Diisopropyl ether

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

-Observed for up to 7 days after dosing

Principles of method if other than guideline:

16 solvents administered orally (via syringe) to newborn, immature, young adult, and older adult rats. LD50 values were calculated by the method of Litchfield and Wilcoxon (1949).

GLP compliance:

no

Remarks:

Study pre-dates GLP requirements.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Isopropyl ether
- Physical state: Liquid
- Analytical purity: Commercial solvents, analytical grade

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Four different ages were tested - 24 to 48-hour old (newborn rats); 14-day old (immature rats); age not reported for young adults and older adults.
- Weight at study initiation: 5 to 8 g (newborn rats); 16 to 50 g (immature rats); 80 to 160 g (young adults); 300 to 470 g (older adults).
- Fasting period before study: Non-fasted rats were used.

Administration / exposure

Route of administration:

other: Orally via straight needle or microsyringe

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: Not reported

Doses:

Not reported

No. of animals per sex per dose:

-6 to 12 mixed sex animals per study in newborn and immature 14-day old rats
-6 male animals per study on young and older adults

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: No

Statistics:

The LD50 and associated confidence limits were calculated both by the method of Litchfield and Wilcoxon (1949) and by a probit analysis statistical program via an IBM-1800 calculator. Parallel probit analyses (Finney, 1952), programmed for the IBM-1800 computer, were carried out on the LD50 values to compare the potencies within the 3 to 4 age groups for each of the solvents tested.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

6.4 mL/kg bw

95% CL:

4.7 - 8.6

Remarks on result:

other: 14-day old

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

16.5 mL/kg bw

95% CL:

15.3 - 17.7

Remarks on result:

other: young adult

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

16 mL/kg bw

95% CL:

14.1 - 18.4

Remarks on result:

other: older adult

Mortality:

No information available

Clinical signs:

other: No information available

Gross pathology:

No information available

Other findings:

- Other observations: Able to obtain only a rough approximation of the acute oral LD50 values for newborn rats due to minimum administration volumes (generally < 1 mL/kg body weight).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)

Conclusions:

Based on a di-isoproply ether density of 723 g/L:
LD50 (male/female 14-day old) = 4600 mg/kg bw
LD50 (male young adult) = 12000 mg/kg bw
LD50 (male older adult) = 11900 mg/kg bw