Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been conducted in compliance with GLP and according to the OECD guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
trans-1,4-bis(iodomethyl)cyclohexane
Cas Number:
83447-96-5
Molecular formula:
C8H14I2
IUPAC Name:
trans-1,4-bis(iodomethyl)cyclohexane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3053 - 3498 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21.5°C
- Humidity (%): 30-45%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
100 mg of the test item were instilled into the conjunctival sac of one eye of each animal. The treated eyes were rinsed out with deionised water to remove the solid test item particles from the eyes of all animals one hour after instillation, carefully.
Observation period (in vivo):
60 minutes, 24, 48 and 72 hours after installation of the test item
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
The test was carried out with three male rabbits. Both eyes of each animal were examined approximately 24 hours before testing. Two to three
drops of a fluorescein sodium solution (0.5 % in deionised water) were instilled into the conjunctival sac and rinsed out again after 30 sec with
deionised water. No ocular defects were observed in any of the animals.
100 mg of the test item were instilled into the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball.
The lids were then held together gentIy for approximately 1 second in order to prevent loss of the material. The other eye of the same animal, which
remained untreated, served as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks on result:
other: 1 day (redness)
Irritation parameter:
chemosis score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks on result:
other: 1 day (only 1 animal affected)
Irritant / corrosive response data:
One day after instillation signs of irritations were not more observed.
Other effects:
The instillation of the test item caused only a slight redness of the conjunctivae in all animals and a slight swelling of the conjunctivae in one animal
one hour after instillation. The cornea and the iris were not affected.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with the results of this study and in compliance with the criteria of Appendix 6 to Directive 2001/59/EU of August 06, 2001 P2 may
be classified as a substance that is non-irritant to the eye.
Executive summary:

Only conjunctivae redness grade 1 was observed in all 3 animals at 1 hour after administration. Approx. 24 hours after administration this alteration was no longer observed and therefore fully reversible. In 1/3 animals additionally conjunctivae chemosis grade 1 was noted at 1 hours after administration and was also no longer noted 24 hours later. Based on the results of this study it can be concluded the the test substance has not irritating potential for the eyes and hence does not have to be classified.