3-methylbut-3-en-1-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1968-10-14 to 1968-10-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

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:

Before OECD Guideline 405 was established in 1984, skin irritation was tested using an internal method (BASF Test); the procedure of which is similar to OECD TG 405.

GLP compliance:

no

Remarks:

pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

3-methylbut-3-en-1-ol

EC Number:

212-110-8

EC Name:

3-methylbut-3-en-1-ol

Cas Number:

763-32-6

Molecular formula:

C5H10O

IUPAC Name:

3-methylbut-3-en-1-ol

Details on test material:

- Name of test material (as cited in study report): 3-methyl-3-buten-1-ol
- Analytical purity: 99%
No further data

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
2 male Vienna White rabbits
- Weight at study initiation: 2.65 kg (animal #1), 2.87 kg (animal #2)
- Weight at study termination: 2.74 kg (animal #1), 2.9 kg (animal #2)
No further data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: saline-treated adjacent eye of test animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.05 ml

Duration of treatment / exposure:

instillation without rinsing

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
BASF scoring system, convertible to Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: 2 animals

Time point:

other: 1 h

Score:

ca. 3

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

other: 2 animals

Time point:

24 h

Score:

ca. 3

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

other: 2 animals

Time point:

other: 8 days

Score:

ca. 3

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

iris score

Basis:

other: 2 animals

Time point:

other: 1h - 8 days

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

other: 2 animals

Time point:

other: 1h

Score:

ca. 2

Max. score:

3

Reversibility:

not reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

other: 2 animals

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

not reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

other: 2 animals

Time point:

other: 8 days

Score:

ca. 2

Max. score:

3

Reversibility:

not reversible

Results 8

Irritation parameter:

chemosis score

Basis:

other: 2 animals

Time point:

other: 1 h

Score:

ca. 3 - ca. 4

Max. score:

4

Reversibility:

not reversible

Results 9

Irritation parameter:

chemosis score

Basis:

other: 2 animals

Time point:

24 h

Score:

ca. 1 - 2

Max. score:

4

Reversibility:

not reversible

Results 10

Irritation parameter:

chemosis score

Basis:

other: 2 animals

Time point:

other: 8 days

Score:

ca. 1

Max. score:

4

Reversibility:

not reversible

Results 11

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 13

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 14

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 15

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 16

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 17

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

2

Results 18

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 19

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

1-hour reading:
strong conjunctival redness, very strong edema (chemosis), strong corneal  opacity, brown colouration of the mucosa

24-hour reading:
slight conjunctival redness, strong edema (chemosis), strong corneal  opacity, brown colouration of the mucosa

8-day reading: strong conjunctival redness, slight edema (chemosis), moderate corneal  opacity, vascularization, staphyloma

Saline control:
No signs of irritation were observed at any reading.

Other effects:

No significant change in body weight was observed for the two animals.

Any other information on results incl. tables

Table:  Findings and scores (converted to Draize system)

 

Reading	Eye	Animal No.	Corneal opacity	Iris	Conjunctival redness	Chemosis	Other findings
1 h	Treated	1 2	3 3	0 0	2 2	2 3-4	brown colouration of the mucosa brown colouration of the mucosa
	Control	1 2	No findings
24 h	Treated	1 2	3 3	0 0	1 1	1 2	bleeding and brown colouration of the mucosa bleeding and brown colouration of the mucosa
	Control	1 2	No findings
8 d	Treated	1 2	3 3	0 2	2 2	1 1	mucosal bleeding, vascularization, staphyloma mucosal bleeding, vascularization, staphyloma
	Control	1 2	No findings

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test substance implies the risk of serious damage to eyes.