2,2'-isopropylidenebis(p-phenyleneoxy)diethanol

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-isopropylidenebis(p-phenyleneoxy)diethanol

EC Number:

212-985-6

EC Name:

2,2'-isopropylidenebis(p-phenyleneoxy)diethanol

Cas Number:

901-44-0

Molecular formula:

C19H24O4

IUPAC Name:

2,2'-isopropylidenebis(p-phenyleneoxy)diethanol

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

At the start of the main study, the males weighed 154 - 180 g, and the females 126 - 136 g, were approximately five to eight weeks old.
The animal room was maintained at a temperature of 19 - 22°C and relatve humidity of 46 - 58%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Exposure period of 14 days

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Preliminary study:

A range-finding study was conducted using 1 female and 1 male rats to establish the dose regime. The dose level was 2000 mg/kg, the concentration was 200 mg/ml and the dose volume was 10 mg/kg. Overt signs or deaths were observed 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days. There were no deaths or clinical signs of toxicity. Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was recorded.

Clinical signs:

other: Common signs of hunched posture were noted with additional signs of ataxia, lethargy and decreased respiratory rate. Animals recovered one day after dosing except for two males which appeared normal throughout the study.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be > 2000 mg/kg bodyweight.

Executive summary:

The acute oral toxicity of the test substance to Sprague-Dawley rats was determined in accordance with the OECD Guideline for Testing of Chemicals 401. The rats were exposed to a dose of 2000 mg/kg bw of the test substance via oral gavage route. No mortality was observed and the acute oral median lethal dose (LD50) of the test material was found to be > 2000 mg/kg bodyweight. The test substance is not classified for acute oral toxicity.