Registration Dossier

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1958
Report date:
1958

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance in the amount indicated was applied to the conjunctival sac of rabbits. The non-treated adjacent eye served as control. The animals were observed several times on the treatment day and 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 hours after substance application. Findings were graded as described in OECD test guideline 405.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropan-1-ol
EC Number:
205-864-4
EC Name:
3-aminopropan-1-ol
Cas Number:
156-87-6
Molecular formula:
C3H9NO
IUPAC Name:
3-aminopropan-1-ol
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: concurrent NaCl
Amount / concentration applied:
one drop (ca. 0.05 mL)
Duration of treatment / exposure:
single application
Observation period (in vivo):
24 days
Number of animals or in vitro replicates:
4
Details on study design:
SCORING SYSTEM: no scores used in the raw data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
other: no scores used in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
other: no scores used in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
other: no scores used in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
other: no scores used in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
One drop of the undiluted test substance applied to the conjunctival sac of the eye produced very strong reddening within 10 min combined with enhanced secretion, corneal opacity, and slight chemical burning of the mucosa. The signs of mucosal irritation/corrosion were visible for at least 3 days. On day 3 ciliar injections and mucosal bleedings were observed combined with smeary secretion, slight chemosis and diffuse corneal opacity. After 6 days clear signs of irreversible corneal damage and iritis were observable including scar formation and cloudy corneal opacity. At day 8 slight reddening, slight mucosal bleedings, smeary secretion and cloudy corneal opacity were still visible.
At the end of the study period (day 24) irreversible signs of corneal damage were observed as well as ciliar injections in the lower half of the eyeball in two animals. Two animals were euthanized on day 6 of the study due to massive chemical burnings of the eye including black-brown necroses, strong bleedings/bloody secretions and foggy corneal opacity.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
3-Aminopropan-1-ol causes severe eye damage.
At the end of the study period (day 24) irreversible signs of corneal damage were observed as well as ciliar injections in the lower half of the eyeball in two animals. Two animals were euthanized on day 6 of the study due to massive chemical burnings of the eye including black-brown necroses, strong bleedings/bloody secretions and foggy corneal opacity.