Registration Dossier

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: Acceptable study which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Method equivalent to Draize test.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Clear colorless liquid
No other data

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
-
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (3: unwashed, and 3: washed)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With three of the treated animals, the treated eye was washed with flowing water initiated 20 to 30 seconds after instillation and continued for 1 minute.
- Time after start of exposure: 20 to 30 seconds

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
>= 0
Reversibility:
not reversible
Remarks on result:
other: not scorable (black necrosis)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
>= 0
Reversibility:
not reversible
Remarks on result:
other: not scorable (not visible)

Any other information on results incl. tables

Unwashed: the corneal opacified completely thus totally obscuring the iris. The conjunctivae became necrotic black with minimal chemosis. This ocular reaction occurred within seconds and showed no further change.

Scores at 1, 2 and 4 hours as well as daily for seven days remained persistently the same:

Cornea: 4

Iris: not scorable (not visible)

Conjunctival redness: not scorable (black necrosis)

Chemosis: 1

Washing did not alter the irritant reaction in any discernible manner. Scores were identical with those of unwashed eyes. Under these experimental conditions, mono-n-propylamine is considered corrosive to the eye.

Applicant's summary and conclusion