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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tin(II) oxalate
EC Number:
212-414-0
EC Name:
Tin(II) oxalate
Cas Number:
814-94-8
Molecular formula:
C2H2O4.Sn
IUPAC Name:
tin(II) oxalate
Details on test material:
- Name of test material (as cited in study report):Tin (II) Oxalate - Molecular formula (if other than submission substance):C2H2O4.Sn- Molecular weight (if other than submission substance):206.7096- Substance type: Organometallic- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Age at study initiation:10 to 12 weeks- Weight at study initiation:2.0kg ±200g- Housing:Rabbit was housed in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.- Diet (e.g. ad libitum):Pelleted feed supplied ad libitum- Water (e.g. ad libitum):Community tap water passed through ‘Aqua Guard on line water filter’ was kept in bottles, ad libitum.- Acclimation period:The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.ENVIRONMENTAL CONDITIONS- Temperature (°C):22-25 deg.C- Humidity (%):40-60% - Air changes (per hr):10-15 air changes per hour- Photoperiod (hrs dark / hrs light):illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark..

Test system

Vehicle:
other: distilled water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit):0.1 gm
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
21 days.
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done):after 24 hrs.- Time after start of exposure:1, 24, 48 and 72 hours SCORING SYSTEM:Draize et al.TOOL USED TO ASSESS SCORE: biomicroscope and hand slit lamp further examined with the aid of fluorescein.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hrs.
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: Tin (II) Oxalate is practically non-irritant to the eyes of New Zealand white rabbit at the dose level of 0.1g under test condition.
Irritant / corrosive response data:
The test compound Tin (II) Oxalate (CAS No.-814-94-8) when applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produce any eye irritation throughout the observation period of 72 hours. After that the animals were observed for 21 days for any eye irritation and eye discharge.
Other effects:
Clinical Signs:The test compound Tin (II) Oxalate (CAS No.-814-94-8) applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Based on the result obtained from present study, it can be concluded that the test compound Tin (II) Oxalate (CAS No.-814-94-8) is practically non-irritant to the eyes of New Zealand white rabbit at the dose level of 0.1g under test condition.
Executive summary:

Theacute eye irritation study ofTin (II) Oxalate (CAS No.-814-94-8) was conducted in New Zealand White Rabbits as per the OECD- 405 Guideline for testing of chemicals. The study was conducted stepwise as follows-

Initial test (using one animal):

One healthy rabbits of body weight 2.13Kg was selected for study after acclimatization. Rabbit was examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound.

The test compound was applied in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball at the dose rate of0.1gm.The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hoursafter the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.

The test compound Tin (II) Oxalate (CAS No.-814-94-8) when applied to conjunctival sac of rabbit in the amount of0.1gmdid not produce any eye irritation or inflammation. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc.

Confirmatory test (using two additional animals):

The result obtained from the initial test was confirmed in additional two animal of same sex and same dose level (OECD-405, paragraph-21).

In the confirmatory test the test compound was applied in the amount of 0.1 gm in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hoursafter the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.

In the confirmatory test, the test compound Tin (II) Oxalate (CAS No.-814-94-8) when applied to the conjunctival sac of the rabbits did not produce eye irritation during the entire observation period. However, some blood vessels observed hyperemic upto 24 hours after the application of test compound. There were no other signs observed throughout the observation period of 21 days.

Based on above findings, it can be concluded that the test compound Tin (II) Oxalate (CAS No.-814-94-8) is practically non-irritant at the tested dose level 0.1 mg under test condition.