Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
October 28, 1988 - November 2, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Principles of method if other than guideline:
The purpose of the study was to estimate the eye irritancy potential of the test substance. Isolated bovine eyes (BE) were used to predict corneal damage whereas the chorioallantoic membrane (CAM) of chicken eggs indicated conjunctival irritancy.
The study was carried out as described in the following paper:
Waterings, P.J.J.M. and van Erp, Y.H.M. (1987). Alternative methods in Toxicology Vol. V: In Vitro Toxicology - Approaches to Validation. Ed. A.M. Goldberg, M.A. Liebert Inc. NY, USA.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
The following test substance data have been submitted by the sponsor, who accepts full responsibility for the validity thereof.
- Identity: FAT 92'185/A
- Batch No: EN 27.86
- Physical Appearance: solid
- Purity: AS: 55% humid/water
- Stability: unknown
- Storage: in the original container at room temperature in the dark
- Safety Precautions: lab coat and gloves will be sufficient to ensure personal health and safety

Test and reference substances
The investigated chemical substance was tested in the form it was provided by the sponsor. The reference substances toluene and acetone (p.a.) were purchased from Merck (Darmstadt, FRG). Purity and stability of the compounds were not confirmed.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: mean interpretation score
Run / experiment:
BE assay
Value:
1.5
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: slight irritating
Irritation parameter:
other: mean interpretation score
Run / experiment:
CAM assay
Value:
0.38
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Mean Cumulative Scores and Interpretation for FAT 92'185/A in the BECAM Assay

 

BE assay mean score interpretation

CAM assay mean score interpretation

final interpretation

 

 

1.5 slight

0.38 non irritating

slightly irritating

For toluene, a score of 1.5 was obtained in the BE assay whereas the average score in the CAM assay was 1.0. Acetone treatment resulted in a score of 3.5 in the BE assay and an average score of 2.0 in the CAM assay. As the effects, produced by acetone and toluene, fell within the historical range and the untreated eyes and eggs showed no signs of irritation, the results were considered to be valid.

To evaluate the effects observed in both assays the documented in vivo effects of the two reference substances toluene and acetone were taken into consideration (3). Toluene produces slight transient conjunctival irritation with negligible to slight corneal epithelial damage without opacity in the rabbit eye, while no serious effects have been reported in case of accidental exposure of human eyes. Acetone causes temporary edema and moderate corneal opacity with epithelial damage to exposed rabbit eyes while in man reversible corneal opacity has been observed. The test substance revealed slight corneal damage consisting of slight opacification and affection of the epithelial integrity in all eyes. After extra rinsing the effects on the CAM were classified as negligible and consisted of vascular injection five minutes after application in egg no. 3 and minute bleedings after two minutes in egg no. 1,

Applicant's summary and conclusion

Interpretation of results:
other: slight irritation may be expected after acute eye exposure to FAT 92'185/A.
Conclusions:
It is concluded that slight irritation may be expected after acute eye exposure to FAT 92'185/A.
Executive summary:

The substance revealed slight corneal damage and the effects on the CAM were classified as negligible. It is concluded that slight irritation may be expected after acute eye exposure to FAT 92185/A.