2,2'-dimorpholinyldiethyl ether

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not indicated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Well documented non-GLP study performed according to a guideline similar to OECD Guideline 401. Only two animals per sex per dose level are used (instead of 5).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Only 2 animals per sex per dose level are used instead of 5.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-dimorpholinyldiethyl ether

EC Number:

229-194-7

EC Name:

2,2'-dimorpholinyldiethyl ether

Cas Number:

6425-39-4

Molecular formula:

C12H24N2O3

IUPAC Name:

4-{2-[2-(morpholin-4-yl)ethoxy]ethyl}morpholine

Test material form:

liquid

Details on test material:

- State of aggregation : liquid
- Appearance : colourless to yellow brown

Specific details on test material used for the study:

OTHER SPECIFICS:
- Name of test material (as cited in study report): Aus 0213 4236-14-4 Alkaline Corrosive Liquid N2 Pad Urethane Catalyst
- Appearance: orange liquid

Test animals

Species:

rat

Strain:

other: Crl:COBS CD (SD) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Young albino rats: Charles River CD Strain, Crl:COBS CD (SD) BR
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts 01887
- Age at study initiation: young rats
- Weight at study initiation: males 180-232 g (mean 205.2 g); females 164-220 g (mean 194.8 g)
- Fasting period before study: 24 hours before oral intubation
- Housing: Animals were housed in suspended, wire-mesh stock cages
- Diet (e.g. ad libitum): permitted a standard laboratory diet: Purina Rat Chow 5012, Ralstor, Purina Company, St. Louis, Missouri 63188 (ad libitum)
- Water (e.g. ad libitum): water was permitted ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

or undiluted

Details on oral exposure:

Form administered: As a 10.0% (w/v) aqueous solution at 118.5-400,0 mg/kg and undiluted at 1350 - 4556 mg/kg.
Selected groups of albino rats were administered test material at several dose levels. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.

Doses:

118,5; 400; 1350; 2025; 3038; 4556 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

After oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages and observed for the following 14 days. Initial and final body weights, mortalities and reactions were recorded. A necropsy examination was conducted on all animals.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 025 mg/kg bw

Based on:

test mat.

Remarks on result:

other: SD = +/- 237.6 mg/kg

Mortality:

118,5 mg/kg group: 0 /4 dead
400 mg/kg group: 0/4 dead
1350 mg/kg group: 0/4 dead
2025 mg/kg group: 2/4 dead (1 female between 6-22h and 1 female after 1.5 days)
3038 mg/kg group: 4/4 dead (1 male and 1 female between 6-22h, 1 male after 1 day, 1 female after 2 days)
4556 mg/kg group: 4/4 dead (2 males after 4.5 days, 2 females between 6-22h)

Clinical signs:

other: Diuresis was observed in the 4556 mg/kg dose group in 2 animals. Hypoactivity, hyperirritability, lacrimation and tremors were observed in the 2025 and 3038 mg/kg dose group. Hemorrhagic lacrimation was observed in the 2025 mg/kg dose group in 1 animal. L

Gross pathology:

At 2025 mg/kg bw moderate postmortem autolysis was observed in 2 females
At 3038 mg/kg bw moderate postmortem autolysis was observed in one male and one female and slightly pale spleen was observed in one male
At 4556 mg/kg bw moderate postmortem autolysis was observed in two females and advanced postmortem autolysis was observed in two males.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

In this study an acute oral LD50 value of 2025 mg/kg bw was determined in rats after exposure to the substance. Therefore, the substance is considered not to be classified according to CLP.