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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 425 with GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

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:

female

Details on test animals or test system and environmental conditions:

The study animals were acquired from Texas Animal Specialties; Humble, TX and weighted 182-217 gm at experimental initiation. The animals were housed in suspended stainless steel with wire bottom cages, 1 per cage. The temperature was 20-22°C and relative humidity was 32-91%. There was a 12-hour light/dark cycle and 10-12 air changes/hour in the animal room. The animals were maintained on a PMI Feeds Tnc.TM Formulab #5008 diet; available ad libitum except for approximately 16 hours before dosing. Municipal water supply analyzed by TCEQ Water Utilities Division; was available ad lib itum from automatic water system.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test substance was administered as received and was not diluted. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 1.97 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing.

Doses:

2000 mg/Kg of body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Following oral dosing 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. On Day 14 after dosing, each animal was 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:

female

Dose descriptor:

approximate LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0/5 animals

Clinical signs:

other: Clinical signs included activity decrease and piloerection. Animals were asymptomatic by Day 4.

Gross pathology:

The 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 upon the LD50 of > 2000 mg/Kg of body weight the test substance is considered to be essentially nontoxic by the oral route of exposure.

Executive summary:

The test substance, p-tert-butylphenyl-1 -(2,3)-epoxypropyl ether was accessed for acute oral toxicity in the rat by an O.E.C.D. test guidline 425 Up-Down procedure. Based upon the LD50 of > 2000 mg/Kg of body weight the test substance is considered to be essentially nontoxic by the oral route of exposure.