Ethers, C5-6-branched alkyl Me

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxy-2-methylbutane

EC Number:

213-611-4

EC Name:

2-methoxy-2-methylbutane

Cas Number:

994-05-8

Molecular formula:

C6H14O

IUPAC Name:

1,1-dimethylpropyl methyl ether

Details on test material:

- Name of test material (as cited in study report): TAME.
- Physical state: clear colorless liquid
- Analytical purity: 98.4 %
- Lot/batch No.: 25-30.11.89
- Storage condition of test material: room temperature, in darkness

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK
- Age at study initiation: not indicated
- Weight at study initiation: 3.8 kg
- Housing: individually
- Diet: appr. 100-120 gram per animla/day
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / artificial illumination from 6 to 18 hours

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the unexposed eye of each rabbit was the control

Amount / concentration applied:

100 µl TAME

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Eye irritation was recorded 1, 24, 48, 72 hours, 7, 14 and 21 days after administration.

Number of animals or in vitro replicates:

3

Details on study design:

Three albino rabbits were administered 100 μl TAME to the conjunctival sac of one eye while the other remained as an untreated control. 24 hours after instillation, the test substance of the treated eye was rinsed with saline. Eye irritation was scored according to Draize and recorded 1, 24, 48, 72 hours, 7, 14 and 21 days after administration.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: maximal score (2) at 24 and 48 hours

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effects were seen at all

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects were seen at all

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1, 24 hours

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: maximal score (4) at 1 hour. The effects were observed in only one of the animals.

Irritant / corrosive response data:

The data do not imply classifying TAME as an eye irritating substance.

Other effects:

Discharge (grade 2-3) was observed after 1 hour in all three animals.