Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comprehension of case reports.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
The value of corneal peeling or corneal resection in ophthalmology.
Author:
Kilgore, G. L.
Year:
1946
Bibliographic source:
Trans Am Ophthalmol Soc. 44:100-112

Materials and methods

Type of study / information:
Case report
Endpoint addressed:
eye irritation
Principles of method if other than guideline:
The use of quinine bisulphate ointment, 2 %, for several years as a clarifier of corneal opacities is described in two case reports.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): quinine bisulphate

Method

Ethical approval:
not applicable
Details on study design:
Case 1- Sex: male- Age: 33- History: Quicklime was splashed in both eyes when he was seven years of age.- Symptoms, onset and progress of the disease: Vision of right eye is 20/200, left eye 5/200- Other: A corneal resection was performed on the right eye, with removal of a horizontal band of scar tissue four mm wide and one-half mm thick from in front of the pupil. A similar horizontal band of scar tissue four mm wide and one-half mm thick was removed from the corneal surface of the left eye. Quinine bisulphate ointment (2 %) was used in each eye for a short timeCase 2- Sex: male - Age: 40- History: Patient had a gonococcal infection of each eye with ulceration of the cornea of each eye and loss of left globe from panophthalmitis. - Other: A corneal peeling operation was done under cocaine anaesthesia. A cross incision was made in the cornea to a depth of three-quarters mm followed by dissecting the four quadrants free and off. There was a small break in the epithelial covering near the centre of the cornea. Quinine bisulphate ointment (2%) were prescribed for use twice a day.
Exposure assessment:
measured

Results and discussion

Results:
Quinine bisulphate ointment has been used for a number of years as a clarifier of corneal opacities through its destruction of lymphocytes and leukocytes. Therefore, a 2 % quinine bisulphate ointment was used post-operative to improve the regeneration. Thus, we conclude that quinine is not irritating to eyes.

Applicant's summary and conclusion

Conclusions:
Quinine bisulphate ointment has been used for a number of years as a clarifier of corneal opacities. Therefore, in the two case reports a 2 % quinine bisulphate ointment was used post-operative to improve the regeneration. Thus, we conclude that quinine is not irritating to eyes.
Executive summary:

Quinine bisulphate ointment has been used for a number of years as a clarifier of corneal opacities through its destruction of lymphocytes and leukocytes. Therefore, in the two case reports a 2 % quinine bisulphate ointment was used post-operative to improve the regeneration. Thus, we conclude that quinine is not irritating to eyes.