Registration Dossier

Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: 2 animals
Time point:
other: 1 h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
other: 2 animals
Time point:
24 h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
other: 2 animals
Time point:
other: 8 days
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
other: 2 animals
Time point:
other: 1h - 8 days
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
other: 2 animals
Time point:
other: 1h
Score:
ca. 2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
other: 2 animals
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
other: 2 animals
Time point:
other: 8 days
Score:
ca. 2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
other: 2 animals
Time point:
other: 1 h
Score:
ca. 3 - ca. 4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
other: 2 animals
Time point:
24 h
Score:
ca. 1 - 2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
other: 2 animals
Time point:
other: 8 days
Score:
ca. 1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
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.