(ethylenedioxy)dimethanol

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:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(ethylenedioxy)dimethanol

EC Number:

222-720-6

EC Name:

(ethylenedioxy)dimethanol

Cas Number:

3586-55-8

Molecular formula:

No exact molecular formula can be given for a complex reaction mixture (UVCB substance).

IUPAC Name:

[2-(hydroxymethoxy)ethoxy]methanol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Bi-distilled water.

Details on oral exposure:

Concentration in vehicle: 0.2 g/mL or 0.02 g/mL
Total volume applied: 10 mL/kg bw

Doses:

3 females dosed at 2000 mg/kg bw; 3 females dosed at 200 mg/kg bw; 3 males dosed at 200 mg/kg bw.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

All animals were fasted sixteen to twenty hours before dosing and three hours after dosing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 200 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

3 f at 2000, 0 f+m at 200 mg/kg dw

Clinical signs:

other: In females administered 2000 mg/kg bw, ventral recumbency and marked sedation were observed in one animal during the first hour after treatment. This animal died two hours after treatment. A second animal showed slight sedation during the first two hours

Gross pathology:

Females at 2000 mg/kg bw: Animals that died in the first and fifth hour showed distended stomach and black-brown contents of jejunum. The animal found dead on the second day showed distended stomach.
Females and males at 200 mg/kg bw: No macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 for both males and females was between 200 and 2000 mg/kg bw.

Executive summary:

The test substance was administered once by gavage to three groups of three rats each following approximately 16 to 20 hours of fasting. Dose levels were 2000 mg/kg bw and 200 mg/kg/bw to females and 200 mg/kg bw to males, all in 10 mL/kg bw. Clinical observations were made 1, 2, 3, and 5 hours after dosing and daily thereafter until termination on Day 15. Bodyweights were recorded on days 1, 8, and 15. Gross necropsies were performed on all animals.

All animals died at 2000 mg/kg bw, no mortality was observed at 200 mg/kg bw.