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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
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

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
Chemical structure
Reference substance name:
Rutile (TiO2)
EC Number:
215-282-2
EC Name:
Rutile (TiO2)
Cas Number:
1317-80-2
Molecular formula:
O2Ti
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.

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.