Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (non-GLP, occlusive coverage, no washing after 24 h exposure)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register 38, No. 187, § 1500.41, S. 27019, 27. Sept. 1973
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: solid
- Composition of test material, percentage of components: TiO2: 78.9 %, Sb2O5: 15.5 %, NiO 4.1 %, SiO2: 1.5 % (cross-contamination with material from ball mill) As: 40 ppm, Pb: 130 ppm, Cu: 4 ppm, Zn: 10 ppm

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.50 kg
- Diet: ad libitum, Sniff

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 mL
- Concentration: 50 % aqueous solution
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6 (4 male, 2 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: Draize, J.H. (1959): Dermal Toxicity. In: FDA-Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Remarks on result:
other: Evaluation of erythema after 24 hrs not possible due to treatment related staining.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Abraded skin
Erythema: No data after 24 h. After 72 h questionable to slight erythema in 3/5 animals (1 animal evaluation impossible due to substance-related staining). Scaling was observed in 4 animals after 8 days.
Edema: No effects were seen throughout the study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU