Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-04-20 to 2010-04-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study on a structural analogous read-across substance (Please refer to the Read-Across Justification in Section 13)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, adopted 24 April 2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Tin sulphide
EC Number:
215-248-7
EC Name:
Tin sulphide
Cas Number:
1314-95-0
Molecular formula:
SSn
IUPAC Name:
Tin(II) sulfide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand White rabbits were received from Covance Research Products, Inc., Denver, PA on 03/31/10 and acclimated for at least five days. Only animals in apparent good health were made available for study assignment. Prior to being selected for this study, both eyes of each animal were examined according to the Draize technique for any evidence of irritation or abnormalities of the cornea, iris and/or conjunctiva. A Mini-Maglite® flashlight equipped with a high intensity bulb was used to aid in the examination. Three rabbits (2 males- 1 female), free from evidence of ocular irritation or abnormalities, were assigned to this study without conscious bias. The animals were born on 12/12/09. The pretest body weight range was 2.6- 3.0 kg. The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed 1/cage in suspended cages. Paper bedding was placed beneath the cages and changed at least three times/week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12-hour light/dark cycle and was kept clean and vermin free.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The test article (0.1 ml equivalent (87.6 mg)) was used for the study, in a single dose.
Duration of treatment / exposure:
The eyes of the test animals were not washed out after the application of test item.
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
Three healthy New Zealand White rabbits (2 males- 1 female), free from evidence of ocular irritation and corneal abnormalities, were dosed with tin sulfide. The test article (0.1 ml equivalent (87.6 mg)) was placed into the conjunctival sac of one eye of each rabbit. The contralateral eye served as a control. The eyes were examined pretest and scored by the Draize technique at 1, 24, 48 and 72 hours postdose. The control eyes were observed at the same time periods. Sodium fluorescein dye procedures were used at the 24-hour observation interval. Observations for toxicity and pharmacological effects were recorded at each ocular observation period. Body weights were recorded pretest and at termination. The mean total scores for 24, 48 and 72 hours were calculated by adding the total score for each time period and dividing by the number of animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0.67
Max. score:
110
Reversibility:
fully reversible within: 48 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 48 h
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
110
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
80
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
80
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.333
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes after 1 hour, cleared in two animals by 24 hours and in all animals by 48 hours. The control eyes were normal at all observation periods. There were no abnormal physical signs noted during the observation period. Body weights increased in 2/3 animals and stayed the same in one animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Tin sulfide had no eye irritating/corrosive effect in an in vivo study according to OECD guideline 405.
Executive summary:

The eye irritating/corrosive properties of tin sulfide were determined in a study with rabbits according to OECD guideline 405. There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes after 1 hour, cleared in two animals by 24 hours and in all animals by 48 hours. There were no abnormal physical signs noted during the observation period. In summary, the mean total score at 24 hours was 0.67, at 48 and 72 hours it was 0.