p-tert-butylphenyl 1-(2,3-epoxy)propyl ether

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: The study was conducted according to the O.E.C.D. test guideline 402 with GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

p-tert-butylphenyl 1-(2,3-epoxy)propyl ether

EC Number:

221-453-2

EC Name:

p-tert-butylphenyl 1-(2,3-epoxy)propyl ether

Cas Number:

3101-60-8

Molecular formula:

C13H18O2

IUPAC Name:

2-[(4-tert-butylphenoxy)methyl]oxirane

Constituent 2

Reference substance name:

p-tert-butylphenyl-1-(2,3)-epoxypropyl ether

IUPAC Name:

p-tert-butylphenyl-1-(2,3)-epoxypropyl ether

Constituent 3

Reference substance name:

Oxirane, 2-((4-(1,1-dimethylethyl)phenoxy)methyl)

IUPAC Name:

Oxirane, 2-((4-(1,1-dimethylethyl)phenoxy)methyl)

Test material form:

other: Liquid at room temperature.

Details on test material:

As per IUCLID5 Sections 1.1. 1.2. and 4.1.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Study animals were acquired from Texas Animal Specialties; Humble, TX and the males weighted 248-271 gm and the females weighted 175-189 gmon the day of dosing. The animals were housed in suspended stainless steel with wire bottom cages, 1 per cage. The temperature range in the animal room was 20-22°C and the relative humidity was 34-91%. During the study the animal room was operated on a 12-hour light/dark cycle with 10-12 air changes/hour. The animals were maintained PMI Feeds Inc.TM Forinulab #5008 diet; available ad libitum and municipal water supply analyzed by TCEQ Water Utilities Division; tap water, available ad libitum (automatic system).

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Each animal was prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose not less than 10% of the total body surface area. Care was taken to avoid abrading the skin. Only those animals with exposure areas free of pre-existing skin irritation or defects were used for this study. All animals were treated with approximately 2000 mg/kg (2.0 mL/kg) of undiluted test substance. An individual dose was calculated for each animal based on its Day 0 body weight just before exposure. The test substance was applied evenly to each exposure area in a thin, uniform layer. The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each animal was then wrapped with a veterinary flexible cohesive bandage (semi-occlusive), secured in place with non-irritating adhesive tape to preveit possile ingestion of the test substance.

Duration of exposure:

24 hr

Doses:

Approximately 2000 mg/Kg of body weight.

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

Following the exposure period of 24 hr the wrappings were removed from the trunk of the animals. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible.

Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14. Observations for evidence of dermal irritation were made at approximately 60 minutes after removal of wrappings, and on Days 4, 7, 11 and 14.

On Day 14 after dosing, surviving animals were euthanized by an overdose of CO2. All study animals, were subjected to gross necropsy and all abnormalities were recorded.

Statistics:

None required.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Based on results from ten animals.

Mortality:

There was no mortality during the study.

Clinical signs:

other: All animals appeared normal for the duration of the 14-day study. There were no signs of dermal irritation at any observation during the study.

Gross pathology:

Gross necropsy conducted at termination of the study revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the acute dermal LD50 of > 2000 mg/Kg of body weight the test substance is essentially nontoxic to the rat. Furthermore, the test substance is not irritating to the skin under the conditions of the study.

Executive summary:

The test substance, p-tert-butylphenyl-1 -(2,3 -epoxy)propyl ether was evaluated for potential acute dermal toxicity to the rat in an O.E.C.D. test guideline no. 402 study. Based on the acute dermal LD50 of > 2000 mg/Kg of body weight the test substance is essentially nontoxic to the rat by dermal exposure. Furthermore, the test substance is not irritating to the skin under the conditions of the study.