Bis(2-chloroethyl) ether

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1948

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1944

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Range Finding Test of Smyth and Carpenter (1944)

Principles of method if other than guideline:

- Principle of test: standard acute test discribed in Smyth & Carpenter (1944), The place of the range finding test in the industrial toxicology laboratory. J. Ind. Hyg. Toxicol. 26, 269-273 and subsequent updates

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-chloroethyl) ether

EC Number:

203-870-1

EC Name:

Bis(2-chloroethyl) ether

Cas Number:

111-44-4

Molecular formula:

C4H8Cl2O

IUPAC Name:

1-chloro-2-(2-chloroethoxy)ethane

Test material form:

liquid

Specific details on test material used for the study:

TEST MATERIAL
Name of test material (as cited): Dichloroethyl ether
Purity: not specified

Test animals

Species:

rat

Strain:

Sherman

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

10, 100, 1000, 10000 mg/kg bw etc.

No. of animals per sex per dose:

6

Details on study design:

Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No data available
- Other examinations performed: Mortality
Other details:
6 male Sherman strain rats are given a single dose by stomach tube of 10, 1, 0.1, etc. g/kg body weight. One week later six more animals are given some other dosage and this procedure is repeated until two dosages differing by a multiple of ten are found, one of which within fourteen days kills some or all animals and the other of which kills some or no animals. An LD50 is then estimated on the assumption that the slope of a probit mortality vs. log dosage curve is the same as that of some structurally similar material which has been studied in more details previously.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

75 mg/kg bw

Based on:

test mat.

Clinical signs:

other: No data

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Following the oral (gavage) exposure of groups of 6 Sherman rats at 10, 100, 1000, 10000 mg/kg bw, the LD50 value obtained for Bis(2-chloroethyl) ether in rat by oral route is 75 mg/kg. This data classifies the substance in the Acute Category III according to GHS criteria.

Executive summary:

In this pre-GLP study, groups of 6 Sherman rats were exposed to Bis(2-chloroethyl) ether through the orale route (gavage) at 10, 100, 1000, 10000 mg/kg bw. The methodology used is derived from the Range Finding method of Smyth and Carpenter (1944). Mortality of test animals was monitored for 14 days post-exposure. No clinical observations, body weight measurements or necropsy data are reported in the original publication.

The rat LD50 of Bis(2-chloroethyl) ether following single exposure by the oral route was found to be 75 mg/kg bw. Despite the lack of detailed observation following exposure to the substance, the data were generated based on a standardised method and has been peer-reviewed.