Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2006-05-10 to 2006-07-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study; no GLP compliance statement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EEC 92/69/EEC (1992)
Qualifier:
according to
Guideline:
other: EPA OPPTS 870.2500 (1998)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TiO2 (ultrafine TiO2)
- Physical state: white solid
- Analytical purity: 89.3%
- Impurities (identity and concentrations): 7.2% Aluminium hydroxide, 1.1% amorphous Silica, 2.4% organic coatings
No further details are given.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Weight at study initiation: 3290 - 3915 g
- 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
- Photoperiod: 12-hour light/dark cycle
No further details are given.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped skin on the back
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5g, moistened with 0.25 ml deionised water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal
Number of animals:
3 male
Details on study design:
Removal of TiO2 with warm water. Scoring after Draize. Measurement of body weight and observation of clinical signs.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
The rabbits exhibited no dermal irritation during the study.
Other effects:
No clinical signs of toxicity 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:
According to the criteria specified by Directive 67/548/EC and subsequent regulations the test item is no skin irritant and requires no classification.