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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:
Jan 5 1995 - Jan 26 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to GLP and guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Troclosene sodium
EC Number:
220-767-7
EC Name:
Troclosene sodium
Cas Number:
2893-78-9
Molecular formula:
C3HCl2N3O3.Na
IUPAC Name:
sodium 3,5-dichloro-2,4,6-trioxo-1,3,5-triazinan-1-ide
Details on test material:
- Name of test material (as cited in study report): ACL 60
- Physical state: White granular powder
- Analytical purity: Sodium dichloroisocyanurate - 96.0-98.0%, sodium chloride -0.1%, water 0.5%
- Lot/batch No.: #LBO4-2118
- Stability under test conditions: Stable provided material is kept dry
- Storage condition of test material: Stored at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidsons Mill Farm, South Brunswick, NJ
- Age at study initiation: Adult
- Housing: Suspended stainless steel caging with mesh floors
- Diet: Pelleted Purina Rabbit Chow #5326
- Water: ad libitum
- Acclimation period: 22 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 69-76
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark


Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Observation period (in vivo):
Irritation was observed at 1, 24, 48 and 72 hours and 4, 7, 10, 14, 17 and 21 days post-instillation
Number of animals or in vitro replicates:
6 (3/sex)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of all animals were washed with 30ml of physiological saline 20-30 seconds after instillation.


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: Occular irritation was evaluated using a high-intensity white light (Mag Lite). The fluorescein dye procedure was used at 24 hours and at all subsequent scoring intervals to evaluate the extent of corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
animal 1 and 2
Time point:
other: 24, 48, 72 h
Score:
1
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
1.33
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1, 2 and 3
Time point:
other: 24, 48, 72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal 1,2 and 3
Time point:
other: 24, 48, 72 h
Score:
2.67
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1 and 3
Time point:
other: 24, 48, 72 h
Score:
2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
3
Irritant / corrosive response data:
Severe irritation including corneal opacity, iritis and conjunctivitis was noted in all treated eyes throughout the study. Pannus was also noted in five of six animals between days 7 and 21. A hematoma was evident on the cornea of two animals on day 10 of the study and two rabbits exhibited a slight green dicolouration of the conjunctival tissue. Although by day 21, conjunctivitis and iritis cleared from one and two eyes respectively, ocular irritation persisted in all animals through study termination.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sodium dichloroisocyanurate is corrosive to eyes due to the persistance of irritation which was not fully reversible within the observation period of 21 days