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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:
June 17, 1993 - August 27, 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study predates current guideline. However, the study is similar to a current OECD 405 guideline study and it is performed according to EPA TSCA Good Laboratory Practice Standards (40 CFR 792).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The eye of one rabbit was washed after 20 seconds and 0,01ml of the test material was introduced into the eye
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Titanium tetra(octanolate), branched and linear
EC Number:
281-199-3
EC Name:
Titanium tetra(octanolate), branched and linear
Cas Number:
83897-91-0
Molecular formula:
C32H68O4Ti, molecular weight range not applicable (UVCB substance)
IUPAC Name:
titanium tetra(octanolate), branched and linear
Details on test material:
- Name of test material (as cited in study report): H-20206, Octanol, titanium(4+) salt, branched and linear
- Substance type: organometal
- Physical state: liquid
- Analytical purity: 100%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hare Marland, Hewitt, New Jersey
- Age at study initiation: Young adults
- Weight at study initiation: 2649g and 2563g at the day of treatment
- Housing: singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): 125 grams of Purina Certified High Fiber Rabbit Chow #5323 daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 2 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 2°C
- Humidity (%): 50% +/- 10%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.01 ml
Duration of treatment / exposure:
0.01 ml placed into the lower conjunctival sac of each right eye. After 20 seconds both eyes of one rabbit were rinsed for 1 minute with room temperature water. The treated and control eyes of the remaining rabbit were not washed. Observations were made up to day 3 for the washed rabbit eye and up to day 21 for the unwashed rabbit eye.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
2
Details on study design:
0.01 ml of undiluted test material was placed into the right conjunctival sac of each of 2 female New Zealand White rabbits. After 20 seconds, both eyes of one rabbit were washed with water. The treated and control eyes of the other rabbit were not washed. Observations of the cornea, iris and conjunctiva were made using illumination and magnification and scored according to Draize scale. Observations were made at 1 and 4 hours, and at 1, 2, 3 days for the washed rabbit eye and at 1 and 4 hours, and at 1, 2, 3, 7, 14, and 21 days for the unwashed rabbit eye. Treated eyes were also observed for any responses to treatment such as pannus, blistering of the conjunctiva, ulceration, or other effects indicative of corrosive action. Hemastix reagent strip® were used to detect occult blood in discharge from the eye.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Remarks:
area
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.2
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
The test substance produced slight corneal opacity, moderate iritis, mild chemosis, and blistering of the conjunctiva and nictitating membrane in both treated eyes. Severe conjunctival redness and copious blood-tinged discharge were observed in the treated unwashed eye. Moderate conjuctival redness and moderate blood-tinged discharge were observed in the treated washed eye. The washed and unwashed eyes were normal by 3 and 21 days, respectively, following treatment.

Any other information on results incl. tables

Rabbit 28203unwashed eye  1 hour 4 hour  1 day   2 days  3 days  7 days  14 days  21 days
 Cornea                
  Opacity  1  0  0  0  0
  Area  4  4  0  0  0  0  0  0
 Iris  0  1  1  0  0  0  0  0

 Conjuctiva

               
  Redness 2B   2B  3  3  2  2  1  0
  Chemosis  2  2  2  1  1  1  1  0
  Discharge  3H+  3H+  3H+  0  0  0  0  0

 Rabbit 28220washed eye  1 hour 4 hour  1 day   2 days  3 days     
 Cornea                
  Opacity  1  0      
  Area  4  4  0  0  0      
 Iris  1  1  0  0  0      
 Conjuctiva                
  Redness 2B   2B  2  2  0      
  Chemosis  2  2  1  1  0      
  Discharge  1H+  2H+  0  0  0      

B+ = Hemastix evaluations positive for blood

B = Blistering of the conjunctiva and nictitating membrane

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The eye irritation potential of Titanium tetra(octanolate), branched and linear was evaluated when introduced to the eyes of rabbits. The test material is considered a severe eye irritant. The study predates current guideline study, but is perfomed in similar way than OECD 405 study.
Executive summary:

Titanium tetra(octanolate), branched and linear was applied undiluted into the eyes of two rabbits. After 20 seconds, both eyes of one rabbit were washed with water. The treated and control eyes of the other rabbit were not washed. Observations were made at 1 and 4 hours, and at 1, 2, 3 days for the washed rabbit eye and at 1 and 4 hours, and at 1, 2, 3, 7, 14, and 21 days for the unwashed rabbit eye. The test material caused slight to severe, but reversible, ocular lesions in the eyes of rabbits.

By the study report the test material is considered a severe eye irritant. This study was regarded reliable with restrictions, since there is few minor deviations from the current guideline (0.01ml test material was introduced into the rabbit eye and the eye of the one rabbit was washed at 20 seconds after treatment). The result of this study is used as a key value in hazard assessment.