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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:
18 Sept 1989 - 26 Dec 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2,2-2,3 kg
- Diet (e.g. ad libitum): ad libitum, regular rabbit diet
- Water (e.g. ad libitum): tsp water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 deg C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
Test substance was placed into the right conjunctival sac. Left eye was the control eye. At 72h the eye was treated with Na-fluorescein solution to explore corneal damage. Observations were made at 1, 24, 48, 72 hours, and at days 6, 8, 10, 13, 16 and 21.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
22
Max. score:
110
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.56
Reversibility:
fully reversible within: 6 days
Remarks on result:
probability of mild irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.11
Reversibility:
fully reversible within: 16 days
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.78

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The eye irritation potential of tetrakis(2-ethylhexane-1,3-diolato)titanium was evaluated when introduced to the eyes of male rabbits. The test material demonstrated a slight irritant effect on the eye and mucosa of rabbit with irritation index of 22/110 according to the Draize.
Executive summary:

Tetrakis(2 -ethylhexane-1,3 -diolato)titanium was applied undiluted into the eyes of three rabbits. After 72 hours, treated eye of rabbit was washed with physiological NaCl-solution. The observations were made at 1, 24, 48 and 72 hours and at 6, 8, 10, 13, 16 and 21 days. Tetrakis(2 -ethylhexane-1,3 -diolato)titanium irritated mildly the cornea and conjunctiva of rabbit eyes. All treatment related effects were fully reversible within 16 days.