2,6,10-Trimethyldodecane (Farnesane)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6,10-trimethyldodecane

EC Number:

622-542-2

Cas Number:

3891-98-3

Molecular formula:

C15H32

IUPAC Name:

2,6,10-trimethyldodecane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Farnesane
- CAS number: 3891-98-3
-Specific Gravity: 0.77 g/cm3 at 15 °C

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were received from Covance Research Products, Inc., Denver, PA on 08/11/10. Following an acclimation period of at least five days, five healthy male and five healthy, non-pregnant and nulliparous female New Zealand White rabbits were randomly assigned to the treatment group.

TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA

- Age at study initiation: The animals were born on 05/01/10. First Exposure was 8/18/10

- Weight at study initiation: The pretest body weight range was 2.1 - 2.9 kg for males and
2.2 - 2.5 kg for females. The weight variation of the animals used did not exceed + 20% of the mean weight.

- Housing: The animals were identified by cage notation and a uniquely numbered metal eartag and housed 1/cage in suspended wire cages. Paper bedding was placed beneath the cages and changed at least three times/week. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily.

- Water (e.g. ad libitum): Ad libitum

- Acclimation period: At least 5 days

IN-LIFE DATES: From: 8/18/10 To: 9/1/10

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Site Preparation
The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact.

Dosing
A single dose of the test article was applied to the prepared site, over a 4-ply porous gauze dressing measuring 10 x 15 cm at a dose level of 5000 mg/kg. The dose was based on the sample weight as calculated from the specific gravity. The torso was wrapped with plastic sheeting in a semi-occlusive manner, which was secured with non-irritating tape. The test article remained in contact with the skin for 24 hours at which time the wrappings were removed. Residual test article was removed by gently washing with distilled water.

- Amount(s) applied (volume or weight with unit) are summarzed below in "Results and Discussion" table

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 males at 5000 mg/kg and 5 females at 5000 mg/kg

Control animals:

not required

Details on study design:

Five healthy male and five healthy female New Zealand White rabbits were dosed dermally with Farnesane CAS# 3891-98-3, Lot# AMD_072010 at 5000 mg/kg of body weight. The test article was kept in contact with the skin for 24 hours. Dermal responses were recorded at 24 hours postdose and on days 7 and 14. Animals were observed for toxicity, mortality and pharmacological effects at 1, 2 and 4 hours postdose and once daily for 14 days. Body weights were recorded pretest, weekly and at termination. All animals were examined for gross pathology.

Statistics:

Body weight data is summarized in "Results and Discussion"

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:

0/10

Clinical signs:

other: One male and one female were noted with soiling of the anogenital area between days 1 and 3. There were no other abnormal physical signs noted during the observation period. Skin reactions were absent to well defined for erythema and absent to slight f

Gross pathology:

Necropsy results were normal.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Dermal LD50 in rabbits > 5000 mg/Kg

Executive summary:

Objective: To determine the potential for toxicity of the test article when applied dermally. This study was designed to comply with the standards set forth in EPA Health Effects Testing Guidelines, OPPTS 870.1200, final guideline, August 1998.

 

Method Synopsis: Five healthy male and five healthy female New Zealand White rabbits were dosed dermally with farnesane CAS# 3891-98-3 at 5000 mg/Kg of body weight. The test article was kept in contact with the skin for 24 hours. Dermal responses were recorded at 24 hours post-dose and on days 7 and 14. Animals were observed for toxicity, mortality and pharmacological effects at 1, 2 and 4 hours postdose and once daily for 14 days. Body weights were recorded pretest, weekly and at termination. All animals were examined for gross pathology. 

 

Summary: All animals survived the 5000 mg/Kg dermal application.

 

One male and one female were noted with soiling of the anogenital area between days 1 and 3. There were no other abnormal physical signs noted during the observation period.

 

Skin reactions were absent to well defined for erythema and absent to slight for edema at 24 hours. On day 7, flaking skin was noted in one animal and no other skin reactions were noted. On day 14, skin reactions were absent.

 

Body weight changes were normal.

 

Necropsy results were normal.

 

Conclusion: The dermal LD₅₀ of Farnesane CAS# 3891-98-3 is greater than 5000 mg/Kg of body weight.