Ilmenite (FeTiO3), conc.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2006-05-25 to 2006-07-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study; self-certified statement of compliance is missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Titanium dioxide

EC Number:

236-675-5

EC Name:

Titanium dioxide

Cas Number:

13463-67-7

IUPAC Name:

dioxotitanium

Constituent 2

Reference substance name:

Rutile (TiO2)

EC Number:

215-282-2

EC Name:

Rutile (TiO2)

Cas Number:

1317-80-2

IUPAC Name:

dioxotitanium

Details on test material:

- Name of test material (as cited in study report): Titanium dioxide, Ultrafine (H-27416)
- Substance type: white solid
- Analytical purity: 89.3%
- Impurities (identity and concentrations): 7.2% Aluminum hydroxide; 1.1% Amorphous silica; 2.4% organic coatings
No further details are given.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Age at study initiation: young adult
- Housing: All animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
- Diet: approximately 125 grams of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily during the study
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod: 12-hour light/dark cycle
No further details are given.

Test system

Vehicle:

water

Controls:

other: left eye of each rabbit served as control

Amount / concentration applied:

57 mg

Duration of treatment / exposure:

single administration

Observation period (in vivo):

1, 24, 48, and 72 hours following administration of the test substance

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

Approximately 57 mg of H-27416 was introduced into the lower conjunctival sac of the right eye of each rabbit. The left eye of each rabbit was not treated with the test substance and served as a control. The eyes remained unwashed following treatment. Each rabbit was observed for approximately 30 to 60 seconds before being returned to its cage. One rabbit was initially treated. Since no severe irritation or corrosion was observed, 2 additional rabbits were treated to complete the test.
The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to the Draize Scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 1 hour

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: only observed effect

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24 hours

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: only observed effect

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 48-72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: only observed effect

Irritant / corrosive response data:

The test substance produced conjunctival redness (score of 1 or 2) in the treated eye of all three rabbits. Fluorescein stain examinations were negative for corneal injury. The treated eyes of the rabbits were normal by 24 or 48 hours after instillation of the test substance.

Other effects:

No clinical signs were observed, and no body weight loss occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, titanium dioxide (sample: H-27416) produced conjunctival redness in the treated rabbit eye.
In accordance with the provisions of Directive 67/548/EEC, classification is not required based on the results of this study.