 hours

Doses:

All animals received a single dermal application of 20 gm/kg bwt.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

All animals were observed for signs of toxicity and behavioral changes once, or more frequently if clinical signs were present, on the day of treatment. All surviving rabbits were then maintained for 14 days following completion of the exposure period. An examination for gross signs of toxicity were carried out once daily with additioinal checks for viability during the day. Skin reactions and other evidence of injury including erythema, edema, atonia, desquamaation, necrosis, coriaceousness and fissuring were noted if present.

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:

other: A limit dose was administered

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There was no mortality in the study.

Clinical signs:

other: Mild to marked erythema and edema were observed in all animals and generally decreasing in severity at the end of the 14-day observation period. Mild to marked desqamation was observed in all animals generally in the last 4 or 5 days of the 14-day observa

Gross pathology:

There was no gross pathology noted.

Any other information on results incl. tables

Table 1: Body Weight Data in Male and Female Rabbits Treated Dermally with Undiluted Test Material at a Dose Level of 20 g/kg

Animal Number	Sex	Day 0	Day 7	Day 14	Body Weight Change (grams) Day 0 -14
1	M	2084	2206 (1)	2331	267
2	M	2335	2363 (1)	2471	136
3	M	2301	2260 (1)	2343	42
4	M	2326	1621	2454	128
5	M	2258	1548	2364	106
Mean		2257	2000	2393	136
Standard Deviation		112	384	65	82
6	F	2346	2437 (1)	2457	111
7	F	2336	2555 (1)	2524	188
8	F	2408	2609 (1)	2806	398
9	F	2233	2236 (1)	2259	26
10	F	2238	2230 (1)	2361	113
Mean		2312	2413	2479	167
Standard Deviation		75	176	209	141

(1) Day 7 body weights taken with collars on.

Applicant's summary and conclusion

Interpretation of results:

other: Category IV - Greater than 20,000 mg/kg Hazard potential as specified in 40 CFR 156.10

Conclusions:

The test material is relatively non-toxic to rabbits.

Executive summary:

The acute dermal 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.

There were no necrospsy findings.

The acute dermal LD 50 value was found to be greater than 20 g/kg in male and female New Zealand White rabbits.