Benzene, 1-(decyloxy)-2-(1-methylpropyl)-4-(triphenylmethyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

XU-18838.00

Cas Number:

1391350-92-7

IUPAC Name:

XU-18838.00

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): XU-18838.00
- Physical state: solid
- Lot/batch No.: 20120135-18
- Expiration date of the lot/batch: 02 April 2013
- Storage condition of test material: Ambient

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, Inc., Frederick, MD
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 142-168 grams
- Fasting period before study: overnight
- Housing: The animals were singly housed in suspended stainless steel caging with
mesh floors
- Diet (e.g. ad libitum): Harlan Teklad Certified Global 16% Protein Rodent Diet® #2016C. The diet
was available ad libitum
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing
system.
- Acclimation period: 21-29 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23ºC
- Humidity (%): 42-70%
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

IN-LIFE DATES: May 7-31, 2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% w/w mixture in corn oil

Doses:

2000 mkd

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights of the animals were recorded prior to test substance administration
(initial) and again on Days 7 and 14 (termination) following dosing. The animals were observed for mortality, signs of gross toxicity, and behavioral changes
during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: Gross
necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal
cavities, and the stomach and its contents were examined.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived test substance administration, and the 14-day observation period.

Clinical signs:

other: All animals appeared active and healthy during the study. There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.

Gross pathology:

No gross abnormalities were noted for any of the animals when necropsied at
the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral LD50 of XU-18838.00 is greater than 2,000
milligrams per kilogram of body weight in female rats.

Executive summary:

An acute oral toxicity test (Up and Down Procedure) was conducted with female Fischer 344 rats to determine the potential for XU-18838.00 to produce toxicity from a single dose via the oral route. Under the conditions of this study, the acute oral LD50 of the test substance is greater than 2,000 mg/kg of body weight in female rats. An initial limit dose of 2,000 mg/kg was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, four additional females sequentially received the same dose level. Since these animals survived, no additional animals were tested. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing. Necropsies were performed on all animals at terminal sacrifice. All animals survived test substance administration, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.