Titanium 2,2',2''-nitrilotrisethanolate

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Titanium 2,2',2''-nitrilotrisethanolate

EC Number:

240-015-1

EC Name:

Titanium 2,2',2''-nitrilotrisethanolate

Cas Number:

15879-01-3

Molecular formula:

C6H15NO3.xTi

IUPAC Name:

titanium 2,2',2''-nitrilotrisethanolate

Test material form:

liquid

Details on test material:

Test Item Name Tyzor TE
IUPAC Name titanium 2,2',2''-nitrilotrisethanolate
CAS No. 15879-01-3
EC No. 240-015-1
Appearance Light yellow liquid
manufactured by Dorf Ketal Speciality Catalyst Pvt Limited

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2,0-2,3 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

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

42

Max. score:

110

Remarks on result:

probability of moderate irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

26.7

Max. score:

80

Reversibility:

fully reversible within: 14 days

Remarks on result:

not determinable

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

3.9

Max. score:

10

Reversibility:

fully reversible within: 8 days

Remarks on result:

not determinable

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

11.5

Max. score:

20

Reversibility:

fully reversible within: 16 days

Remarks on result:

not determinable

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.56

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The eye irritation potential of titanium 2,2´,2´´-nitrilotrisethanolate was evaluated when introduced to the eyes of male rabbits. The test material demonstrated a moderate irritant effect on the eye and mucosa of rabbit with irritation index of 42/110 according to the Draize.

Executive summary:

Titanium 2,2´,2´´-nitrilotrisethanolate 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.

Titanium 2,2´,2´´-nitrilotrisethanolateirritated moderately the cornea and conjunctiva of rabbit eyes. All treatment related effects were fully reversible within 16 days.