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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to standard methods under GLP as a final step of skin irritation testing. The study is reliable, relevant, and adequate for classifcation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
TEST ANIMALS
- Source: Covance Research products, Inc., Denver, PA
- Age at study initiation: ± 5 months
- Weight at study initiation: 3.0-3.1 kg
- Fasting period before study: Not provided
- Housing: Individually in suspended cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (#5321) was provided daily.
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature controlled
- Humidity (%): Not provided
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 2012-01-31 To 2012 02 02

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: non treated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL equivalent 94.4 mg
- Concentration (if solution):
Duration of treatment / exposure:
single application, the lids were held close for approximately 1 second after instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (males)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize technique

TOOL USED TO ASSESS SCORE: Mini-Maglite® flashlight

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 2 animals with eye redness

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Tin disulfide is not an ocular irritant according to CLP & GHS Guidelines.
Executive summary:

Three healthy New Zealand White rabbits (male), free from evidence of ocular irritation and corneal abnormalities were dosed with tin disulfide. The test article (0.1 mL equivalent (94.4 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.

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation of redness and or discharge, was noted in two out of three eyes, one eye cleared by 24 hours and the other eye by 48 hours. The control eyes appeared normal at all observation periods. There were no abnormal physical signs noted during the observation period. One animal gained body weight and the other two animals remained the same.