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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Test material

Constituent 1
Reference substance name:
Antimony nickel titanium oxide yellow
EC Number:
232-353-3
EC Name:
Antimony nickel titanium oxide yellow
Cas Number:
8007-18-9
IUPAC Name:
8007-18-9
Constituent 2
Reference substance name:
C.I. Pigment Yellow 53
IUPAC Name:
C.I. Pigment Yellow 53
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 or test system 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