Butane, 2-ethoxy-2-methyl-

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:

other: Modern GLP compliant guideline study, no restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (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:

2-ethoxy-2-methylbutane

EC Number:

618-804-0

Cas Number:

919-94-8

Molecular formula:

C7H16O

IUPAC Name:

2-ethoxy-2-methylbutane

Details on test material:

- Name of test material (as cited in study report): TAEE, tert-amyl ethyl ether, CAS No. 919-94-8
- Lot/batch No.: 00931302
- Description: colourless liquid
- Purity: 99.4%
- Date received: 22 October 2008

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: 8-9 wk
- Weight at study initiation: 160-178 g
- Fasting period before study: yes, overnight
- Housing: group, 5/cage
- Diet (e.g. ad libitum): yes; feed returned approx. 3 hr post-treatment
- Water (e.g. ad libitum): yes
- Acclimation period: 7-9 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 4 November 2008 To: 20 November 2008

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- None used

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 groups of 3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days -1, 1, 4, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight:

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortality or adverse effects

Mortality:

None

Clinical signs:

other: Piloerection was noted in the first group of animals, 3 hr after dosing. Piloerection and hunched posture were noted in the second group of animals 3 hr after dosing, with piloerection and ataxia noted 4 hr after dosing.

Gross pathology:

None present except for slight distension of the uterus in 1 animal.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral LD50 >2000 mg/kg bw

Executive summary:

Acute oral toxicity was determined in GLP compliant guideline study (acute toxic class method, method B1 of directive 2004/73/EC) using 6 young adult female Sprague Dawley rats (age 8 -9 wk, bwt 160 -178 g). The test substance was administered neat as a single dose by gavage (2000 mg/kg bwt) following an overnight fast, and the animals observed for 14 days post-treatment. Access to food recommenced approx. 3 hr post-treatment. There were no deaths or any clinical signs noted following treatment and the animals gained weight normally. No gross abnormalities detected at on study day 14. The results demonstrate that the acute oral LD50 of tert-amyl ethyl ether is greater than 2000 mg/kg bwt.