3-methylbut-2-en-1-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Method: Federal Register 38, No. 187, § 1500.42

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted.

Test material

Test material information

Constituent 1

Reference substance name:

3-methylbut-2-en-1-ol

EC Number:

209-141-4

EC Name:

3-methylbut-2-en-1-ol

Cas Number:

556-82-1

Molecular formula:

C5H10O

IUPAC Name:

3-methylbut-2-en-1-ol

Details on test material:

- Name of test substance: 3-Methylbut-2-en-1-ol (Prenol)
- Analytical purity: 99 %

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: M. Gaukler, Offenbach, Germany
- Weight at study initiation: ca. 3.4 kg
- Diet: Ssniff K, standard diet for rabbits and guinea pigs (Intermast GmbH, Soest, Germany), ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of the same animal served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration: undiluted

Duration of treatment / exposure:

the substance was not washed out

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3 (2 males and 1 female)

Details on study design:

APPLICATION
Single application to the conjunctival sac of the right eyelid and compression of the eye lid.

REMOVAL OF TEST SUBSTANCE
- The test substance was not washed out.

READINGS:
- 24, 48, 72 hours and 8 days after instillation.

SCORING SYSTEM:
- Draize scores
- Irritation score: Cornea: 0-4 (opacity and area affected); Iris: 0-2; Conjunctiva: 0-3  (redness), 0-4 (chemosis)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 8 days

Other effects:

No other effects observed.

Any other information on results incl. tables

Exposition: Single application to the conjunctival sac of the eyelid; the substance is not washed out
Animal	Reading	Cornea Opacity	Iris	Conjunctiva		Additional findings
				Redness	Chemosis
1	24 h	1	0	2	2
2	24 h	1	0	2	2	scar
3	24 h	1	0	2	2	scar
1	48 h	1	0	2	1
2	48 h	1	0	2	1	scar
3	48 h	1	0	2	1	scar
1	72 h	1	0	2	1
2	72 h	1	0	1	1	scar
3	72 h	1	0	2	1	scar
1	8 d	2	0	1	1
2	8 d	0	0	0	0	scar
3	8 d	0	0	1	0	scar
mean animal 1	24 - 72 h	1.00	0.00	2.00	1.33
mean animal 2	24 - 72 h	1.00	0.00	1.67	1.33
mean animal 3	25 - 72 h	1.00	0.00	2.00	1.33
mean	24 - 72 h	1.00	0.00	1.89	1.33