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: The study was conducted according to state of the art methodology at that time; methods are well described and results are presented reasonable in the text and in tabular format.

Data source

Reference
Reference Type:
publication
Title:
Effects of some silver salts on the eye
Author:
Calvery, H.O.; et al.
Year:
1941
Bibliographic source:
Arch. Ophthalmol. 25, 839-847

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study on effects of some silver salts on the eye. The following irritation parameters were scored in this old study (1941): hyperemia, swelling, scar tissue formation, mucopurulent exudation, coagulation and corneal injury. These parameters are different from current standardised test protocols. Unfortunately, they cannot be entered in the technical dossier in a way that the CSR plugin provides a meaningful output in the CSR. Thus we merely state that based on this study silver nitrate can classified as highly irritating to eyes. The full study report is attached to the corresponding endpoint record in the technical dossier.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): silver nitrate
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
other: pure albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: several different sources
- Age at study initiation: young adults (exact ages were not known)
- Weight at study initiation: 1.5 - 3 kg
- Housing: in air-conditioned quarters, individually housing
- Diet: standard diet
No further details are given.

Test system

Vehicle:
not specified
Controls:
other: the right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The material was administered by instilling 0.2 - 1.0 drop of the solution into the lower cul-de-sac of the left eye.
- Concentration (if solution): The concentrations of the solutions varied in strength from 1 to 12%, calculated on the basis of silver nitrate.
- Positive controls: One group of animals received distilled water, another 3% boric acid and another an 0.85% saline solution.
Duration of treatment / exposure:
2 to 5 minutes
Observation period (in vivo):
at least once every 24 hours
Number of animals or in vitro replicates:
up to 10 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 2 to 5 minutes after application a lavage of 1% boric acid was used in the eye.

SCORING SYSTEM:
Conditions evaluated as follows
0 = no observed changes
1 = mild changes or small amount
2 = moderate changes or a moderate amount
3 = severe changes or a large amount
4 = intense changes or an enormous amount

Results and discussion

In vivo

Irritant / corrosive response data:
Study on effects of some silver salts on the eye. The following irritation parameters were scored in this old study (1941): hyperemia, swelling, scar tissue formation, mucopurulent exudation, coagulation and corneal injury. These parameters are different from current standardised test protocols. Unfortunately, they cannot be entered in the technical dossier in a way that the CSR plugin provides a meaningful output in the CSR. Thus we merely state that based on this study silver nitrate can classified as highly irritating to eyes. The full study report is attached to the corresponding endpoint record in the technical dossier.
Other effects:
Positive controls: In all of these animals the results were negative or there was mild hyperemia, the distilled water being th greatest offender, indicating that osmotic properties may play some part.

Any other information on results incl. tables

Study on effects of some silver salts on the eye. The following irritation parameters were scored in this old study (1941): hyperemia, swelling, scar tissue formation, mucopurulent exudation, coagulation and corneal injury. These parameters are different from current standardised test protocols. Unfortunately, they cannot be entered in the technical dossier in a way that the CSR plugin provides a meaningful output in the CSR. Thus we merely state that based on this study silver nitrate can classified as highly irritating to eyes. The full study report is attached to the corresponding endpoint record in the technical dossier.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU