Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 15, 2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD GUIDELINES FOR TESTING OF CHEMICALS 438
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99.59%
Description: clear liquid
Storage: room temperature

Test animals / tissue source

Species:
other: Isolated Chicken Eyes
Details on test animals or tissues and environmental conditions:
CHICKEN HEADS COLLECTION AND TRANSPORT
Species of chicken: ROSS 308

Test system

Vehicle:
physiological saline
Amount / concentration applied:
The Trichloroacetic acid was mixed with saline solution at a concentration of 30 (w/v) %.
Observation period (in vivo):
The control eye and test eyes were evaluated pre-treatment and at approximately 30, 60, 75, 120, 180 and 240 minutes after the post-treatment rinse. Minor variations within ±5 minutes were considered acceptable.
The cornea thickness and cornea opacity were measured at all time points. Fluorescein retention was measured on two occasions, at base line (t=0) and 30 minutes after the post-treatment rinse.

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Value:
>= 0 - <= 0.5
Remarks on result:
other: moderately irritanting

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 75 min
Score:
0
Max. score:
0.5
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 120 min
Score:
0.5
Max. score:
0.5
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 240 min
Score:
0.5
Max. score:
0.5
Reversibility:
not reversible

Any other information on results incl. tables

After the zero reference measurements, the eye was held in horizontal position and 30 μl of 1,2-Dichloropropane was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated in a similar way with 30 μl Trichloroacetic acid 30 (w/v) %. The negative control eye was treated with 30 μL of isotonic saline.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
In this in vitro eye irritation study in the Isolated Chicken Eyes model with 1,2-Dichloropropane, the results suggests that the test item was moderately irritating, but according to the guideline OECD 438, 1,2-Dichloropropane does not require a classification as a severe eye irritant; an in vivo rabbit study is required for classification.