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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
There is no study period reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across to titanium tetraisopropanoate (EC 208-909-6) and analogue substances The test procedure predates current guideline, but it is comparable with OECD 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Final score at 7 days rather than 21 days. No irritation results presented at 1hour after test item application and at 7 days.
Principles of method if other than guideline:
Test item was applied in the conjuctival sac of one eye. The second, untreated eye, served as a control. Irritation of eyes were observed at 1, 24, 48, 72 hours and 7 days after test item application.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isopropyl titanate; Inbifo number: S 2575 A1
- Substance type: organometal
- Physical state: liquid

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: 3-4 kg
- Housing: stainless steel cage without litter
- Diet (e.g. ad libitum): standard pellet for rabbit ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: >3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml was placed into the conjunctival sac of one eye by means of a tuberculin syringe (without a needle).
Duration of treatment / exposure:
Single treatment followed by 7 day observation period.
Observation period (in vivo):
7 days.
Number of animals or in vitro replicates:
6
Details on study design:
For each animal there was a comparison of treated and untreated eye and classification of findings according to Draize scale. Recordings were made at 1 h, 24 h, 48 h and 72 h after instillation. In case, irritation was observed at 72 hours observation was performed at 7 days.

SCORING SYSTEM:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
18 animals
Time point:
other: 24, 48, 72 hrs
Score:
30.3
Max. score:
110
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
18 animals
Time point:
other: 24, 48, 72 hrs
Score:
16.6
Max. score:
80
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Remarks:
18 animals
Time point:
other: 24, 48, 72 hrs
Score:
0.9
Max. score:
10
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
18 animals
Time point:
other: 24, 48, 72 hrs
Score:
9.8
Max. score:
20
Reversibility:
not specified
Irritant / corrosive response data:
The irritation index for the titanium tetrapropanolate was 30.3
Other effects:
1 h after application: Redness and swelling of the conjunctiva and strong secretion were recorded. Also recorded was a white-yellowish, sliding pad on the cornea; this was tentatively considered to be the test item
24 h to 72 h after application: Purulent surface in five rabbits was recorded.
7 d after application: No significant change from the 72 h findings was reported.

Any other information on results incl. tables

 

24 hours

48 hours

72 hours

Rabbit numbers

1

2

3

4

5

6

1

2

3

4

5

6

1

2

3

4

5

6

Cornea opacity (a)

0

1

0

1

1

1

0

1

0

1

1

1

0

2

0

2

2

1

Area of cornea (b)

0

4

0

4

4

4

0

4

0

4

4

4

0

4

0

4

4

4

1: a x b x 5 (max 80)

0

20

0

20

20

20

0

20

0

20

20

20

0

40

0

40

40

20

Iris score

1

1

1

1

1

1

0

1

0

1

1

1

0

1

0

1

1

1

2: Iris score x 5

5

5

5

5

5

5

0

5

0

5

5

5

0

5

0

5

5

5

Conjunctivae redness (a)

2

2

1

2

1

1

1

1

1

2

2

2

1

1

1

2

2

2

Conjunctivae chemosis (b)

2

2

1

3

4

2

1

2

1

1

3

1

1

2

1

1

1

2

Conjunctivae discharge (c)

3

3

2

3

3

3

1

2

0

3

3

1

0

2

0

0

0

1

3: a x b x c x 2 (max 20)

14

14

8

16

16

12

6

10

4

12

16

8

4

10

4

6

6

10

Score 1 + 2 + 3 (max 110)

19

39

13

41

41

37

6

35

4

37

41

33

4

55

4

51

51

35

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Eye irritation properties of titanium tetraisopropanolate was evaluated after test item administration to rabbit eye. The test substance was classified as moderately irritating.
Executive summary:

Eye irritation potential of titanium tetraisopropanolate was evaluated by administering test substance into eye of six rabbits. Eye responses were recorded at 1h, 24h, 48h, 72h and 7 days after test item application and the responses were evaluated according to Draize scale.

The study is considered reliable with restrictions, since the test procedure predates current guideline, but it is comparable with OECD 405 guideline study. Although the assessment of reversibility of eye responses finished at 7 days after application it was noted that at 7 days there was no significant change from the findings at 72 hours.

By the study report, titanium tetraisopropanolate was classified moderately irritating.