potassium titanium oxide (K2Ti6O13)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 July 1999 to 18 July 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

(Annex V of Council Directive 67/548/EEC)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

(Date of inspection: 23 March 1998 Date of Signature: 21 July 1998)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-240-0

EC Name:

-

Cas Number:

12056-51-8

Molecular formula:

K2Ti6O13

IUPAC Name:

Potassium hexatitanate

Details on test material:

- Substance type: Pale yellow solid.
- Physical state: Solid (powder).
- Lot/batch No.: A-8838.
- Storage condition of test material: Room temperature in the dark.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, United Kingdom.
- Age at study initiation: 12 - 16 weeks old.
- Weight at study initiation: 2.43 - 2.63 kg.
- Housing: The animals were individually housed in suspended metal cages.
- Diet : STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, United Kingdom, ad libitum.
- Water : Mains water, ad libitum.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C.
- Humidity (%): 30 - 70%.
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eyes in the exposed animals were used for control.

Amount / concentration applied:

91 mg (equivalent to a volume of 0.1 ml)

Duration of treatment / exposure:

1, 24, 48 and 72 hours.

Observation period (in vivo):

(1, 24, 48 and 72 hours)

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.


SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the grading in the test guideline. The result was classified according to EU classification system.


TOOL USED TO ASSESS SCORE: The light source from a standard ophthalmoscope.


OTHERS
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular lesions were used. Initially, a single rabbit was treated. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first animal, two additional animals were treated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(110 Male)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: The highest score of 1 observed at 1 hour.

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(143 Male)

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: The highest score of 2 was observed at 1 hour. Score of 1 was observed at 24 and 48 hour.

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(144 Male)

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: The highest score of 2 was observed at 1 hour. Score of 1 was observed at 24 and 48 hour.

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(110 Male)

Time point:

24/48/72 h

Score:

0

Max. score:

1

Remarks on result:

other: The highest score of 1 was observed at 1 hour.

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(143 Male)

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: The highest score of 1 was observed at 1 and 24 hour.

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(144 Male)

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: The highest score of 2 was observed at 1 hour. Score of 1 was observed at 24 hour.

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(110 Male)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(143 Male)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(144 Male)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(110 Male)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(143 Male)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(144 Male)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

See table for the results. No corneal or iridial effects were noted during the study.

Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. Minimal conjunctival irritation was noted in two treated eyes at the 24 and 48-hour observations.

Reversibility of any observed effect: Changes fully reversible within 3 days.

Other effects:

Not reported.


Minimal to moderate conjunctival irritation was noted in all
treated eyes at the 1-hour observation.

All eyes appeared normal at the 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material did not produce positive criteria in any rabbit therefore the test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

During the study 91 mg of test material was instilled in the eyes of 3 New Zealand White rabbits. Signs of ocular irritation were observed over a period of 72 hours.

A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. All treated eyes appeared normal at the 72-hour observation.

The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).