Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
according to guideline
Guideline:
other: Federal Register 38, No 187, § 1500.41, S. 27019 (27/09/1973)
Principles of method if other than guideline:
Draize test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-1-ol
EC Number:
205-289-9
EC Name:
2-methylbutan-1-ol
Cas Number:
137-32-6
Molecular formula:
C5H12O
IUPAC Name:
2-methylbutan-1-ol
Details on test material:
- Name of test material (as cited in study report): 2-methylbutanol-1
- Physical state: liquid
- Analytical purity: ca. 99%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: young adult animals
- Weight at study initiation: 2.71±0.17 kg (2.8±0.17 kg at the end of the study)
- Diet (e.g. ad libitum): Ssniff; ad libitum
- Water: ad libitum

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): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
one application, not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM:
acc. to Federal Register, No. 187, § 1500.41, p. 27029, 1973:

Cornea
(A) Opacity-degree of density (area most dense taken for reading)
0 = No opacity
1 = Scattered or diffuse area, details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Opalescent areas, no details of iris visible, size of pupil barely discernible
4 = Opaque, iris invisible

(B) Area of cornea involved
1 = One quarter (or less) but not zero
2 = Greater than one quarter, but less than half
3 = Greater than half, but less than three quarters
4 = Greater than three quarters, up to whole area

Iris
(A) Values
0 = Normal
1 = Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination af any thereof) iris still reacting to light (sluggish reactions is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)

(3) Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0 = Vessels normal
1 = Vessels definitely injected above normal
2 = More diffuse, deeper crimson red, individual vessels not easily discernible
3 = Diffuse beefy red

(B) Chemesis
0 = No swelling
1 = Any swelling above normal (includes nictitatinq membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids about half closed to completely closed

(C) Discharge
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8d (in 1/6 animals)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritant / corrosive response data:
24-72 h: Slight opacity of the cornea, ciliary injections in the iris, conjunctivae: obvious redness, obvious to slight swelling, secretion.
8 days: slight corneal opacity in 5/6 animals, slight redness of conjunctivae in 5/6, obvious redness in 1/6 animals, slight secretion in 2/6 animals.
Overall irritation score: 34 of maximally 110 (not reversible within 8 d).
Other effects:
Scar formation of eyelids was observed in 2 animals 24 hours after treatment and in a total of 3 animals from day 2 up to the end of the observation period.

Any other information on results incl. tables

Results:

Readings Animal cornea Iris conjunctiva Symptons
opacity area redness swelling discharge
24 h 1 1 4 1 2 2 1 m,sc
2 1 4 1 2 2 1 m
3 1 4 1 2 2 2 m, sc
4 1 4 1 2 2 2  
5 1 4 1 2 2 2 m
6 1 4 1 2 2 2 m
48 h 1 1 4 1 2 1 1 m, sc
2 1 4 1 2 1 1 m
3 1 4 1 2 2 1 m, sc
4 1 4 1 2 1 1 sc
5 1 4 1 2 1 1 m
6 1 4 1 2 1 1 m
72 h 1 1 4 1 2 1 1 m, sc
2 1 4 1 2 1 1 m
3 1 4 1 2 1 1 m, sc
4 1 4 1 2 1 1 m, sc
5 1 4 1 2 1 1 m
6 1 4 1 1 0 1 m
8 d 1 1 1 0 1 0 0 sc
2 0 0 0 1 0 0  
3 1 4 1 2 0 1 sc
4 1 3 0 1 0 1 sc
5 1 1 0 1 0 0  
6 1 1 0 1 0 0  
mean 24 - 72 h 1 1.0 4.0 1.0 2.0 1.3 1.0  
2 1.0 4.0 1.0 2.0 1.3 1.0
3 1.0 4.0 1.0 2.0 1.7 1.3
4 1.0 4.0 1.0 2.0 1.3 1.3
5 1.0 4.0 1.0 2.0 1.3 1.3
6 1.0 4.0 1.0 1.7 1.0 1.3
mean   1.0 4.0 1.0 1.9 1.2 1.3

m: myosis

sc: scar

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU