1,3,5-trioxane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Remarks:

(Hoechst AG, Toxicology and Pathology)

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-trioxane

EC Number:

203-812-5

EC Name:

1,3,5-trioxane

Cas Number:

110-88-3

Molecular formula:

C3H6O3

IUPAC Name:

1,3,5-trioxane

Details on test material:

- Name of test material (as cited in study report): Trioxane
- Physical state: crytals
- Analytical purity: 99.1 %
- Impurities (identity and concentrations): ca. 0.1 % Triethanolamine, ca. 0.8 % water
- Storage condition of test material: 4 °C in dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.3-2.7 kg
- Diet (e.g. ad libitum): Altromin 2123 diet
- Water (e.g. ad libitum): deionized water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

1 week

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline (37 °C)
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 rabbits

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 4

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h