1,4-dioxane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Application volume 50 µL, 2 animals, 8 days observation period

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dioxane

EC Number:

204-661-8

EC Name:

1,4-dioxane

Cas Number:

123-91-1

Molecular formula:

C4H8O2

IUPAC Name:

1,4-dioxane

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: 2.99 kg (male); 3.21 kg (male)

ENVIRONMENTAL CONDITIONS
no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 50 µL

Duration of treatment / exposure:

eye remaind unwashed after application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no washing

SCORING SYSTEM:
Discriptive scoring system comparable to draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

iris score

Basis:

animal: #1 & #2

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

Mucous deposits on the eye were observed the 1st day after application.

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

Animal 1 (male):  day 1: 2.99 kg; day 8: 3.11 kg

Animal 2 (male): day 1: 3.21 kg; day 8: 3.19 kg

Animal	Reading	Opacity	Redness	Chemosis	Comment
1	1 h	1	1	2	mucous deposits
2	1 h	1	1	1	mucous deposits
1	24 h	1	1	2	mucous deposits
2	24 h	1	1	1	mucous deposits
1	48 h	2	2	1	blood and scar (scraching)
2	48 h	1	1	0	blood (scraching)
1	72 h	1	1	1	blood and scar (scraching)
2	72 h	0	0	0
1	8 d	0	1	0
2	8 d	0	0	0
mean	24 - 72 h	1	1	0.8

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria