Diisopentyl ether

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diisopentyl ether

EC Number:

208-857-4

EC Name:

Diisopentyl ether

Cas Number:

544-01-4

Molecular formula:

C10H22O

IUPAC Name:

3-methyl-1-(3-methylbutoxy)butane

Details on test material:

- Name of test material (as cited in study report): Diisopentyl ether
- Analytical purity: 99.2%
- Lot/batch No.: TAP 625

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier (53940 Le Genest St Isle - France)
- Age at study initiation: 8 weeks old
- Weight at study initiation: 191 - 205 g
- Housing: group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid containing sawdust bedding
- Diet (e.g. ad libitum): free access to standard diet (M20, SDS).
- Water (e.g. ad libitum): free access to tap water.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h
- Air changes (per hr): approx. 15 changes per hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test item was administered as supplied by gavage under a volume of 2.57 mL/kg body weight (corresponding to 2 g/kg bw, according to the calculated density).

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

six females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for a period of 14 days to identify any behavioural or toxic effects. The rats were weighed on day 0 (just before administering the test item) and at 2, 7 and 14 days after dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related to the administration of the test item were observed.

Gross pathology:

Macroscopical examination of the animals at the end of the study did not reveal treatment related changes.

Other findings:

Not applicable.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of diisopentyl ether is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered as 5000 mg/kg body weight by oral route in the rat.

Executive summary:

In a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, the test item diisopenyl ether was administered to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight.

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normaly throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related changes.

In conclusion, the LD50 of diisopentyl ether is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered as 5000 mg/kg body weight by oral route in the rat.