tert-butyl methyl ether

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant, OECD Guideline 402 study, adequate for assessment. However, no data on analytical purity was reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl methyl ether

EC Number:

216-653-1

EC Name:

tert-butyl methyl ether

Cas Number:

1634-04-4

Molecular formula:

C5H12O

IUPAC Name:

2-methoxy-2-methylpropane

Details on test material:

- Name of test material (as cited in study report): MTBE
- Physical state: colourless liquid
- Analytical purity: not reported

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Housing: 5 animals/sex/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

- fur was clipped from the skin (not abraded)
- exposure area: 6x5 cm of the body dorsal surface
- the test article was applied uniformely by gentle inunction onto the cleared area
- the treated area was covered with a non-porous gauze patch fixed to the skin with impermeable, hypoallergic non-irritating tape (occlusive patch)
- the test side was covered in a suitable manner in order to ensure that the animals cannot ingest the test substance
- the test article was used undiluted as supplied by the sponsor at the volume of administration of 2.70 ml/kg, in order to obtain the dose of 2000 mg/kg being the density 0.740 g/ml.
- at the end of the exposure period the residual test substance was wiped off

Duration of exposure:

24 hours with 14 days observation period

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

Observation of clinical signs and mortality:
at 30 minutes, 2, 4 and 6 hours on the first day after the administration (day 1) and then twice a day up to the termination of the observation period (14 days).

Body weight:
twice pre-trail and on days 8 and 15

Gross pathology:
performed on all animals

Statistics:

No statistical analysis was performed (not needed due to the obtained results).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: No general clinical signs nor behavioural alterations were observed in any treated rat during the observation period. At the treatment site slight erythema was noted in 4 animals during the first 8 hours after the 24 hours exposure period.

Gross pathology:

At autopsy at the end of the observation period no appreciable macroscopic findings were evident in any treated rats.