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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform
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

Resultsopen allclose all
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
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
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:
GHS criteria not met
Conclusions:
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. Titanium dioxide is not irritating to the eye.