Registration Dossier
Registration Dossier
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EC number: 308-551-1 | CAS number: 98072-94-7 Natural ilmenite ore is concentrated by selective removal of impurities, chiefly iron, to yield a product enriched in titanium dioxide. The process consists of an optional oxidative roast followed by a reductive roasting stage, an acidic leaching stage and washing and drying the product. Alternatively the process consists of selectively chlorinating the iron oxide present in the reduced ore.
Skin irritation / corrosion
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:
- 2 006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC 92/69/EEC (1992)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.2500 (1998)
- GLP compliance:
- no
Test material
- Reference substance name:
- Titanium dioxide
- EC Number:
- 236-675-5
- EC Name:
- Titanium dioxide
- Cas Number:
- 13463-67-7
- IUPAC Name:
- dioxotitanium
- 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): 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.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
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