1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Dec 2008 to 9 Mar 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 17th December 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate

Molecular formula:

C19H36O6

IUPAC Name:

1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate

Test animals

Species:

rat

Strain:

other: Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: 197 - 204 g
- Fasting period before study: 16 h
- Housing: two animals per cage during the quarantine/acclimation period, afterwards one animal per cage in bracket-type stainless-steel wire mesh cages
- Diet: pelleted diet CRF-1 (Oriental Yeast Co., Ltd., Lot No.: 080904), ad libitum (4 h after exposure)
- Water: tap water ad libitum
- Acclimation period: approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: December 24, 2008 (first step), December 26, 2008 (second step) To: January 7, 2009 (first step), January 9, 2009 (second step)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Lot/batch no.: PEM1838 (Wako Pure Chemical Industries Ltd.)

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Since the acute oral toxicity of the test article was expected to be extremely low, the starting dose level was set at 2000 mg/kg bw.

Doses:

2000 mg/kg bw (first and second step)

No. of animals per sex per dose:

first step: 3females
second step: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality, clinical signs, external appearance, nutritional condition, posture, behavior and excrement were recorded first 6 h after administration (from immediately to 5 min, up to 15 min, 30 min, 1 h, 2 h, 4 h and 6 h after administration), and then once daily for 14 days. Body weight was measured on day 0 (immidiately before dosing) and on days 1, 3, 7 and 14 after administration.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology

Statistics:

Mean values and standard errors were calculated.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Animals sacrificed at the end of the post-treatment observation period showed no evidence of test-substance related grossly visible organ lesions.

Any other information on results incl. tables

Table 1: Summary acute oral toxicity in rats

Dose step	Dose level (mg/kg)	Dose concentration (mg/mL)	Dose volume (mL/kg body weight)	Sex	Number of animals	Clinical signs/Mortality
First	2000	400	5	Female	3	0/0/3
Second	2000	400	5	Female	3	0/0/3

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

In this acute oral toxicity study performed in rats a LD50 value of > 2000 mg/kg bw was determined.