Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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: Chracterization of the material not provided

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Stannous octoate
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: sanitized
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in cages with a grid floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 deg C
- Humidity (%): 52%

IN-LIFE DATES: From: 1980-04-02 To: 1980-04-09

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: FDA

TOOL USED TO ASSESS SCORE: standard illumination

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
12
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
13
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
13
Reversibility:
not fully reversible within: 7 days

Any other information on results incl. tables

No corneal responses were observed at 1 h, but scattered or diffuse areas of opacity (score 1) were noted in all treated eyes a t 24 h, 48 h and 72 h. At 7 days, the response was more severe in all but one of the treated eyes, and in one eye complete corneal opacity (score 4) prevented observation of the iris. Very slight iridial responses were noted in 5/6 eyes treated with stannous octoate at 1 h. The maximum score for iridial damage (2) was recorded for 5/6 treated eyes at 24 h and all observable irises a t 48 h, 72 h and 7 days. Positive responses for conjunctival redness and chemosis (2 or above) and moderate or severe discharge (score 2 or 3) were recorded in all eyes treated with stannous octoate at all readings.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tin bis(2 -ethylhexanoate) elicited severe ocular responses involving the cornea and iris, as well as marked conjunctival responses.
Executive summary:

Six New Zealand White rabbits (3 male,3 female) were used in the study. Test material, at 0.1 mL, placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1 or 2 sec. The other eye remained untreated to serve as a control. Instillation of 0.1 ml of the test material into the eyes of rabbits resulted incorneal and iridial responses to treatmentand severe conjunctival reactions which persisted throughoutthe test. The study was assigned a K-2 rating. Tin bis(2 -ethylhexanaote) may be classified as a severe eye irritant in view of the corneal and iridial responses to treatment and severe conjunctival reactions which persisted throughout the test.